Effect of High Doses of Radiation on Bone Structure and Metabolism

• Sponsor: Massachusetts General Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02323295
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 12
• Location: 1
• Arms: 2
• Duration (Months): 48
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

This study is designed to characterize the effects of high energy radiation on bone breakdown, with a specific interest in reducing the rate of sacral fractures. Although radiation is very important in managing tumors, it is related to complications such as bone fractures. In this research study, the investigators are looking to determine changes in blood markers, bone density, and bone structure following radiation and to better understand the reason for these changes.

Condition or Disease	Intervention/Treatment	Phase
Malignant Bone Tumors	Radiation: Radiation (Surgical Arm); Radiation: Radiation (Non-surgical Arm); Procedure: Malignant Tumor Surgery	N/A

Detailed Description

Participants in the Surgical Arm of the study will be treated according to the schedule outlined in protocol for a combined treatment with surgery and adjuvant high dose radiotherapy. Patients in the non surgical arm of the the study will be treated according to the protocol being treated with radiotherapy alone.

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Pilot Study of the Effect of High Doses of Radiation on Bone Metabolism and Structure in Patients Treated With Adjuvant Radiotherapy and Surgery for Sacral Tumors
• Study Start Date: Jul 1, 2015
• Actual Primary Completion Date: Jul 1, 2019
• Actual Study Completion Date: Jul 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Non Surgical-Radiation Only Non-surgical candidates receive 72 up to 77.l4 Gy of radiation depending on the histology (72 Gy for osteosarcoma and chondrosarcoma and 77.4 Gy for chordoma	Radiation: Radiation (Non-surgical Arm); Non-surgical candidates receive 72 up to 77.14 Gy of radiation depending on the histology (72 Gy for osteosarcoma and chondrosarcoma and 77.4 Gy for chordoma)
Experimental: Malignant Tumor Surgery And Radiation The standard treatment includes pre-operative radiation of 50.4 Gy, followed by a recovery period of approximately 4 to 5 weeks. Surgery involves removing the malignant tumor in the sacrum in one piece, preferably with a cuff of normal tissue around the tumor. After approximately 6 weeks of recovery, the patient is treated with another 19.8 Gy up to 27 Gy of radiation postoperatively depending on the final margin status (higher for gross residual disease). If the wound is not healed or there is another medical reason to delay adjuvant radiation, then radiation may begin later.	Radiation: Radiation (Surgical Arm); For surgical candidates, the standard treatment includes pre-operative radiation of 50.4 Gy, followed by a recovery period of approximately 4 to 5 weeks. After this surgery will take place. After approximately 6 weeks of recovery, to allow the surgical incision to heal, the patient is treated with another 19.8 Gy up to 27 Gy of radiation postoperatively depending on the final margin status (higher for gross residual disease); Procedure: Malignant Tumor Surgery; Surgery involves removing the malignant tumor in the sacrum in one piece, preferably with a cuff of normal tissue around the tumor

Outcome Measures

Primary Outcome Measures

1. Change in Bone Mineral Density (Tb. BMD) [Non-surgical arm: baseline, 3 months Surgical arm: baseline, 9 weeks]

   Trabecular bone mineral density will be measured in mg/cm3 using volumetric Quantitative Computed Tomography (QCT) of L1, L2 and the vertebrae adjacent to the tumor.

Secondary Outcome Measures

1. Serum N-Telopeptide (NTX) [Non-surgical arm: baseline, 3.5 weeks, 7 weeks, ~5 months, ~8 months Surgical arm: baseline, 5.5 weeks, 18.5 weeks, ~7 months, ~10 months]

   Indicator for Bone Formation, units reported in nmol NTX/mmol creatinine

2. Serum Tartrate-resistant Acid Phosphatase 5b (TRAP5b) [Non-surgical arm: baseline, 3.5 weeks, 7 weeks, ~5 months, ~8 months Surgical arm: baseline, 5.5 weeks, 18.5 weeks, ~7 months, ~10 months]

   Indicator for Bone Formation, units reported in U/L

3. Serum Osteocalcin (OC) [Non-surgical arm: baseline, 3.5 weeks, 7 weeks, ~5 months, ~8 months Surgical arm: baseline, 5.5 weeks, 18.5 weeks, ~7 months, ~10 months]

   Indicator for Bone Formation, units reported in ng/mL

4. Serum Type 1 Procollagen N-terminal (P1NP) [Non-surgical arm: baseline, 3.5 weeks, 7 weeks, ~5 months, ~8 months Surgical arm: baseline, 5.5 weeks, 18.5 weeks, ~7 months, ~10 months]

   Indicator for systemic metabolism that can affect bone health, units reported in pg/mL

5. Serum Phosphate (P) [Non-surgical arm: baseline, 3.5 weeks, 7 weeks, ~5 months, ~8 months Surgical arm: baseline, 5.5 weeks, 18.5 weeks, ~7 months, ~10 months]

   Indicators for systemic metabolism that can affect bone health, units reported in mg/dL

6. Serum 25-hydroxycalciferol Vit D (25-OH VitD) [Non-surgical arm: baseline, 3.5 weeks, 7 weeks, ~5 months, ~8 months Surgical arm: baseline, 5.5 weeks, 18.5 weeks, ~7 months, ~10 months]

   Indicators for systemic metabolism that can affect bone health, units reported in nmol/L

7. Mineral Apposition Rate (MAR) [Only surgical arm: The months after biopsies are taken during surgery (surgery is during week 4 and 5). These measurements will be done in batches so timeframe isn't clear.]

   Tetracycline quadruple labeling method will be used and the unit of measure will be um/day

8. Bone Formation Rate (BFR/BS) [Only surgical arm: The months after biopsies are taken during surgery (surgery is during week 4 and 5). These measurements will be done in batches so timeframe isn't clear.]

   Tetracycline quadruple labeling method will be used and the unit of measure will be mm3/mm2/year

9. Mineralization Lag Time (Mlt) [Only surgical arm: The months after biopsies are taken during surgery (surgery is during week 4 and 5). These measurements will be done in batches so timeframe isn't clear.]

   Tetracycline quadruple labeling method will be used and the unit of measure will be days

10. Osteoblast Number (N.Ob/BPm) [Only surgical arm: The weeks after biopsies are taken during surgery (surgery is during week 4 and 5).]

    Immunohistochemistry staining methods will be used and the unit of measure will be mm^-1

11. Osteoblast Surface (Ob. S/BS) [Only surgical arm: The weeks after biopsies are taken during surgery (surgery is during week 4 and 5).]

    Immunohistochemistry staining methods will be used and the unit of measure will be mm^-1

12. Osteoclast Number (N.Oc/BPm) [Only surgical arm: The weeks after biopsies are taken during surgery (surgery is during week 4 and 5).]

    Immunohistochemistry staining methods will be used and the unit of measure will be mm^-1

13. Osteoclast Surface (Oc.S/BS) [Only surgical arm: The weeks after biopsies are taken during surgery (surgery is during week 4 and 5).]

    Immunohistochemistry staining methods will be used and the unit of measure will be mm^-1

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• All laboratory tests that are a part of the eligibility criteria must be completed within 14 days prior to the date of registration. Diagnostic tests that are a part of the eligibility criteria must be performed within 30 days of the date of registration. Participants must meet the following criteria on screening examination to be eligible to participate in the study:

• Study participants must have histologically confirmed primary malignant bone tumor in the sacrum for which surgery and radiation or radiation alone are planned.

• Age 18 years or older. In children under the age of 8, tetracycline derivatives have been reported to stain tooth enamel yellow color. These considerations lead us to exclude young persons under the age of 18 from the study.

• Participants must have normal organ and marrow function as defined below:

• Total bilirubin within normal institutional limits

• Aspartaataminotransferase (AST) (SGOT)/ Alanine-aminotransferase (ALT) (SGPT) < 2.5 X institutional upper limit of normal

• Creatinine within normal institutional limits or creatinine clearance > 60 mL/min/1.73 m2 for subjects with creatinine levels about institutional normal limit

• The effects of tetracyclines and radiation used in computer tomography on the developing human fetus are known to be detrimental. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.

• Participants must be able to read and understand English language and have the ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study.

• Participants who have had surgery, chemotherapy, or radiotherapy of the sacrum prior to entering the study

• History of allergic reactions attributed to compounds of similar chemical or biologic composition to tetracyclines.

• Pregnant or nursing

• Uncontrolled inter current illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02114

Sponsors and Collaborators

• Massachusetts General Hospital
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Joseph H. Schwab, MD, Massachusetts General Hospital

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 5, 2016
• Informed Consent Form - Apr 10, 2017

More Information

Publications

None provided.

• Responsible Party: Schwab, Joseph H., Instructor in Orthopaedic Surgery, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT02323295
• Other Study ID Numbers: 14-208; C06CA059267
• First Posted: Dec 23, 2014
• Last Update Posted: Dec 7, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by Schwab, Joseph H., Instructor in Orthopaedic Surgery, Massachusetts General Hospital: Malignant bone tumors
• Additional relevant MeSH terms: Bone Neoplasms

Study Results

Participant Flow

Arm/Group Title	Non Surgical-Radiation Only	Malignant Tumor Surgery And Radiation
Arm/Group Description	Non-surgical candidates receive 72 up to 77.l4 Gy of radiation depending on the histology (72 Gy for osteosarcoma and chondrosarcoma and 77.4 Gy for chordoma Radiation: For surgical candidates, the standard treatment includes pre-operative radiation of 50.4 Gy, followed by a recovery period of approximately 4 to 5 weeks. After this surgery will take place. After approximately 6 weeks of recovery, to allow the surgical incision to heal, the patient is treated with another 19.8 Gy up to 27 Gy of radiation postoperatively depending on the final margin status (higher for gross residual disease) Non-surgical candidates receive 72 up to 77.14 Gy of radiation depending on the histology (72 Gy for osteosarcoma and chondrosarcoma and 77.4 Gy for chordoma)	The standard treatment includes pre-operative radiation of 50.4 Gy, followed by a recovery period of approximately 4 to 5 weeks. Surgery involves removing the malignant tumor in the sacrum in one piece, preferably with a cuff of normal tissue around the tumor. After approximately 6 weeks of recovery, the patient is treated with another 19.8 Gy up to 27 Gy of radiation postoperatively depending on the final margin status (higher for gross residual disease). If the wound is not healed or there is another medical reason to delay adjuvant radiation, then radiation may begin later. Radiation: For surgical candidates, the standard treatment includes pre-operative radiation of 50.4 Gy, followed by a recovery period of approximately 4 to 5 weeks. After this surgery will take place. After approximately 6 weeks of recovery, to allow the surgical incision to heal, the patient is treated with another 19.8 Gy up to 27 Gy of radiation postoperatively depending on the final margin status (higher for gross residual disease) Non-surgical candidates receive 72 up to 77.14 Gy of radiation depending on the histology (72 Gy for osteosarcoma and chondrosarcoma and 77.4 Gy for chordoma) Malignant Tumor Surgery: Surgery involves removing the malignant tumor in the sacrum in one piece, preferably with a cuff of normal tissue around the tumor
Period Title: Overall Study
STARTED	2	10
COMPLETED	2	7
NOT COMPLETED	0	3

Baseline Characteristics

Arm/Group Title	Non Surgical-Radiation Only	Malignant Tumor Surgery And Radiation	Total
Arm/Group Description	Non-surgical candidates receive 72 up to 77.l4 Gy of radiation depending on the histology (72 Gy for osteosarcoma and chondrosarcoma and 77.4 Gy for chordoma Radiation: For surgical candidates, the standard treatment includes pre-operative radiation of 50.4 Gy, followed by a recovery period of approximately 4 to 5 weeks. After this surgery will take place. After approximately 6 weeks of recovery, to allow the surgical incision to heal, the patient is treated with another 19.8 Gy up to 27 Gy of radiation postoperatively depending on the final margin status (higher for gross residual disease) Non-surgical candidates receive 72 up to 77.14 Gy of radiation depending on the histology (72 Gy for osteosarcoma and chondrosarcoma and 77.4 Gy for chordoma)	The standard treatment includes pre-operative radiation of 50.4 Gy, followed by a recovery period of approximately 4 to 5 weeks. Surgery involves removing the malignant tumor in the sacrum in one piece, preferably with a cuff of normal tissue around the tumor. After approximately 6 weeks of recovery, the patient is treated with another 19.8 Gy up to 27 Gy of radiation postoperatively depending on the final margin status (higher for gross residual disease). If the wound is not healed or there is another medical reason to delay adjuvant radiation, then radiation may begin later. Radiation: For surgical candidates, the standard treatment includes pre-operative radiation of 50.4 Gy, followed by a recovery period of approximately 4 to 5 weeks. After this surgery will take place. After approximately 6 weeks of recovery, to allow the surgical incision to heal, the patient is treated with another 19.8 Gy up to 27 Gy of radiation postoperatively depending on the final margin status (higher for gross residual disease) Non-surgical candidates receive 72 up to 77.14 Gy of radiation depending on the histology (72 Gy for osteosarcoma and chondrosarcoma and 77.4 Gy for chordoma) Malignant Tumor Surgery: Surgery involves removing the malignant tumor in the sacrum in one piece, preferably with a cuff of normal tissue around the tumor	Total of all reporting groups
Overall Participants	2	10	12
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	1 50%	9 90%	10 83.3%
>=65 years	1 50%	1 10%	2 16.7%
Sex: Female, Male (Count of Participants)
Female	1 50%	2 20%	3 25%
Male	1 50%	8 80%	9 75%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%
Not Hispanic or Latino	2 100%	10 100%	12 100%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	1 50%	0 0%	1 8.3%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	1 50%	10 100%	11 91.7%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Change in Bone Mineral Density (Tb. BMD)
Description	Trabecular bone mineral density will be measured in mg/cm3 using volumetric Quantitative Computed Tomography (QCT) of L1, L2 and the vertebrae adjacent to the tumor.
Time Frame	Non-surgical arm: baseline, 3 months Surgical arm: baseline, 9 weeks

Outcome Measure Data

Analysis Population Description

Subjects 4 and 9 are in the non-surgical radiation group and only have values for that column. The rest of the subjects are in the malignant tumor surgery and radiation and only have values in that column.

Arm/Group Title	Non Surgical-Radiation Only	Malignant Tumor Surgery And Radiation
Arm/Group Description	Non-surgical candidates receive 72 up to 77.l4 Gy of radiation depending on the histology (72 Gy for osteosarcoma and chondrosarcoma and 77.4 Gy for chordoma Radiation: For surgical candidates, the standard treatment includes pre-operative radiation of 50.4 Gy, followed by a recovery period of approximately 4 to 5 weeks. After this surgery will take place. After approximately 6 weeks of recovery, to allow the surgical incision to heal, the patient is treated with another 19.8 Gy up to 27 Gy of radiation postoperatively depending on the final margin status (higher for gross residual disease) Non-surgical candidates receive 72 up to 77.14 Gy of radiation depending on the histology (72 Gy for osteosarcoma and chondrosarcoma and 77.4 Gy for chordoma)	The standard treatment includes pre-operative radiation of 50.4 Gy, followed by a recovery period of approximately 4 to 5 weeks. Surgery involves removing the malignant tumor in the sacrum in one piece, preferably with a cuff of normal tissue around the tumor. After approximately 6 weeks of recovery, the patient is treated with another 19.8 Gy up to 27 Gy of radiation postoperatively depending on the final margin status (higher for gross residual disease). If the wound is not healed or there is another medical reason to delay adjuvant radiation, then radiation may begin later. Radiation: For surgical candidates, the standard treatment includes pre-operative radiation of 50.4 Gy, followed by a recovery period of approximately 4 to 5 weeks. After this surgery will take place. After approximately 6 weeks of recovery, to allow the surgical incision to heal, the patient is treated with another 19.8 Gy up to 27 Gy of radiation postoperatively depending on the final margin status (higher for gross residual disease) Non-surgical candidates receive 72 up to 77.14 Gy of radiation depending on the histology (72 Gy for osteosarcoma and chondrosarcoma and 77.4 Gy for chordoma) Malignant Tumor Surgery: Surgery involves removing the malignant tumor in the sacrum in one piece, preferably with a cuff of normal tissue around the tumor
Measure Participants	2	7
Subject 2 (lumbar)	4.5
Subject 2 (sacral)	-39.3
Subject 3 (lumbar)	-8.7
Subject 3 (sacral)	-54.7
Subject 4 (lumbar)	4.1
Subject 4 (sacral)	5.2
Subject 6 (lumbar)	-2.6
Subject 6 (sacral)	-32.7
Subject 7 (lumbar)	3.6
Subject 7 (sacral)	-14.8
Subject 8 (lumbar)	-2.2
Subject 8 (sacral)	-57.7
Subject 9 (lumbar)	-3.5
Subject 9 (sacral)	-55.7
Subject 10 (lumbar)	-0.2
Subject 10 (sacral)	-70.3
Subject 12 (lumbar)	3.3
Subject 12 (sacral)	-37.9

2. Secondary Outcome

Title	Serum N-Telopeptide (NTX)
Description	Indicator for Bone Formation, units reported in nmol NTX/mmol creatinine
Time Frame	Non-surgical arm: baseline, 3.5 weeks, 7 weeks, ~5 months, ~8 months Surgical arm: baseline, 5.5 weeks, 18.5 weeks, ~7 months, ~10 months

Outcome Measure Data

Analysis Population Description

Subjects 4 and 9 are in the non-surgical radiation group and only have values for that column. The rest of the subjects are in the malignant tumor surgery and radiation and only have values in that column. For other missing values, certain tests were not performed at certain timepoints for some subjects.

Arm/Group Title	Non Surgical-Radiation Only	Malignant Tumor Surgery And Radiation
Arm/Group Description	Non-surgical candidates receive 72 up to 77.l4 Gy of radiation depending on the histology (72 Gy for osteosarcoma and chondrosarcoma and 77.4 Gy for chordoma Radiation: For surgical candidates, the standard treatment includes pre-operative radiation of 50.4 Gy, followed by a recovery period of approximately 4 to 5 weeks. After this surgery will take place. After approximately 6 weeks of recovery, to allow the surgical incision to heal, the patient is treated with another 19.8 Gy up to 27 Gy of radiation postoperatively depending on the final margin status (higher for gross residual disease) Non-surgical candidates receive 72 up to 77.14 Gy of radiation depending on the histology (72 Gy for osteosarcoma and chondrosarcoma and 77.4 Gy for chordoma)	The standard treatment includes pre-operative radiation of 50.4 Gy, followed by a recovery period of approximately 4 to 5 weeks. Surgery involves removing the malignant tumor in the sacrum in one piece, preferably with a cuff of normal tissue around the tumor. After approximately 6 weeks of recovery, the patient is treated with another 19.8 Gy up to 27 Gy of radiation postoperatively depending on the final margin status (higher for gross residual disease). If the wound is not healed or there is another medical reason to delay adjuvant radiation, then radiation may begin later. Radiation: For surgical candidates, the standard treatment includes pre-operative radiation of 50.4 Gy, followed by a recovery period of approximately 4 to 5 weeks. After this surgery will take place. After approximately 6 weeks of recovery, to allow the surgical incision to heal, the patient is treated with another 19.8 Gy up to 27 Gy of radiation postoperatively depending on the final margin status (higher for gross residual disease) Non-surgical candidates receive 72 up to 77.14 Gy of radiation depending on the histology (72 Gy for osteosarcoma and chondrosarcoma and 77.4 Gy for chordoma) Malignant Tumor Surgery: Surgery involves removing the malignant tumor in the sacrum in one piece, preferably with a cuff of normal tissue around the tumor
Measure Participants	2	7
Subject 2 (baseline)	21.711
Subject 2 (5.5 weeks)	17.76
Subject 2 (18.5 Weeks)	31.447
Subject 2 (about 7 months)	24.376
Subject 2 (about 10 months)	21.889
Subject 3 (baseline)	11.217
Subject 3 (5.5 weeks)	14.294
Subject 4 (baseline)	4.614
Subject 4 (3.5 weeks)	7.366
Subject 4 (7 weeks)	6.205
Subject 4 (about 8 months)	7.218
Subject 6 (baseline)	15.932
Subject 6 (5.5 weeks)	19.973
Subject 6 (18.5 weeks)	20.922
Subject 6 (about 7 months)	16.707
Subject 6 (about 10 months)	14.096
Subject 7 (baseline)	15.949
Subject 7 (5.5 weeks)	8.942
Subject 7 (18.5 weeks)	25.817
Subject 7 (about 10 months)	18.513
Subject 8 (baseline)	11.97
Subject 8 (5.5 weeks)	19.065
Subject 8 (18.5 weeks)	22.917
Subject 8 (about 7 months)	26.767
Subject 8 (about 10 months)	18.116
Subject 9 (baseline)	8.028
Subject 9 (3.5 weeks)	12.435
Subject 9 (7 weeks)	7.642
Subject 9 (about 5 months)	11.163
Subject 9 (about 8 months)	11.155
Subject 10 (baseline)	11.082
Subject 10 (5.5 weeks)	7.763
Subject 10 (18.5 weeks)	10.123
Subject 10 (about 7 months)	9.89
Subject 12 (baseline)	12.656
Subject 12 (5.5 weeks)	10.511
Subject 12 (18.5 weeks)	14.693
Subject 12 (about 7 months)	15.177

3. Secondary Outcome

Title	Serum Tartrate-resistant Acid Phosphatase 5b (TRAP5b)
Description	Indicator for Bone Formation, units reported in U/L
Time Frame	Non-surgical arm: baseline, 3.5 weeks, 7 weeks, ~5 months, ~8 months Surgical arm: baseline, 5.5 weeks, 18.5 weeks, ~7 months, ~10 months

Outcome Measure Data

Analysis Population Description

Subjects 4 and 9 are in the non-surgical radiation group and only have values for that column. The rest of the subjects are in the malignant tumor surgery and radiation and only have values in that column. For other missing values, certain tests were not performed at certain timepoints for some subjects.

Arm/Group Title	Non Surgical-Radiation Only	Malignant Tumor Surgery And Radiation
Arm/Group Description	Non-surgical candidates receive 72 up to 77.l4 Gy of radiation depending on the histology (72 Gy for osteosarcoma and chondrosarcoma and 77.4 Gy for chordoma Radiation: For surgical candidates, the standard treatment includes pre-operative radiation of 50.4 Gy, followed by a recovery period of approximately 4 to 5 weeks. After this surgery will take place. After approximately 6 weeks of recovery, to allow the surgical incision to heal, the patient is treated with another 19.8 Gy up to 27 Gy of radiation postoperatively depending on the final margin status (higher for gross residual disease) Non-surgical candidates receive 72 up to 77.14 Gy of radiation depending on the histology (72 Gy for osteosarcoma and chondrosarcoma and 77.4 Gy for chordoma)	The standard treatment includes pre-operative radiation of 50.4 Gy, followed by a recovery period of approximately 4 to 5 weeks. Surgery involves removing the malignant tumor in the sacrum in one piece, preferably with a cuff of normal tissue around the tumor. After approximately 6 weeks of recovery, the patient is treated with another 19.8 Gy up to 27 Gy of radiation postoperatively depending on the final margin status (higher for gross residual disease). If the wound is not healed or there is another medical reason to delay adjuvant radiation, then radiation may begin later. Radiation: For surgical candidates, the standard treatment includes pre-operative radiation of 50.4 Gy, followed by a recovery period of approximately 4 to 5 weeks. After this surgery will take place. After approximately 6 weeks of recovery, to allow the surgical incision to heal, the patient is treated with another 19.8 Gy up to 27 Gy of radiation postoperatively depending on the final margin status (higher for gross residual disease) Non-surgical candidates receive 72 up to 77.14 Gy of radiation depending on the histology (72 Gy for osteosarcoma and chondrosarcoma and 77.4 Gy for chordoma) Malignant Tumor Surgery: Surgery involves removing the malignant tumor in the sacrum in one piece, preferably with a cuff of normal tissue around the tumor
Measure Participants	2	7
Subject 2 (baseline)	3.823813
Subject 2 (5.5 weeks)	3.503794
Subject 2 (18.5 Weeks)	4.465143
Subject 2 (about 7 months)	4.226845
Subject 2 (about 10 months)	3.87936
Subject 3 (baseline)	4.235948
Subject 3 (5.5 weeks)	5.111555
Subject 4 (baseline)	2.951546
Subject 4 (3.5 weeks)	3.597596
Subject 4 (7 weeks)	3.22168
Subject 4 (about 8 months)	2.830882
Subject 6 (baseline)	5.482747
Subject 6 (5.5 weeks)	4.700929
Subject 6 (18.5 weeks)	6.675976
Subject 6 (about 7 months)	4.910525
Subject 6 (about 10 months)	3.99912
Subject 7 (baseline)	5.051881
Subject 7 (5.5 weeks)	4.211249
Subject 7 (18.5 weeks)	5.499551
Subject 7 (about 10 months)	3.725495
Subject 8 (baseline)	3.890646
Subject 8 (5.5 weeks)	4.353515
Subject 8 (18.5 weeks)	5.2026
Subject 8 (about 7 months)	5.025804
Subject 8 (about 10 months)	3.984603
Subject 9 (baseline)	2.461792
Subject 9 (3.5 weeks)	2.601314
Subject 9 (7 weeks)	3.056594
Subject 9 (about 5 months)	3.203289
Subject 9 (about 8 months)	2.194518
Subject 10 (baseline)	3.122802
Subject 10 (5.5 weeks)	2.776157
Subject 10 (18.5 weeks)	3.329006
Subject 10 (about 7 months)	2.496301
Subject 12 (baseline)	3.702653
Subject 12 (5.5 weeks)	3.986177
Subject 12 (18.5 weeks)	3.969791
Subject 12 (about 7 months)	3.615732

4. Secondary Outcome

Title	Serum Osteocalcin (OC)
Description	Indicator for Bone Formation, units reported in ng/mL
Time Frame	Non-surgical arm: baseline, 3.5 weeks, 7 weeks, ~5 months, ~8 months Surgical arm: baseline, 5.5 weeks, 18.5 weeks, ~7 months, ~10 months

Outcome Measure Data

Analysis Population Description

Subjects 4 and 9 are in the non-surgical radiation group and only have values for that column. The rest of the subjects are in the malignant tumor surgery and radiation and only have values in that column. For other missing values, certain tests were not performed at certain timepoints for some subjects.

Arm/Group Title	Non Surgical-Radiation Only	Malignant Tumor Surgery And Radiation
Arm/Group Description	Non-surgical candidates receive 72 up to 77.l4 Gy of radiation depending on the histology (72 Gy for osteosarcoma and chondrosarcoma and 77.4 Gy for chordoma Radiation: For surgical candidates, the standard treatment includes pre-operative radiation of 50.4 Gy, followed by a recovery period of approximately 4 to 5 weeks. After this surgery will take place. After approximately 6 weeks of recovery, to allow the surgical incision to heal, the patient is treated with another 19.8 Gy up to 27 Gy of radiation postoperatively depending on the final margin status (higher for gross residual disease) Non-surgical candidates receive 72 up to 77.14 Gy of radiation depending on the histology (72 Gy for osteosarcoma and chondrosarcoma and 77.4 Gy for chordoma)	The standard treatment includes pre-operative radiation of 50.4 Gy, followed by a recovery period of approximately 4 to 5 weeks. Surgery involves removing the malignant tumor in the sacrum in one piece, preferably with a cuff of normal tissue around the tumor. After approximately 6 weeks of recovery, the patient is treated with another 19.8 Gy up to 27 Gy of radiation postoperatively depending on the final margin status (higher for gross residual disease). If the wound is not healed or there is another medical reason to delay adjuvant radiation, then radiation may begin later. Radiation: For surgical candidates, the standard treatment includes pre-operative radiation of 50.4 Gy, followed by a recovery period of approximately 4 to 5 weeks. After this surgery will take place. After approximately 6 weeks of recovery, to allow the surgical incision to heal, the patient is treated with another 19.8 Gy up to 27 Gy of radiation postoperatively depending on the final margin status (higher for gross residual disease) Non-surgical candidates receive 72 up to 77.14 Gy of radiation depending on the histology (72 Gy for osteosarcoma and chondrosarcoma and 77.4 Gy for chordoma) Malignant Tumor Surgery: Surgery involves removing the malignant tumor in the sacrum in one piece, preferably with a cuff of normal tissue around the tumor
Measure Participants	2	7
Subject 2 (baseline)	14.304331
Subject 2 (5.5 weeks)	14.398441
Subject 2 (18.5 Weeks)	39.41674
Subject 2 (about 7 months)	24.231676
Subject 2 (about 10 months)	18.05678
Subject 3 (baseline)	31.395938
Subject 3 (5.5 weeks)	16.128416
Subject 4 (baseline)	7.70232
Subject 4 (3.5 weeks)	8.504592
Subject 4 (7 weeks)	10.025644
Subject 4 (about 8 months)	10.54423
Subject 6 (baseline)	10.954567
Subject 6 (5.5 weeks)	12.869497
Subject 6 (18.5 weeks)	13.061037
Subject 6 (about 7 months)	25.763047
Subject 6 (about 10 months)	18.419998
Subject 7 (baseline)	4.378182
Subject 7 (5.5 weeks)	10.369156
Subject 7 (18.5 weeks)	40.882969
Subject 7 (about 10 months)	28.262384
Subject 8 (baseline)	13.966
Subject 8 (5.5 weeks)	16.786965
Subject 8 (18.5 weeks)	32.353007
Subject 8 (about 7 months)	29.73705
Subject 8 (about 10 months)	26.099775
Subject 9 (baseline)	12.220099
Subject 9 (3.5 weeks)	12.368649
Subject 9 (7 weeks)	10.955072
Subject 9 (about 5 months)	11.167479
Subject 9 (about 8 months)	10.028165
Subject 10 (baseline)	12.321595
Subject 10 (5.5 weeks)	14.881427
Subject 10 (18.5 weeks)	19.861684
Subject 10 (about 7 months)	16.437832
Subject 12 (baseline)	17.549564
Subject 12 (5.5 weeks)	17.154958
Subject 12 (18.5 weeks)	11.480525
Subject 12 (about 7 months)	16.409198

5. Secondary Outcome

Title	Serum Type 1 Procollagen N-terminal (P1NP)
Description	Indicator for systemic metabolism that can affect bone health, units reported in pg/mL
Time Frame	Non-surgical arm: baseline, 3.5 weeks, 7 weeks, ~5 months, ~8 months Surgical arm: baseline, 5.5 weeks, 18.5 weeks, ~7 months, ~10 months

Outcome Measure Data

Analysis Population Description

Subjects 4 and 9 are in the non-surgical radiation group and only have values for that column. The rest of the subjects are in the malignant tumor surgery and radiation and only have values in that column. For other missing values, certain tests were not performed at certain timepoints for some subjects.

Arm/Group Title	Non Surgical-Radiation Only	Malignant Tumor Surgery And Radiation
Arm/Group Description	Non-surgical candidates receive 72 up to 77.l4 Gy of radiation depending on the histology (72 Gy for osteosarcoma and chondrosarcoma and 77.4 Gy for chordoma Radiation: For surgical candidates, the standard treatment includes pre-operative radiation of 50.4 Gy, followed by a recovery period of approximately 4 to 5 weeks. After this surgery will take place. After approximately 6 weeks of recovery, to allow the surgical incision to heal, the patient is treated with another 19.8 Gy up to 27 Gy of radiation postoperatively depending on the final margin status (higher for gross residual disease) Non-surgical candidates receive 72 up to 77.14 Gy of radiation depending on the histology (72 Gy for osteosarcoma and chondrosarcoma and 77.4 Gy for chordoma)	The standard treatment includes pre-operative radiation of 50.4 Gy, followed by a recovery period of approximately 4 to 5 weeks. Surgery involves removing the malignant tumor in the sacrum in one piece, preferably with a cuff of normal tissue around the tumor. After approximately 6 weeks of recovery, the patient is treated with another 19.8 Gy up to 27 Gy of radiation postoperatively depending on the final margin status (higher for gross residual disease). If the wound is not healed or there is another medical reason to delay adjuvant radiation, then radiation may begin later. Radiation: For surgical candidates, the standard treatment includes pre-operative radiation of 50.4 Gy, followed by a recovery period of approximately 4 to 5 weeks. After this surgery will take place. After approximately 6 weeks of recovery, to allow the surgical incision to heal, the patient is treated with another 19.8 Gy up to 27 Gy of radiation postoperatively depending on the final margin status (higher for gross residual disease) Non-surgical candidates receive 72 up to 77.14 Gy of radiation depending on the histology (72 Gy for osteosarcoma and chondrosarcoma and 77.4 Gy for chordoma) Malignant Tumor Surgery: Surgery involves removing the malignant tumor in the sacrum in one piece, preferably with a cuff of normal tissue around the tumor
Measure Participants	2	7
Subject 2 (baseline)	42.826123
Subject 2 (5.5 weeks)	34.128407
Subject 2 (18.5 Weeks)	123.860111
Subject 2 (about 7 months)	74.655436
Subject 2 (about 10 months)	68.966468
Subject 3 (baseline)	72.946381
Subject 3 (5.5 weeks)	44.08789
Subject 4 (baseline)	21.375865
Subject 4 (3.5 weeks)	28.095207
Subject 4 (7 weeks)	32.953174
Subject 4 (about 8 months)	43.37268
Subject 6 (baseline)	129.054174
Subject 6 (5.5 weeks)	83.031563
Subject 6 (18.5 weeks)	152.713648
Subject 6 (about 7 months)	186.103683
Subject 6 (about 10 months)	93.061044
Subject 7 (baseline)	13.875913
Subject 7 (5.5 weeks)	40.4564
Subject 7 (18.5 weeks)	135.28581
Subject 7 (about 10 months)	98.31769
Subject 8 (baseline)	39.183829
Subject 8 (5.5 weeks)	56.609907
Subject 8 (18.5 weeks)	219.86073
Subject 8 (about 7 months)	129.372101
Subject 8 (about 10 months)	99.637646
Subject 9 (baseline)	51.29302
Subject 9 (3.5 weeks)	38.642487
Subject 9 (7 weeks)	40.145122
Subject 9 (about 5 months)	42.945924
Subject 9 (about 8 months)	33.200638
Subject 10 (baseline)	53.568154
Subject 10 (5.5 weeks)	59.57128
Subject 10 (18.5 weeks)	114.083432
Subject 10 (about 7 months)	59.498204
Subject 12 (baseline)	47.539351
Subject 12 (5.5 weeks)	50.82762
Subject 12 (18.5 weeks)	72.878306
Subject 12 (about 7 months)	64.002627

6. Secondary Outcome

Title	Serum Phosphate (P)
Description	Indicators for systemic metabolism that can affect bone health, units reported in mg/dL
Time Frame	Non-surgical arm: baseline, 3.5 weeks, 7 weeks, ~5 months, ~8 months Surgical arm: baseline, 5.5 weeks, 18.5 weeks, ~7 months, ~10 months

Outcome Measure Data

Analysis Population Description

Subjects 4 and 9 are in the non-surgical radiation group and only have values for that column. The rest of the subjects are in the malignant tumor surgery and radiation and only have values in that column. For other missing values, certain tests were not performed at certain timepoints for some subjects.

Arm/Group Title	Non Surgical-Radiation Only	Malignant Tumor Surgery And Radiation
Arm/Group Description	Non-surgical candidates receive 72 up to 77.l4 Gy of radiation depending on the histology (72 Gy for osteosarcoma and chondrosarcoma and 77.4 Gy for chordoma Radiation: For surgical candidates, the standard treatment includes pre-operative radiation of 50.4 Gy, followed by a recovery period of approximately 4 to 5 weeks. After this surgery will take place. After approximately 6 weeks of recovery, to allow the surgical incision to heal, the patient is treated with another 19.8 Gy up to 27 Gy of radiation postoperatively depending on the final margin status (higher for gross residual disease) Non-surgical candidates receive 72 up to 77.14 Gy of radiation depending on the histology (72 Gy for osteosarcoma and chondrosarcoma and 77.4 Gy for chordoma)	The standard treatment includes pre-operative radiation of 50.4 Gy, followed by a recovery period of approximately 4 to 5 weeks. Surgery involves removing the malignant tumor in the sacrum in one piece, preferably with a cuff of normal tissue around the tumor. After approximately 6 weeks of recovery, the patient is treated with another 19.8 Gy up to 27 Gy of radiation postoperatively depending on the final margin status (higher for gross residual disease). If the wound is not healed or there is another medical reason to delay adjuvant radiation, then radiation may begin later. Radiation: For surgical candidates, the standard treatment includes pre-operative radiation of 50.4 Gy, followed by a recovery period of approximately 4 to 5 weeks. After this surgery will take place. After approximately 6 weeks of recovery, to allow the surgical incision to heal, the patient is treated with another 19.8 Gy up to 27 Gy of radiation postoperatively depending on the final margin status (higher for gross residual disease) Non-surgical candidates receive 72 up to 77.14 Gy of radiation depending on the histology (72 Gy for osteosarcoma and chondrosarcoma and 77.4 Gy for chordoma) Malignant Tumor Surgery: Surgery involves removing the malignant tumor in the sacrum in one piece, preferably with a cuff of normal tissue around the tumor
Measure Participants	2	7
Subject 2 (baseline)	3.9
Subject 2 (5.5 weeks)	3.5
Subject 2 (18.5 Weeks)	4.0
Subject 2 (about 7 months)	3.6
Subject 2 (about 10 months)	3.7
Subject 3 (baseline)	4.4
Subject 3 (5.5 weeks)	4.3
Subject 4 (baseline)	2.8
Subject 4 (3.5 weeks)	3.0
Subject 4 (7 weeks)	3.0
Subject 4 (about 8 months)	3.2
Subject 6 (baseline)	3.4
Subject 6 (5.5 weeks)	3.3
Subject 6 (18.5 weeks)	4.4
Subject 6 (about 7 months)	4.1
Subject 6 (about 10 months)	3.6
Subject 7 (baseline)	3.3
Subject 7 (5.5 weeks)	4.0
Subject 7 (18.5 weeks)	4.9
Subject 7 (about 10 months)	4.0
Subject 8 (baseline)	3.3
Subject 8 (5.5 weeks)	3.3
Subject 8 (18.5 weeks)	3.5
Subject 8 (about 7 months)	3.7
Subject 8 (about 10 months)	3.3
Subject 9 (baseline)	4.3
Subject 9 (3.5 weeks)	4.0
Subject 9 (7 weeks)	4.7
Subject 9 (about 5 months)	4.2
Subject 9 (about 8 months)	3.4
Subject 10 (baseline)	2.4
Subject 10 (5.5 weeks)	4.0
Subject 10 (18.5 weeks)	3.5
Subject 10 (about 7 months)	2.2
Subject 12 (baseline)	4.2
Subject 12 (5.5 weeks)	3.7
Subject 12 (18.5 weeks)	3.4
Subject 12 (about 7 months)	3.4

7. Secondary Outcome

Title	Serum 25-hydroxycalciferol Vit D (25-OH VitD)
Description	Indicators for systemic metabolism that can affect bone health, units reported in nmol/L
Time Frame	Non-surgical arm: baseline, 3.5 weeks, 7 weeks, ~5 months, ~8 months Surgical arm: baseline, 5.5 weeks, 18.5 weeks, ~7 months, ~10 months

Outcome Measure Data

Analysis Population Description

Subjects 4 and 9 are in the non-surgical radiation group and only have values for that column. The rest of the subjects are in the malignant tumor surgery and radiation and only have values in that column. For other missing values, certain tests were not performed at certain timepoints for some subjects.

Arm/Group Title	Non Surgical-Radiation Only	Malignant Tumor Surgery And Radiation
Arm/Group Description	Non-surgical candidates receive 72 up to 77.l4 Gy of radiation depending on the histology (72 Gy for osteosarcoma and chondrosarcoma and 77.4 Gy for chordoma Radiation: For surgical candidates, the standard treatment includes pre-operative radiation of 50.4 Gy, followed by a recovery period of approximately 4 to 5 weeks. After this surgery will take place. After approximately 6 weeks of recovery, to allow the surgical incision to heal, the patient is treated with another 19.8 Gy up to 27 Gy of radiation postoperatively depending on the final margin status (higher for gross residual disease) Non-surgical candidates receive 72 up to 77.14 Gy of radiation depending on the histology (72 Gy for osteosarcoma and chondrosarcoma and 77.4 Gy for chordoma)	The standard treatment includes pre-operative radiation of 50.4 Gy, followed by a recovery period of approximately 4 to 5 weeks. Surgery involves removing the malignant tumor in the sacrum in one piece, preferably with a cuff of normal tissue around the tumor. After approximately 6 weeks of recovery, the patient is treated with another 19.8 Gy up to 27 Gy of radiation postoperatively depending on the final margin status (higher for gross residual disease). If the wound is not healed or there is another medical reason to delay adjuvant radiation, then radiation may begin later. Radiation: For surgical candidates, the standard treatment includes pre-operative radiation of 50.4 Gy, followed by a recovery period of approximately 4 to 5 weeks. After this surgery will take place. After approximately 6 weeks of recovery, to allow the surgical incision to heal, the patient is treated with another 19.8 Gy up to 27 Gy of radiation postoperatively depending on the final margin status (higher for gross residual disease) Non-surgical candidates receive 72 up to 77.14 Gy of radiation depending on the histology (72 Gy for osteosarcoma and chondrosarcoma and 77.4 Gy for chordoma) Malignant Tumor Surgery: Surgery involves removing the malignant tumor in the sacrum in one piece, preferably with a cuff of normal tissue around the tumor
Measure Participants	2	7
Subject 2 (baseline)	36.065991
Subject 2 (5.5 weeks)	32.073769
Subject 2 (18.5 Weeks)	31.302671
Subject 2 (about 7 months)	36.77789
Subject 2 (about 10 months)	33.419347
Subject 3 (baseline)	17.038722
Subject 3 (5.5 weeks)	12.739664
Subject 4 (baseline)	60.483526
Subject 4 (3.5 weeks)	50.942045
Subject 4 (7 weeks)	38.703589
Subject 4 (about 8 months)	62.317379
Subject 6 (baseline)	36.051246
Subject 6 (5.5 weeks)	35.309918
Subject 6 (18.5 weeks)	36.748899
Subject 6 (about 7 months)	32.918895
Subject 6 (about 10 months)	36.262804
Subject 7 (baseline)	17.740625
Subject 7 (5.5 weeks)	17.258697
Subject 7 (18.5 weeks)	27.862934
Subject 7 (about 10 months)	20.845497
Subject 8 (baseline)	23.596514
Subject 8 (5.5 weeks)	22.190329
Subject 8 (18.5 weeks)	27.355142
Subject 8 (about 7 months)	29.649107
Subject 8 (about 10 months)	25.399281
Subject 9 (baseline)	39.515148
Subject 9 (3.5 weeks)	39.281166
Subject 9 (7 weeks)	40.21479
Subject 9 (about 5 months)	41.193903
Subject 9 (about 8 months)	47.316427
Subject 10 (baseline)	30.093394
Subject 10 (5.5 weeks)	30.491835
Subject 10 (18.5 weeks)	27.330808
Subject 10 (about 7 months)	28.958284
Subject 12 (baseline)	18.366566
Subject 12 (5.5 weeks)	25.333837
Subject 12 (18.5 weeks)	31.425202
Subject 12 (about 7 months)	32.557435

8. Secondary Outcome

Title	Mineral Apposition Rate (MAR)
Description	Tetracycline quadruple labeling method will be used and the unit of measure will be um/day
Time Frame	Only surgical arm: The months after biopsies are taken during surgery (surgery is during week 4 and 5). These measurements will be done in batches so timeframe isn't clear.

Outcome Measure Data

Analysis Population Description

B = before radiation, A = after radiation. For missing values, certain tests were not performed at certain timepoints for some subjects.

Arm/Group Title	Non Surgical-Radiation Only	Malignant Tumor Surgery And Radiation
Arm/Group Description	Non-surgical candidates receive 72 up to 77.l4 Gy of radiation depending on the histology (72 Gy for osteosarcoma and chondrosarcoma and 77.4 Gy for chordoma Radiation: For surgical candidates, the standard treatment includes pre-operative radiation of 50.4 Gy, followed by a recovery period of approximately 4 to 5 weeks. After this surgery will take place. After approximately 6 weeks of recovery, to allow the surgical incision to heal, the patient is treated with another 19.8 Gy up to 27 Gy of radiation postoperatively depending on the final margin status (higher for gross residual disease) Non-surgical candidates receive 72 up to 77.14 Gy of radiation depending on the histology (72 Gy for osteosarcoma and chondrosarcoma and 77.4 Gy for chordoma)	The standard treatment includes pre-operative radiation of 50.4 Gy, followed by a recovery period of approximately 4 to 5 weeks. Surgery involves removing the malignant tumor in the sacrum in one piece, preferably with a cuff of normal tissue around the tumor. After approximately 6 weeks of recovery, the patient is treated with another 19.8 Gy up to 27 Gy of radiation postoperatively depending on the final margin status (higher for gross residual disease). If the wound is not healed or there is another medical reason to delay adjuvant radiation, then radiation may begin later. Radiation: For surgical candidates, the standard treatment includes pre-operative radiation of 50.4 Gy, followed by a recovery period of approximately 4 to 5 weeks. After this surgery will take place. After approximately 6 weeks of recovery, to allow the surgical incision to heal, the patient is treated with another 19.8 Gy up to 27 Gy of radiation postoperatively depending on the final margin status (higher for gross residual disease) Non-surgical candidates receive 72 up to 77.14 Gy of radiation depending on the histology (72 Gy for osteosarcoma and chondrosarcoma and 77.4 Gy for chordoma) Malignant Tumor Surgery: Surgery involves removing the malignant tumor in the sacrum in one piece, preferably with a cuff of normal tissue around the tumor
Measure Participants	0	7
Subject 2 (Iliac Crest, Cancellous, B)	0.64
Subject 2 (iliac Crest, Cancellous, A)	0.66
Subject 2 (Iliac Crest, Endocortical, B)	0.55
Subject 2 (Iliac Crest, Endocortical, A)	0.71
Subject 2 (Iliac Crest, Intracortical, B)	0.72
Subject 2 (Iliac Crest, Intracortical, A)	0.44
Subject 2 (Sacrum, Cancellous, B)	0.58
Subject 2 (Sacrum, Cancellous, A)	0.45
Subject 2 (Sacrum, Endocortical, B)	0.70
Subject 2 (Sacrum, Intracortical, B)	0.47
Subject 2 (Sacrum, Periosteal, B)	1.50
Subject 2 (Sacrum, Periosteal, A)	0.98
Subject 3 (Iliac Crest, Cancellous, B)	0.64
Subject 3 (Iliac Crest, Cancellous, A)	0.54
Subject 3 (Iliac Crest, Endocortical, B)	0.53
Subject 3 (Iliac Crest, Endocortical, A)	0.46
Subject 3 (Iliac Crest, Intracortical, B)	0.64
Subject 3 (Iliac Crest, Intracortical, A)	0.59
Subject 3 (Sacrum, Cancellous, B)	0.62
Subject 3 (Sacrum, Cancellous, A)	0.34
Subject 6 (Iliac Crest, Cancellous, B)	0.51
Subject 6 (Iliac Crest, Cancellous, A)	0.40
Subject 6 (Iliac Crest, Endocortical, B)	0.51
Subject 6 (Iliac Crest, Endocortical, A)	0.43
Subject 6 (Iliac Crest, Intracortical, B)	1.12
Subject 6 (Iliac Crest, Intracortical, A)	0.50
Subject 6 (Sacrum, Cancellous, B)	0.51
Subject 6 (Sacrum, Cancellous, A)	0.37
Subject 6 (Sacrum, Endocortical, B)	0.55
Subject 6 (Sacrum, Endocortical, A)	0.18
Subject 7 (Iliac Crest, Cancellous, B)	0.65
Subject 7 (Iliac Crest, Cancellous, A)	0.72
Subject 7 (Iliac Crest, Endocortical, A)	0.48
Subject 7 (Iliac Crest, Intracortical, B)	1.20
Subject 7 (Iliac Crest, Periosteal, B)	0.33
Subject 7 (Iliac Crest, Periosteal, A)	0.47
Subject 7 (Sacrum, Cancellous, B)	0.69
Subject 7 (Sacrum, Cancellous, A)	0.59
Subject 7 (Sacrum, Endocortical, B)	0.41
Subject 7 (Sacrum, Endocortical, A)	0.76
Subject 7 (Sacrum, Intracortical, B)	0.92
Subject 7 (Sacrum, Intracortical, A)	0.68
Subject 8 (Iliac Crest, Cancellous, B)	0.62
Subject 8 (Iliac Crest, Cancellous, A)	0.43
Subject 8 (Iliac Crest, Endocortical, B)	0.51
Subject 8 (Iliac Crest, Endocortical, A)	0.33
Subject 8 (Iliac Crest, Intracortical, B)	1.83
Subject 8 (Iliac Crest, Intracortical, A)	0.73
Subject 8 (Sacrum, Cancellous, B)	0.56
Subject 10 (Iliac Crest, Cancellous, B)	0.60
Subject 10 (Iliac Crest, Cancellous, A)	0.40
Subject 10 (Iliac Crest, Endocortical, B)	0.42
Subject 10 (Iliac Crest, Endocortical, A)	0.41
Subject 10 (Iliac Crest, Intracortical, B)	0.49
Subject 10 (Iliac Crest, Intracortical, A)	0.53
Subject 10 (Sacrum, Cancellous, B)	0.50
Subject 10 (Sacrum, Cancellous, A)	0.49
Subject 10 (Sacrum, Endocortical, B)	0.44
Subject 10 (Sacrum, Intracortical, B)	0.60
Subject 12 (Iliac Crest, Cancellous, B)	0.53
Subject 12 (Iliac Crest, Endocortical, B)	0.48
Subject 12 (Iliac Crest, Intracortical, B)	0.96
Subject 12 (Sacrum, Cancellous, B)	0.47
Subject 12 (Sacrum, Endocortical, B)	0.50
Subject 12 (Sacrum, Intracortical, B)	1.31

9. Secondary Outcome

Title	Bone Formation Rate (BFR/BS)
Description	Tetracycline quadruple labeling method will be used and the unit of measure will be mm3/mm2/year
Time Frame	Only surgical arm: The months after biopsies are taken during surgery (surgery is during week 4 and 5). These measurements will be done in batches so timeframe isn't clear.

Outcome Measure Data

Analysis Population Description

B = before radiation, A = after radiation. For missing values, certain tests were not performed at certain timepoints for some subjects.

Arm/Group Title	Non Surgical-Radiation Only	Malignant Tumor Surgery And Radiation
Arm/Group Description	Non-surgical candidates receive 72 up to 77.l4 Gy of radiation depending on the histology (72 Gy for osteosarcoma and chondrosarcoma and 77.4 Gy for chordoma Radiation: For surgical candidates, the standard treatment includes pre-operative radiation of 50.4 Gy, followed by a recovery period of approximately 4 to 5 weeks. After this surgery will take place. After approximately 6 weeks of recovery, to allow the surgical incision to heal, the patient is treated with another 19.8 Gy up to 27 Gy of radiation postoperatively depending on the final margin status (higher for gross residual disease) Non-surgical candidates receive 72 up to 77.14 Gy of radiation depending on the histology (72 Gy for osteosarcoma and chondrosarcoma and 77.4 Gy for chordoma)	The standard treatment includes pre-operative radiation of 50.4 Gy, followed by a recovery period of approximately 4 to 5 weeks. Surgery involves removing the malignant tumor in the sacrum in one piece, preferably with a cuff of normal tissue around the tumor. After approximately 6 weeks of recovery, the patient is treated with another 19.8 Gy up to 27 Gy of radiation postoperatively depending on the final margin status (higher for gross residual disease). If the wound is not healed or there is another medical reason to delay adjuvant radiation, then radiation may begin later. Radiation: For surgical candidates, the standard treatment includes pre-operative radiation of 50.4 Gy, followed by a recovery period of approximately 4 to 5 weeks. After this surgery will take place. After approximately 6 weeks of recovery, to allow the surgical incision to heal, the patient is treated with another 19.8 Gy up to 27 Gy of radiation postoperatively depending on the final margin status (higher for gross residual disease) Non-surgical candidates receive 72 up to 77.14 Gy of radiation depending on the histology (72 Gy for osteosarcoma and chondrosarcoma and 77.4 Gy for chordoma) Malignant Tumor Surgery: Surgery involves removing the malignant tumor in the sacrum in one piece, preferably with a cuff of normal tissue around the tumor
Measure Participants	0	7
Subject 2 (Iliac Crest, Cancellous, B)	0.003
Subject 2 (iliac Crest, Cancellous, A)	0.003
Subject 2 (Iliac Crest, Endocortical, B)	0.013
Subject 2 (Iliac Crest, Endocortical, A)	0.013
Subject 2 (Iliac Crest, Intracortical, B)	0.014
Subject 2 (Iliac Crest, Intracortical, A)	0.013
Subject 2 (Iliac Crest, Periosteal, B)	0.000
Subject 2 (Iliac Crest, Periosteal, A)	0.000
Subject 2 (Sacrum, Cancellous, B)	0.007
Subject 2 (Sacrum, Cancellous, A)	0.001
Subject 2 (Sacrum, Endocortical, B)	0.052
Subject 2 (Sacrum, Intracortical, B)	0.053
Subject 2 (Sacrum, Intracortical, A)	0.000
Subject 2 (Sacrum, Periosteal, B)	0.012
Subject 2 (Sacrum, Periosteal, A)	0.004
Subject 3 (Iliac Crest, Cancellous, B)	0.016
Subject 3 (Iliac Crest, Cancellous, A)	0.012
Subject 3 (Iliac Crest, Endocortical, B)	0.021
Subject 3 (Iliac Crest, Endocortical, A)	0.009
Subject 3 (Iliac Crest, Intracortical, B)	0.047
Subject 3 (Iliac Crest, Intracortical, A)	0.032
Subject 3 (Iliac Crest, Periosteal, B)	0.000
Subject 3 (Iliac Crest, Periosteal, A)	0.000
Subject 3 (Sacrum, Cancellous, B)	0.009
Subject 3 (Sacrum, Cancellous, A)	0.001
Subject 6 (Iliac Crest, Cancellous, B)	0.005
Subject 6 (Iliac Crest, Cancellous, A)	0.006
Subject 6 (Iliac Crest, Endocortical, B)	0.019
Subject 6 (Iliac Crest, Endocortical, A)	0.024
Subject 6 (Iliac Crest, Intracortical, B)	0.029
Subject 6 (Iliac Crest, Intracortical, A)	0.041
Subject 6 (Iliac Crest, Periosteal, B)	0.000
Subject 6 (Iliac Crest, Periosteal, A)	0.000
Subject 6 (Sacrum, Cancellous, B)	0.003
Subject 6 (Sacrum, Cancellous, A)	0.001
Subject 6 (Sacrum, Endocortical, B)	0.010
Subject 6 (Sacrum, Endocortical, A)	0.001
Subject 6 (Sacrum, Intracortical, B)	0.000
Subject 6 (Sacrum, Intracortical, A)	0.000
Subject 6 (Sacrum, Periosteal, B)	0.000
Subject 6 (Sacrum, Periosteal, A)	0.000
Subject 7 (Iliac Crest, Cancellous, B)	0.012
Subject 7 (Iliac Crest, Cancellous, A)	0.031
Subject 7 (Iliac Crest, Endocortical, A)	0.004
Subject 7 (Iliac Crest, Intracortical, B)	0.057
Subject 7 (Iliac Crest, Periosteal, B)	0.007
Subject 7 (Iliac Crest, Periosteal, A)	0.036
Subject 7 (Sacrum, Cancellous, B)	0.011
Subject 7 (Sacrum, Cancellous, A)	0.007
Subject 7 (Sacrum, Endocortical, B)	0.004
Subject 7 (Sacrum, Endocortical, A)	0.007
Subject 7 (Sacrum, Intracortical, B)	0.004
Subject 7 (Sacrum, Intracortical, A)	0.002
Subject 7 (Sacrum, Periosteal, B)	0.000
Subject 7 (Sacrum, Periosteal, A)	0.000
Subject 8 (Iliac Crest, Cancellous, B)	0.004
Subject 8 (Iliac Crest, Cancellous, A)	0.001
Subject 8 (Iliac Crest, Endocortical, B)	0.016
Subject 8 (Iliac Crest, Endocortical, A)	0.007
Subject 8 (Iliac Crest, Intracortical, B)	0.039
Subject 8 (Iliac Crest, Intracortical, A)	0.035
Subject 8 (Iliac Crest, Periosteal, B)	0.000
Subject 8 (Iliac Crest, Periosteal, A)	0.000
Subject 8 (Sacrum, Cancellous, B)	0.005
Subject 10 (Iliac Crest, Cancellous, B)	0.022
Subject 10 (Iliac Crest, Cancellous, A)	0.016
Subject 10 (Iliac Crest, Endocortical, B)	0.022
Subject 10 (Iliac Crest, Endocortical, A)	0.030
Subject 10 (Iliac Crest, Intracortical, B)	0.023
Subject 10 (Iliac Crest, Intracortical, A)	0.032
Subject 10 (Iliac Crest, Periosteal, B)	0.000
Subject 10 (Iliac Crest, Periosteal, A)	0.000
Subject 10 (Sacrum, Cancellous, B)	0.003
Subject 10 (Sacrum, Cancellous, A)	0.001
Subject 10 (Sacrum, Endocortical, B)	0.002
Subject 10 (Sacrum, Intracortical, B)	0.013
Subject 10 (Sacrum, Periosteal, B)	0.000
Subject 10 (Sacrum, Periosteal, A)	0.000
Subject 12 (Iliac Crest, Cancellous, B)	0.018
Subject 12 (Iliac Crest, Endocortical, B)	0.028
Subject 12 (Iliac Crest, Intracortical, B)	0.017
Subject 12 (Sacrum, Cancellous, B)	0.005
Subject 12 (Sacrum, Endocortical, B)	0.017
Subject 12 (Sacrum, Intracortical, B)	0.063
Subject 12 (Sacrum, Periosteal, B)	0.000

10. Secondary Outcome

Title	Mineralization Lag Time (Mlt)
Description	Tetracycline quadruple labeling method will be used and the unit of measure will be days
Time Frame	Only surgical arm: The months after biopsies are taken during surgery (surgery is during week 4 and 5). These measurements will be done in batches so timeframe isn't clear.

Outcome Measure Data

Analysis Population Description

A = after radiation. No periosteal data for any subject. For other missing values, certain tests were not performed at certain timepoints for some subjects.

Arm/Group Title	Non Surgical-Radiation Only	Malignant Tumor Surgery And Radiation
Arm/Group Description	Non-surgical candidates receive 72 up to 77.l4 Gy of radiation depending on the histology (72 Gy for osteosarcoma and chondrosarcoma and 77.4 Gy for chordoma Radiation: For surgical candidates, the standard treatment includes pre-operative radiation of 50.4 Gy, followed by a recovery period of approximately 4 to 5 weeks. After this surgery will take place. After approximately 6 weeks of recovery, to allow the surgical incision to heal, the patient is treated with another 19.8 Gy up to 27 Gy of radiation postoperatively depending on the final margin status (higher for gross residual disease) Non-surgical candidates receive 72 up to 77.14 Gy of radiation depending on the histology (72 Gy for osteosarcoma and chondrosarcoma and 77.4 Gy for chordoma)	The standard treatment includes pre-operative radiation of 50.4 Gy, followed by a recovery period of approximately 4 to 5 weeks. Surgery involves removing the malignant tumor in the sacrum in one piece, preferably with a cuff of normal tissue around the tumor. After approximately 6 weeks of recovery, the patient is treated with another 19.8 Gy up to 27 Gy of radiation postoperatively depending on the final margin status (higher for gross residual disease). If the wound is not healed or there is another medical reason to delay adjuvant radiation, then radiation may begin later. Radiation: For surgical candidates, the standard treatment includes pre-operative radiation of 50.4 Gy, followed by a recovery period of approximately 4 to 5 weeks. After this surgery will take place. After approximately 6 weeks of recovery, to allow the surgical incision to heal, the patient is treated with another 19.8 Gy up to 27 Gy of radiation postoperatively depending on the final margin status (higher for gross residual disease) Non-surgical candidates receive 72 up to 77.14 Gy of radiation depending on the histology (72 Gy for osteosarcoma and chondrosarcoma and 77.4 Gy for chordoma) Malignant Tumor Surgery: Surgery involves removing the malignant tumor in the sacrum in one piece, preferably with a cuff of normal tissue around the tumor
Measure Participants	0	7
Subject 2 (iliac Crest, Cancellous, A)	40.77
Subject 2 (Iliac Crest, Endocortical, A)	15.47
Subject 2 (Iliac Crest, Intracortical, A)	12.56
Subject 2 (Sacrum, Cancellous, A)	68.10
Subject 3 (Iliac Crest, Cancellous, A)	21.70
Subject 3 (Iliac Crest, Endocortical, A)	41.88
Subject 3 (Iliac Crest, Intracortical, A)	20.33
Subject 3 (Sacrum, Cancellous, A)	7.45
Subject 6 (Iliac Crest, Cancellous, A)	24.98
Subject 6 (Iliac Crest, Endocortical, A)	13.31
Subject 6 (Iliac Crest, Intracortical, A)	16.36
Subject 6 (Sacrum, Cancellous, A)	110.51
Subject 6 (Sacrum, Endocortical, A)	40.28
Subject 7 (Iliac Crest, Cancellous, A)	16.28
Subject 7 (Iliac Crest, Endocortical, A)	15.49
Subject 7 (Sacrum, Cancellous, A)	34.10
Subject 7 (Sacrum, Endocortical, A)	37.18
Subject 7 (Sacrum, Intracortical, A)	87.15
Subject 8 (Iliac Crest, Cancellous, A)	3.11
Subject 8 (Iliac Crest, Endocortical, A)	10.72
Subject 8 (Iliac Crest, Intracortical, A)	8.15
Subject 10 (Iliac Crest, Cancellous, A)	63.18
Subject 10 (Iliac Crest, Endocortical, A)	34.23
Subject 10 (Iliac Crest, Intracortical, A)	26.65
Subject 10 (Sacrum, Cancellous, A)	142.08

11. Secondary Outcome

Title	Osteoblast Number (N.Ob/BPm)
Description	Immunohistochemistry staining methods will be used and the unit of measure will be mm^-1
Time Frame	Only surgical arm: The weeks after biopsies are taken during surgery (surgery is during week 4 and 5).

Outcome Measure Data

Analysis Population Description

No biopsy data for subjects 10 and 12.

Arm/Group Title	Non Surgical-Radiation Only	Malignant Tumor Surgery And Radiation
Arm/Group Description	Non-surgical candidates receive 72 up to 77.l4 Gy of radiation depending on the histology (72 Gy for osteosarcoma and chondrosarcoma and 77.4 Gy for chordoma Radiation: For surgical candidates, the standard treatment includes pre-operative radiation of 50.4 Gy, followed by a recovery period of approximately 4 to 5 weeks. After this surgery will take place. After approximately 6 weeks of recovery, to allow the surgical incision to heal, the patient is treated with another 19.8 Gy up to 27 Gy of radiation postoperatively depending on the final margin status (higher for gross residual disease) Non-surgical candidates receive 72 up to 77.14 Gy of radiation depending on the histology (72 Gy for osteosarcoma and chondrosarcoma and 77.4 Gy for chordoma)	The standard treatment includes pre-operative radiation of 50.4 Gy, followed by a recovery period of approximately 4 to 5 weeks. Surgery involves removing the malignant tumor in the sacrum in one piece, preferably with a cuff of normal tissue around the tumor. After approximately 6 weeks of recovery, the patient is treated with another 19.8 Gy up to 27 Gy of radiation postoperatively depending on the final margin status (higher for gross residual disease). If the wound is not healed or there is another medical reason to delay adjuvant radiation, then radiation may begin later. Radiation: For surgical candidates, the standard treatment includes pre-operative radiation of 50.4 Gy, followed by a recovery period of approximately 4 to 5 weeks. After this surgery will take place. After approximately 6 weeks of recovery, to allow the surgical incision to heal, the patient is treated with another 19.8 Gy up to 27 Gy of radiation postoperatively depending on the final margin status (higher for gross residual disease) Non-surgical candidates receive 72 up to 77.14 Gy of radiation depending on the histology (72 Gy for osteosarcoma and chondrosarcoma and 77.4 Gy for chordoma) Malignant Tumor Surgery: Surgery involves removing the malignant tumor in the sacrum in one piece, preferably with a cuff of normal tissue around the tumor
Measure Participants	0	7
Subject 2 (week 5)	0.26
Subject 2 (week 6)	0.05
Subject 3 (week 5)	1.25
Subject 3 (week 6)	0.05
Subject 6 (week 5)	1.04
Subject 6 (week 6)	0.19
Subject 7 (week 5)	6.23
Subject 7 (week 6)	1.89
Subject 8 (week 5)	0.05
Subject 8 (week 6)	0.16

12. Secondary Outcome

Title	Osteoblast Surface (Ob. S/BS)
Description	Immunohistochemistry staining methods will be used and the unit of measure will be mm^-1
Time Frame	Only surgical arm: The weeks after biopsies are taken during surgery (surgery is during week 4 and 5).

Outcome Measure Data

Analysis Population Description

No biopsy data for subjects 10 and 12.

Arm/Group Title	Non Surgical-Radiation Only	Malignant Tumor Surgery And Radiation
Arm/Group Description	Non-surgical candidates receive 72 up to 77.l4 Gy of radiation depending on the histology (72 Gy for osteosarcoma and chondrosarcoma and 77.4 Gy for chordoma Radiation: For surgical candidates, the standard treatment includes pre-operative radiation of 50.4 Gy, followed by a recovery period of approximately 4 to 5 weeks. After this surgery will take place. After approximately 6 weeks of recovery, to allow the surgical incision to heal, the patient is treated with another 19.8 Gy up to 27 Gy of radiation postoperatively depending on the final margin status (higher for gross residual disease) Non-surgical candidates receive 72 up to 77.14 Gy of radiation depending on the histology (72 Gy for osteosarcoma and chondrosarcoma and 77.4 Gy for chordoma)	The standard treatment includes pre-operative radiation of 50.4 Gy, followed by a recovery period of approximately 4 to 5 weeks. Surgery involves removing the malignant tumor in the sacrum in one piece, preferably with a cuff of normal tissue around the tumor. After approximately 6 weeks of recovery, the patient is treated with another 19.8 Gy up to 27 Gy of radiation postoperatively depending on the final margin status (higher for gross residual disease). If the wound is not healed or there is another medical reason to delay adjuvant radiation, then radiation may begin later. Radiation: For surgical candidates, the standard treatment includes pre-operative radiation of 50.4 Gy, followed by a recovery period of approximately 4 to 5 weeks. After this surgery will take place. After approximately 6 weeks of recovery, to allow the surgical incision to heal, the patient is treated with another 19.8 Gy up to 27 Gy of radiation postoperatively depending on the final margin status (higher for gross residual disease) Non-surgical candidates receive 72 up to 77.14 Gy of radiation depending on the histology (72 Gy for osteosarcoma and chondrosarcoma and 77.4 Gy for chordoma) Malignant Tumor Surgery: Surgery involves removing the malignant tumor in the sacrum in one piece, preferably with a cuff of normal tissue around the tumor
Measure Participants	0	7
Subject 2 (week 5)	0.58
Subject 2 (week 6)	0.10
Subject 3 (week 5)	2.38
Subject 3 (week 6)	0.07
Subject 6 (week 5)	1.63
Subject 6 (week 6)	0.29
Subject 7 (week 5)	9.07
Subject 7 (week 6)	2.71
Subject 8 (week 5)	0.05
Subject 8 (week 6)	0.23

13. Secondary Outcome

Title	Osteoclast Number (N.Oc/BPm)
Description	Immunohistochemistry staining methods will be used and the unit of measure will be mm^-1
Time Frame	Only surgical arm: The weeks after biopsies are taken during surgery (surgery is during week 4 and 5).

Outcome Measure Data

Analysis Population Description

No biopsy data for subjects 10 and 12.

Arm/Group Title	Non Surgical-Radiation Only	Malignant Tumor Surgery And Radiation
Arm/Group Description	Non-surgical candidates receive 72 up to 77.l4 Gy of radiation depending on the histology (72 Gy for osteosarcoma and chondrosarcoma and 77.4 Gy for chordoma Radiation: For surgical candidates, the standard treatment includes pre-operative radiation of 50.4 Gy, followed by a recovery period of approximately 4 to 5 weeks. After this surgery will take place. After approximately 6 weeks of recovery, to allow the surgical incision to heal, the patient is treated with another 19.8 Gy up to 27 Gy of radiation postoperatively depending on the final margin status (higher for gross residual disease) Non-surgical candidates receive 72 up to 77.14 Gy of radiation depending on the histology (72 Gy for osteosarcoma and chondrosarcoma and 77.4 Gy for chordoma)	The standard treatment includes pre-operative radiation of 50.4 Gy, followed by a recovery period of approximately 4 to 5 weeks. Surgery involves removing the malignant tumor in the sacrum in one piece, preferably with a cuff of normal tissue around the tumor. After approximately 6 weeks of recovery, the patient is treated with another 19.8 Gy up to 27 Gy of radiation postoperatively depending on the final margin status (higher for gross residual disease). If the wound is not healed or there is another medical reason to delay adjuvant radiation, then radiation may begin later. Radiation: For surgical candidates, the standard treatment includes pre-operative radiation of 50.4 Gy, followed by a recovery period of approximately 4 to 5 weeks. After this surgery will take place. After approximately 6 weeks of recovery, to allow the surgical incision to heal, the patient is treated with another 19.8 Gy up to 27 Gy of radiation postoperatively depending on the final margin status (higher for gross residual disease) Non-surgical candidates receive 72 up to 77.14 Gy of radiation depending on the histology (72 Gy for osteosarcoma and chondrosarcoma and 77.4 Gy for chordoma) Malignant Tumor Surgery: Surgery involves removing the malignant tumor in the sacrum in one piece, preferably with a cuff of normal tissue around the tumor
Measure Participants	0	7
Subject 2 (week 5)	0.02
Subject 2 (week 6)	0.00
Subject 3 (week 5)	0.03
Subject 3 (week 6)	0.01
Subject 6 (week 5)	0.08
Subject 6 (week 6)	0.02
Subject 7 (week 5)	0.10
Subject 7 (week 6)	0.31
Subject 8 (week 5)	0
Subject 8 (week 6)	0.07

14. Secondary Outcome

Title	Osteoclast Surface (Oc.S/BS)
Description	Immunohistochemistry staining methods will be used and the unit of measure will be mm^-1
Time Frame	Only surgical arm: The weeks after biopsies are taken during surgery (surgery is during week 4 and 5).

Outcome Measure Data

Analysis Population Description

No biopsy data for subjects 10 and 12.

Arm/Group Title	Non Surgical-Radiation Only	Malignant Tumor Surgery And Radiation
Arm/Group Description	Non-surgical candidates receive 72 up to 77.l4 Gy of radiation depending on the histology (72 Gy for osteosarcoma and chondrosarcoma and 77.4 Gy for chordoma Radiation: For surgical candidates, the standard treatment includes pre-operative radiation of 50.4 Gy, followed by a recovery period of approximately 4 to 5 weeks. After this surgery will take place. After approximately 6 weeks of recovery, to allow the surgical incision to heal, the patient is treated with another 19.8 Gy up to 27 Gy of radiation postoperatively depending on the final margin status (higher for gross residual disease) Non-surgical candidates receive 72 up to 77.14 Gy of radiation depending on the histology (72 Gy for osteosarcoma and chondrosarcoma and 77.4 Gy for chordoma)	The standard treatment includes pre-operative radiation of 50.4 Gy, followed by a recovery period of approximately 4 to 5 weeks. Surgery involves removing the malignant tumor in the sacrum in one piece, preferably with a cuff of normal tissue around the tumor. After approximately 6 weeks of recovery, the patient is treated with another 19.8 Gy up to 27 Gy of radiation postoperatively depending on the final margin status (higher for gross residual disease). If the wound is not healed or there is another medical reason to delay adjuvant radiation, then radiation may begin later. Radiation: For surgical candidates, the standard treatment includes pre-operative radiation of 50.4 Gy, followed by a recovery period of approximately 4 to 5 weeks. After this surgery will take place. After approximately 6 weeks of recovery, to allow the surgical incision to heal, the patient is treated with another 19.8 Gy up to 27 Gy of radiation postoperatively depending on the final margin status (higher for gross residual disease) Non-surgical candidates receive 72 up to 77.14 Gy of radiation depending on the histology (72 Gy for osteosarcoma and chondrosarcoma and 77.4 Gy for chordoma) Malignant Tumor Surgery: Surgery involves removing the malignant tumor in the sacrum in one piece, preferably with a cuff of normal tissue around the tumor
Measure Participants	0	7
Subject 2 (week 5)	0.12
Subject 2 (week 6)	0.00
Subject 3 (week 5)	0.11
Subject 3 (week 6)	0.02
Subject 6 (week 5)	0.36
Subject 6 (week 6)	0.12
Subject 7 (week 5)	0.44
Subject 7 (week 6)	1.27
Subject 8 (week 5)	0.00
Subject 8 (week 6)	0.29

Adverse Events

Time Frame	From first dose of study treatment to final study date per patient, approximately 10 months.
Arm/Group Title	Non Surgical-Radiation Only		Malignant Tumor Surgery And Radiation
Arm/Group Description	Non-surgical candidates receive 72 up to 77.l4 Gy of radiation depending on the histology (72 Gy for osteosarcoma and chondrosarcoma and 77.4 Gy for chordoma Radiation: For surgical candidates, the standard treatment includes pre-operative radiation of 50.4 Gy, followed by a recovery period of approximately 4 to 5 weeks. After this surgery will take place. After approximately 6 weeks of recovery, to allow the surgical incision to heal, the patient is treated with another 19.8 Gy up to 27 Gy of radiation postoperatively depending on the final margin status (higher for gross residual disease) Non-surgical candidates receive 72 up to 77.14 Gy of radiation depending on the histology (72 Gy for osteosarcoma and chondrosarcoma and 77.4 Gy for chordoma)		The standard treatment includes pre-operative radiation of 50.4 Gy, followed by a recovery period of approximately 4 to 5 weeks. Surgery involves removing the malignant tumor in the sacrum in one piece, preferably with a cuff of normal tissue around the tumor. After approximately 6 weeks of recovery, the patient is treated with another 19.8 Gy up to 27 Gy of radiation postoperatively depending on the final margin status (higher for gross residual disease). If the wound is not healed or there is another medical reason to delay adjuvant radiation, then radiation may begin later. Radiation: For surgical candidates, the standard treatment includes pre-operative radiation of 50.4 Gy, followed by a recovery period of approximately 4 to 5 weeks. After this surgery will take place. After approximately 6 weeks of recovery, to allow the surgical incision to heal, the patient is treated with another 19.8 Gy up to 27 Gy of radiation postoperatively depending on the final margin status (higher for gross residual disease) Non-surgical candidates receive 72 up to 77.14 Gy of radiation depending on the histology (72 Gy for osteosarcoma and chondrosarcoma and 77.4 Gy for chordoma) Malignant Tumor Surgery: Surgery involves removing the malignant tumor in the sacrum in one piece, preferably with a cuff of normal tissue around the tumor
All Cause Mortality
	Non Surgical-Radiation Only		Malignant Tumor Surgery And Radiation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/2 (0%)		0/10 (0%)
Serious Adverse Events
	Non Surgical-Radiation Only		Malignant Tumor Surgery And Radiation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/2 (0%)		1/10 (10%)
General disorders
Allergic reaction	0/2 (0%)	0	1/10 (10%)	1
Other (Not Including Serious) Adverse Events
	Non Surgical-Radiation Only		Malignant Tumor Surgery And Radiation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/2 (0%)		0/10 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.