NORMAL-R: Non-Operative Radiation Management of Adenocarcinoma of the Lower Rectum

• Sponsor: Washington University School of Medicine (Other)
• Overall Status: Completed
• CT.gov ID: NCT02641691
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arm: 1
• Actual Duration (Months): 46.1
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

The purpose of this research study is to look at how tumors responds to a short course of radiation (5 days) followed by 8 cycles of chemotherapy.

Condition or Disease	Intervention/Treatment	Phase
Cancer of Rectum; Cancer of the Rectum; Neoplasm, Rectum; Rectal Cancer; Rectum Cancer; Rectum Neoplasms; Adenocarcinoma of the Rectum	Radiation: Radiation; Drug: Oxaliplatin; Drug: Leucovorin; Drug: Fluorouracil	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Non-Operative Radiation Management of Adenocarcinoma of the Lower Rectum (NORMAL-R)
• Actual Study Start Date: May 27, 2016
• Actual Primary Completion Date: Feb 4, 2020
• Actual Study Completion Date: Mar 29, 2020

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU Radiotherapy will consist of five fractions, delivered once daily, to a total dose of 25Gy at 5 Gy per fraction. An optional concomitant boost may be delivered to the primary tumor of 1-2 Gy per day (30-35 Gy to tumor total). If a boost is given then the maximum allowed dose to small bowel is 25 Gy. Chemotherapy should begin two weeks (9-12 working days) after completion of radiotherapy. Oxaliplatin will be given intravenous (IV) over 2 hours on Day 1 every 14 days for a maximum of 8 cycles. Leucovorin will be given IV over 2 hours on Day 1 every 14 days for a maximum of 8 cycles. 5-FU bolus will given IV push on Day 1 every 14 days for a maximum of 8 cycles. 5-FU infusion will be given continuous IV on Day 1 over 46 hours every 14 days for a maximum of 8 cycles Alternatively, capecitabine/oxaliplatin (CAPE PO 1000 mg/m2 BID days 1-14 Q21 days, oxaliplatin IV 130 mg/m2 IV Q21 days on day 1) x 5 cycles over 15 weeks may be administered instead of FOLFOX

Radiation: Radiation; Drug: Oxaliplatin; Other Names: Eloxatin® ; Drug: Leucovorin; Other Names: Wellcovorin citrovorum factor folinic acid 5-formyl tetrahydrofolate ; Drug: Fluorouracil; Other Names: 5-Fluorouracil 5-FU

Outcome Measures

Primary Outcome Measures

1. Complete Response Rate [1 year]

   Criteria for complete clinical response: No residual gross tumor at procto/sigmoidoscopy, or only erythematous scar or ulcer No radiographic evidence of tumor on DRE Substantial downsizing on MRI No suspicious mesorectal lymph nodes on MRI Negative biopsy from scar, ulcer, or former tumor site (if necessary according to surgeon's judgment) Criteria for no significant clinical response: Residual disease by DRE, endoscopy or MR. Increase in primary tumor size upon clinical exam or imaging Any new lesions

Secondary Outcome Measures

1. Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire [Baseline]

   -The FACT-C questionnaire is broken down into physical well-being, social/family well-being, emotional well-being, and functional well-being. The answers range from 0 (not at all) to 4 (very much).

2. Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire [Completion of chemoradiation (approximately 112 days)]

   -The FACT-C questionnaire is broken down into physical well-being, social/family well-being, emotional well-being, and functional well-being. The answers range from 0 (not at all) to 4 (very much).

3. Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire [10-14 months after chemoradiation (approximately 16-20 months)]

   -The FACT-C questionnaire is broken down into physical well-being, social/family well-being, emotional well-being, and functional well-being. The answers range from 0 (not at all) to 4 (very much).

4. Number of Any Grade 3 or Higher Toxicities [From start of radiation treatment through 30 days after completion of treatment (approximately 18 weeks)]

   -The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.

5. Number of Post Chemotherapy Grade 3 or Higher Toxicities [Post-chemotherapy through 1 year follow-up (approximately 1 year and 4 months)]

   -The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.

6. Quality of Anorectal Function as Measured by the FACT-C Questionnaire [Baseline]

   -The FACT-C questionnaire has 2 statements about anorectal function and the participant answers 0 (not at all) to 4 (very much)

7. Quality of Anorectal Function as Measured by the FACT-C Questionnaire [Completion of chemoradiation (approximately 112 days)]

   -The FACT-C questionnaire has 2 statements about anorectal function and the participant answers 0 (not at all) to 4 (very much)

8. Quality of Anorectal Function as Measured by the FACT-C Questionnaire [10-14 months after chemoradiation (approximately 16-20 months)]

   -The FACT-C questionnaire has 2 statements about anorectal function and the participant answers 0 (not at all) to 4 (very much)

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Diagnosis of biopsy proven stage I-IIIB (cT1-3, N0-1, M0) adenocarcinoma of the rectum; staging must also be based on multidisciplinary evaluation including MRI and/or endorectal ultrasound

• Tumor ≤ 12 cm from anal verge as determined by MRI or endoscopy a

• ECOG performance status 0-2

• At least 18 years of age

• Adequate bone marrow function defined as:

• ANC > 1,500 cells/mm3

• Hgb > 8 g/dl

• platelets >100,000 cells/mm3

• Women of childbearing 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 must inform her treating physician immediately.

• Able to understand and willing to sign an IRB-approved written informed consent document.

Exclusion Criteria:

• No clinically detectable (MR, endoscopy or DRE) tumor present

• Prior radiation therapy, chemotherapy or extirpative surgery for rectal cancer.

• Any evidence of disease from another malignancy or history of other malignancy ≤ 3 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only or carcinoma in situ of the cervix). Patients with history of prostate cancer treated without radiotherapy and no evidence of disease are eligible.

• Currently receiving any investigational agents.

• A history of allergic reaction attributed to compounds of similar chemical or biologic composition to 5FU, oxaliplatin, or leucovorin.

• Uncontrolled intercurrent 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.

• Pregnant and/or breastfeeding. Women of childbearing potential must have a negative serum pregnancy test within 14 days of study entry.

• Known HIV-positivity and on combination antiretroviral therapy because of the potential for pharmacokinetic interactions with the study drugs. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Washington University School of Medicine	Saint Louis	Missouri	United States	63110

Sponsors and Collaborators

• Washington University School of Medicine

Investigators

• Principal Investigator: Hyun Kim, M.D., Washington University School of Medicine

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jun 1, 2018

More Information

Additional Information:

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Publications

None provided.

• Responsible Party: Washington University School of Medicine
• ClinicalTrials.gov Identifier: NCT02641691
• Other Study ID Numbers: 201512140
• First Posted: Dec 29, 2015
• Last Update Posted: Feb 18, 2021
• Last Verified: Feb 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Neoplasms; Adenocarcinoma; Rectal Neoplasms; Leucovorin; Formyltetrahydrofolates; Tetrahydrofolates; Fluorouracil; Oxaliplatin; Levoleucovorin

Study Results

Participant Flow

Arm/Group Title	Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU
Arm/Group Description	Radiotherapy will consist of five fractions, delivered once daily, to a total dose of 25Gy at 5 Gy per fraction. An optional concomitant boost may be delivered to the primary tumor of 1-2 Gy per day (30-35 Gy to tumor total). If a boost is given then the maximum allowed dose to small bowel is 25 Gy. Chemotherapy should begin two weeks (9-12 working days) after completion of radiotherapy. Oxaliplatin will be given intravenous (IV) over 2 hours on Day 1 every 14 days for a maximum of 8 cycles. Leucovorin will be given IV over 2 hours on Day 1 every 14 days for a maximum of 8 cycles. 5-FU bolus will given IV push on Day 1 every 14 days for a maximum of 8 cycles. 5-FU infusion will be given continuous IV on Day 1 over 46 hours every 14 days for a maximum of 8 cycles Alternatively, capecitabine/oxaliplatin (CAPE PO 1000 mg/m2 BID days 1-14 Q21 days, oxaliplatin IV 130 mg/m2 IV Q21 days on day 1) x 5 cycles over 15 weeks may be administered instead of FOLFOX
Period Title: Overall Study
STARTED	20
COMPLETED	20
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU
Arm/Group Description	Radiotherapy will consist of five fractions, delivered once daily, to a total dose of 25Gy at 5 Gy per fraction. An optional concomitant boost may be delivered to the primary tumor of 1-2 Gy per day (30-35 Gy to tumor total). If a boost is given then the maximum allowed dose to small bowel is 25 Gy. Chemotherapy should begin two weeks (9-12 working days) after completion of radiotherapy. Oxaliplatin will be given intravenous (IV) over 2 hours on Day 1 every 14 days for a maximum of 8 cycles. Leucovorin will be given IV over 2 hours on Day 1 every 14 days for a maximum of 8 cycles. 5-FU bolus will given IV push on Day 1 every 14 days for a maximum of 8 cycles. 5-FU infusion will be given continuous IV on Day 1 over 46 hours every 14 days for a maximum of 8 cycles Alternatively, capecitabine/oxaliplatin (CAPE PO 1000 mg/m2 BID days 1-14 Q21 days, oxaliplatin IV 130 mg/m2 IV Q21 days on day 1) x 5 cycles over 15 weeks may be administered instead of FOLFOX
Overall Participants	20
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	56.5
Sex: Female, Male (Count of Participants)
Female	8 40%
Male	12 60%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 5%
Not Hispanic or Latino	19 95%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	20 100%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	20 100%

Outcome Measures

1. Primary Outcome

Title	Complete Response Rate
Description	Criteria for complete clinical response: No residual gross tumor at procto/sigmoidoscopy, or only erythematous scar or ulcer No radiographic evidence of tumor on DRE Substantial downsizing on MRI No suspicious mesorectal lymph nodes on MRI Negative biopsy from scar, ulcer, or former tumor site (if necessary according to surgeon's judgment) Criteria for no significant clinical response: Residual disease by DRE, endoscopy or MR. Increase in primary tumor size upon clinical exam or imaging Any new lesions
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

1 participant was not evaluable for this outcome measure as they were removed for an adverse event

Arm/Group Title	Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU
Arm/Group Description	Radiotherapy will consist of five fractions, delivered once daily, to a total dose of 25Gy at 5 Gy per fraction. An optional concomitant boost may be delivered to the primary tumor of 1-2 Gy per day (30-35 Gy to tumor total). If a boost is given then the maximum allowed dose to small bowel is 25 Gy. Chemotherapy should begin two weeks (9-12 working days) after completion of radiotherapy. Oxaliplatin will be given intravenous (IV) over 2 hours on Day 1 every 14 days for a maximum of 8 cycles. Leucovorin will be given IV over 2 hours on Day 1 every 14 days for a maximum of 8 cycles. 5-FU bolus will given IV push on Day 1 every 14 days for a maximum of 8 cycles. 5-FU infusion will be given continuous IV on Day 1 over 46 hours every 14 days for a maximum of 8 cycles Alternatively, capecitabine/oxaliplatin (CAPE PO 1000 mg/m2 BID days 1-14 Q21 days, oxaliplatin IV 130 mg/m2 IV Q21 days on day 1) x 5 cycles over 15 weeks may be administered instead of FOLFOX
Measure Participants	19
Count of Participants [Participants]	12 60%

2. Secondary Outcome

Title	Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
Description	-The FACT-C questionnaire is broken down into physical well-being, social/family well-being, emotional well-being, and functional well-being. The answers range from 0 (not at all) to 4 (very much).
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	0=Not at All	1=A Little Bit	2=Somewhat	3=Quite a Bit	4=Very Much	Prefer Not to Answer/No Answer/No
Arm/Group Description	-Participant is asked about specific well-being in the past 7 days	-Participant is asked about specific well-being in the past 7 days	-Participant is asked about specific well-being in the past 7 days	-Participant is asked about specific well-being in the past 7 days	-Participant is asked about specific well-being in the past 7 days	-Participant did not answer question about well-being
Measure Participants	20	20	20	20	20	20
I have a lack of energy	9 45%	3 NaN	6 NaN	2 NaN	0 NaN	0 NaN
I have nausea	19 95%	0 NaN	1 NaN	0 NaN	0 NaN	0 NaN
Because of my physical condition, I have trouble meeting the needs of my family	17 85%	2 NaN	1 NaN	0 NaN	0 NaN	0 NaN
I have pain	11 55%	6 NaN	2 NaN	1 NaN	0 NaN	0 NaN
I am bothered by side effects of treatment	19 95%	0 NaN	0 NaN	0 NaN	0 NaN	1 NaN
I feel ill	19 95%	0 NaN	1 NaN	0 NaN	0 NaN	0 NaN
I am forced to spend time in bed	17 85%	1 NaN	1 NaN	0 NaN	0 NaN	1 NaN
I feel close to my friends	0 0%	0 NaN	1 NaN	1 NaN	18 NaN	0 NaN
I get emotional support from my family	0 0%	0 NaN	0 NaN	0 NaN	20 NaN	0 NaN
I get support from my friends	0 0%	0 NaN	0 NaN	1 NaN	19 NaN	0 NaN
My family has accepted my illness	0 0%	0 NaN	0 NaN	2 NaN	18 NaN	0 NaN
I am satisfied with family communication about my illness	0 0%	0 NaN	0 NaN	1 NaN	19 NaN	0 NaN
I feel close to my partner (or the person who is my main support)	0 0%	0 NaN	1 NaN	0 NaN	19 NaN	0 NaN
I am satisfied with my sex life	0 0%	1 NaN	6 NaN	1 NaN	8 NaN	4 NaN
I feel sad	8 40%	8 NaN	4 NaN	0 NaN	0 NaN	0 NaN
I am satisfied with how I am coping with my illness	2 10%	2 NaN	4 NaN	5 NaN	7 NaN	0 NaN
I am losing hope in the fight against my illness	19 95%	1 NaN	0 NaN	0 NaN	0 NaN	0 NaN
I feel nervous	6 30%	4 NaN	4 NaN	4 NaN	2 NaN	0 NaN
I worry about dying	12 60%	4 NaN	2 NaN	2 NaN	0 NaN	0 NaN
I worry that my condition will get worse	2 10%	9 NaN	5 NaN	4 NaN	0 NaN	0 NaN
I am able to work (include work at home)	0 0%	1 NaN	3 NaN	4 NaN	12 NaN	0 NaN
My work (include work at home) is fulfilling	0 0%	0 NaN	5 NaN	3 NaN	11 NaN	1 NaN
I am able to enjoy life	0 0%	0 NaN	2 NaN	3 NaN	15 NaN	0 NaN
I have accepted my illness	0 0%	0 NaN	2 NaN	6 NaN	12 NaN	0 NaN
I am sleeping well	2 10%	0 NaN	6 NaN	6 NaN	6 NaN	0 NaN
I am enjoying the things I usually do for fun	0 0%	0 NaN	4 NaN	7 NaN	9 NaN	0 NaN
I am content with the quality of my life right now	0 0%	1 NaN	6 NaN	6 NaN	7 NaN	0 NaN
I have swelling or cramps in my stomach area	14 70%	5 NaN	0 NaN	0 NaN	1 NaN	0 NaN
I am losing weight	10 50%	5 NaN	2 NaN	3 NaN	0 NaN	0 NaN
I have control of my bowels	1 5%	0 NaN	5 NaN	3 NaN	11 NaN	0 NaN
I can digest my food well	0 0%	0 NaN	2 NaN	4 NaN	13 NaN	1 NaN
I have diarrhea (diarrhoea)	9 45%	5 NaN	4 NaN	0 NaN	2 NaN	0 NaN
I have a good appetite	1 5%	0 NaN	0 NaN	6 NaN	13 NaN	0 NaN
I like the appearance of my body	0 0%	2 NaN	4 NaN	8 NaN	6 NaN	0 NaN
I am embarrassed by my ostomy appliance	0 0%	0 NaN	0 NaN	0 NaN	0 NaN	20 NaN
Caring for my ostomy appliance is difficult	0 0%	0 NaN	0 NaN	0 NaN	0 NaN	20 NaN

3. Secondary Outcome

Title	Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
Description	-The FACT-C questionnaire is broken down into physical well-being, social/family well-being, emotional well-being, and functional well-being. The answers range from 0 (not at all) to 4 (very much).
Time Frame	Completion of chemoradiation (approximately 112 days)

Outcome Measure Data

Analysis Population Description

One participant was not evaluable for this outcome measure because they did not complete chemoradiation.

Arm/Group Title	0=Not at All	1=A Little Bit	2=Somewhat	3=Quite a Bit	4=Very Much	Prefer Not to Answer/No Answer/No
Arm/Group Description	-Participant is asked about specific well-being in the past 7 days	-Participant is asked about specific well-being in the past 7 days	-Participant is asked about specific well-being in the past 7 days	-Participant is asked about specific well-being in the past 7 days	-Participant is asked about specific well-being in the past 7 days	-Participant did not answer question about well-being
Measure Participants	19	19	19	19	19	19
I have a lack of energy	3 15%	3 NaN	11 NaN	2 NaN	0 NaN	0 NaN
I have nausea	16 80%	3 NaN	0 NaN	0 NaN	0 NaN	0 NaN
Because of my physical condition, I have trouble meeting the needs of my family	8 40%	8 NaN	2 NaN	0 NaN	1 NaN	0 NaN
I have pain	11 55%	3 NaN	4 NaN	0 NaN	0 NaN	1 NaN
I am bothered by side effects of treatment	6 30%	7 NaN	3 NaN	2 NaN	1 NaN	0 NaN
I feel ill	16 80%	2 NaN	0 NaN	0 NaN	0 NaN	1 NaN
I am forced to spend time in bed	13 65%	6 NaN	0 NaN	0 NaN	0 NaN	0 NaN
I feel close to my friends	0 0%	1 NaN	1 NaN	3 NaN	14 NaN	0 NaN
I get emotional support from my family	0 0%	1 NaN	1 NaN	2 NaN	15 NaN	0 NaN
I get support from my friends	1 5%	0 NaN	1 NaN	1 NaN	16 NaN	0 NaN
My family has accepted my illness	1 5%	0 NaN	1 NaN	3 NaN	14 NaN	0 NaN
I am satisfied with family communication about my illness	1 5%	0 NaN	2 NaN	2 NaN	14 NaN	0 NaN
I feel close to my partner (or the person who is my main support)	0 0%	0 NaN	2 NaN	0 NaN	17 NaN	0 NaN
I am satisfied with my sex life	1 5%	1 NaN	8 NaN	1 NaN	5 NaN	3 NaN
I feel sad	10 50%	5 NaN	3 NaN	1 NaN	0 NaN	0 NaN
I am satisfied with how I am coping with my illness	3 15%	0 NaN	4 NaN	8 NaN	4 NaN	0 NaN
I am losing hope in the fight against my illness	16 80%	1 NaN	2 NaN	0 NaN	0 NaN	0 NaN
I feel nervous	5 25%	11 NaN	3 NaN	0 NaN	0 NaN	0 NaN
I worry about dying	12 60%	6 NaN	0 NaN	1 NaN	0 NaN	0 NaN
I worry that my condition will get worse	4 20%	11 NaN	3 NaN	1 NaN	0 NaN	0 NaN
I am able to work (include work at home)	1 5%	4 NaN	3 NaN	3 NaN	8 NaN	0 NaN
My work (include work at home) is fulfilling	0 0%	4 NaN	5 NaN	2 NaN	8 NaN	0 NaN
I am able to enjoy life	0 0%	2 NaN	3 NaN	7 NaN	7 NaN	0 NaN
I have accepted my illness	1 5%	2 NaN	1 NaN	6 NaN	9 NaN	0 NaN
I am sleeping well	0 0%	2 NaN	3 NaN	6 NaN	7 NaN	1 NaN
I am enjoying the things I usually do for fun	0 0%	3 NaN	4 NaN	6 NaN	6 NaN	0 NaN
I am content with the quality of my life right now	0 0%	2 NaN	6 NaN	5 NaN	6 NaN	0 NaN
I have swelling or cramps in my stomach area	13 65%	4 NaN	1 NaN	1 NaN	0 NaN	0 NaN
I am losing weight	11 55%	6 NaN	1 NaN	0 NaN	0 NaN	1 NaN
I have control of my bowels	1 5%	4 NaN	6 NaN	4 NaN	4 NaN	0 NaN
I can digest my food well	0 0%	2 NaN	3 NaN	3 NaN	10 NaN	1 NaN
I have diarrhea (diarrhoea)	4 20%	10 NaN	2 NaN	2 NaN	1 NaN	0 NaN
I have a good appetite	1 5%	1 NaN	5 NaN	7 NaN	4 NaN	1 NaN
I like the appearance of my body	2 10%	3 NaN	8 NaN	3 NaN	3 NaN	0 NaN
I am embarrassed by my ostomy appliance	1 5%	0 NaN	0 NaN	0 NaN	0 NaN	18 NaN
Caring for my ostomy appliance is difficult	1 5%	0 NaN	0 NaN	0 NaN	0 NaN	18 NaN

4. Secondary Outcome

Title	Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
Description	-The FACT-C questionnaire is broken down into physical well-being, social/family well-being, emotional well-being, and functional well-being. The answers range from 0 (not at all) to 4 (very much).
Time Frame	10-14 months after chemoradiation (approximately 16-20 months)

Outcome Measure Data

Analysis Population Description

One participant was not evaluable for this outcome measure because they did not complete chemoradiation. One participant was not evaluable for this outcome measure because they expired prior to this timepoint.

Arm/Group Title	0=Not at All	1=A Little Bit	2=Somewhat	3=Quite a Bit	4=Very Much	Prefer Not to Answer/No Answer/No
Arm/Group Description	-Participant is asked about specific well-being in the past 7 days	-Participant is asked about specific well-being in the past 7 days	-Participant is asked about specific well-being in the past 7 days	-Participant is asked about specific well-being in the past 7 days	-Participant is asked about specific well-being in the past 7 days	-Participant did not answer question about well-being
Measure Participants	18	18	18	18	18	18
I have a lack of energy	4 20%	5 NaN	5 NaN	4 NaN	0 NaN	0 NaN
I have nausea	17 85%	0 NaN	1 NaN	0 NaN	0 NaN	0 NaN
Because of my physical condition, I have trouble meeting the needs of my family	10 50%	4 NaN	4 NaN	0 NaN	0 NaN	0 NaN
I have pain	9 45%	5 NaN	3 NaN	0 NaN	1 NaN	0 NaN
I am bothered by side effects of treatment	5 25%	2 NaN	6 NaN	3 NaN	2 NaN	0 NaN
I feel ill	15 75%	2 NaN	1 NaN	0 NaN	0 NaN	0 NaN
I am forced to spend time in bed	14 70%	2 NaN	1 NaN	1 NaN	0 NaN	0 NaN
I feel close to my friends	0 0%	0 NaN	2 NaN	4 NaN	12 NaN	0 NaN
I get emotional support from my family	0 0%	0 NaN	1 NaN	2 NaN	15 NaN	0 NaN
I get support from my friends	0 0%	0 NaN	2 NaN	2 NaN	13 NaN	1 NaN
My family has accepted my illness	0 0%	0 NaN	2 NaN	2 NaN	14 NaN	0 NaN
I am satisfied with family communication about my illness	0 0%	0 NaN	1 NaN	1 NaN	15 NaN	1 NaN
I feel close to my partner (or the person who is my main support)	0 0%	0 NaN	2 NaN	1 NaN	15 NaN	0 NaN
I am satisfied with my sex life	5 25%	0 NaN	2 NaN	2 NaN	4 NaN	5 NaN
I feel sad	9 45%	6 NaN	3 NaN	0 NaN	0 NaN	0 NaN
I am satisfied with how I am coping with my illness	3 15%	0 NaN	4 NaN	4 NaN	7 NaN	0 NaN
I am losing hope in the fight against my illness	15 75%	1 NaN	1 NaN	0 NaN	1 NaN	0 NaN
I feel nervous	6 30%	6 NaN	4 NaN	1 NaN	1 NaN	0 NaN
I worry about dying	10 50%	5 NaN	2 NaN	1 NaN	0 NaN	0 NaN
I worry that my condition will get worse	5 25%	7 NaN	5 NaN	1 NaN	0 NaN	0 NaN
I am able to work (include work at home)	1 5%	2 NaN	3 NaN	3 NaN	9 NaN	0 NaN
My work (include work at home) is fulfilling	1 5%	0 NaN	6 NaN	2 NaN	9 NaN	0 NaN
I am able to enjoy life	0 0%	1 NaN	5 NaN	5 NaN	7 NaN	0 NaN
I have accepted my illness	0 0%	0 NaN	5 NaN	5 NaN	7 NaN	1 NaN
I am sleeping well	1 5%	1 NaN	4 NaN	5 NaN	6 NaN	1 NaN
I am enjoying the things I usually do for fun	0 0%	4 NaN	4 NaN	6 NaN	3 NaN	1 NaN
I am content with the quality of my life right now	0 0%	5 NaN	5 NaN	3 NaN	4 NaN	1 NaN
I have swelling or cramps in my stomach area	12 60%	1 NaN	2 NaN	2 NaN	1 NaN	0 NaN
I am losing weight	15 75%	2 NaN	0 NaN	0 NaN	1 NaN	0 NaN
I have control of my bowels	2 10%	2 NaN	7 NaN	5 NaN	2 NaN	0 NaN
I can digest my food well	0 0%	1 NaN	5 NaN	2 NaN	10 NaN	0 NaN
I have diarrhea (diarrhoea)	6 30%	6 NaN	2 NaN	2 NaN	2 NaN	0 NaN
I have a good appetite	1 5%	0 NaN	3 NaN	4 NaN	10 NaN	0 NaN
I like the appearance of my body	3 15%	2 NaN	8 NaN	2 NaN	3 NaN	0 NaN
I am embarrassed by my ostomy appliance	1 5%	0 NaN	1 NaN	0 NaN	1 NaN	15 NaN
Caring for my ostomy appliance is difficult	1 5%	2 NaN	0 NaN	0 NaN	0 NaN	15 NaN

5. Secondary Outcome

Title	Number of Any Grade 3 or Higher Toxicities
Description	-The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.
Time Frame	From start of radiation treatment through 30 days after completion of treatment (approximately 18 weeks)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU
Arm/Group Description	Radiotherapy will consist of five fractions, delivered once daily, to a total dose of 25Gy at 5 Gy per fraction. An optional concomitant boost may be delivered to the primary tumor of 1-2 Gy per day (30-35 Gy to tumor total). If a boost is given then the maximum allowed dose to small bowel is 25 Gy. Chemotherapy should begin two weeks (9-12 working days) after completion of radiotherapy. Oxaliplatin will be given intravenous (IV) over 2 hours on Day 1 every 14 days for a maximum of 8 cycles. Leucovorin will be given IV over 2 hours on Day 1 every 14 days for a maximum of 8 cycles. 5-FU bolus will given IV push on Day 1 every 14 days for a maximum of 8 cycles. 5-FU infusion will be given continuous IV on Day 1 over 46 hours every 14 days for a maximum of 8 cycles Alternatively, capecitabine/oxaliplatin (CAPE PO 1000 mg/m2 BID days 1-14 Q21 days, oxaliplatin IV 130 mg/m2 IV Q21 days on day 1) x 5 cycles over 15 weeks may be administered instead of FOLFOX
Measure Participants	20
Anemia	2 10%
Febrile neutropenia	2 10%
Cardiac arrest	1 5%
Myocardial infarction	1 5%
Ventricular fibrillation	1 5%
Abdominal pain	1 5%
Diarrhea	3 15%
Pancreatitis	1 5%
Fever	1 5%
Cholectystitis	1 5%
Lung infection	1 5%
Fall	1 5%
Activated partial thromboplastin time prolonged	1 5%
Aspartate aminotransferase increased	1 5%
Cardiac troponin I increased	1 5%
Cardiac troponin T increased	1 5%
Lymphocyte count decreased	3 15%
Neutrophil count decreased	5 25%
White blood cell decreased	2 10%
Dehydration	2 10%
Hyperglycemia	1 5%
Hypokalemia	2 10%
Hyponatremia	2 10%
Generalized muscle weakness	1 5%
Peripheral sensory neuropathy	2 10%
Syncope	1 5%
Respiratory failure	1 5%
Aspiration	1 5%
Dyspnea	2 10%
Hypoxia	1 5%
Palmar-plantar erythrodysesthesia syndrome	1 5%
Cellulitis	1 5%
Hypertension	1 5%
Hypotension	2 10%
Thromboembolic event	1 5%

6. Secondary Outcome

Title	Number of Post Chemotherapy Grade 3 or Higher Toxicities
Description	-The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.
Time Frame	Post-chemotherapy through 1 year follow-up (approximately 1 year and 4 months)

Outcome Measure Data

Analysis Population Description

One participant was not evaluable for this outcome measure because they did not complete chemoradiation.

Arm/Group Title	Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU
Arm/Group Description	Radiotherapy will consist of five fractions, delivered once daily, to a total dose of 25Gy at 5 Gy per fraction. An optional concomitant boost may be delivered to the primary tumor of 1-2 Gy per day (30-35 Gy to tumor total). If a boost is given then the maximum allowed dose to small bowel is 25 Gy. Chemotherapy should begin two weeks (9-12 working days) after completion of radiotherapy. Oxaliplatin will be given intravenous (IV) over 2 hours on Day 1 every 14 days for a maximum of 8 cycles. Leucovorin will be given IV over 2 hours on Day 1 every 14 days for a maximum of 8 cycles. 5-FU bolus will given IV push on Day 1 every 14 days for a maximum of 8 cycles. 5-FU infusion will be given continuous IV on Day 1 over 46 hours every 14 days for a maximum of 8 cycles Alternatively, capecitabine/oxaliplatin (CAPE PO 1000 mg/m2 BID days 1-14 Q21 days, oxaliplatin IV 130 mg/m2 IV Q21 days on day 1) x 5 cycles over 15 weeks may be administered instead of FOLFOX
Measure Participants	19
Anemia	2 10%
Febrile neutropenia	2 10%
Cardiac arrest	1 5%
Myocardial infarction	1 5%
Ventricular fibrillation	1 5%
Abdominal pain	1 5%
Diarrhea	3 15%
Fever	2 10%
Cholecystitis	1 5%
Lung infection	1 5%
Activated partial thromboplastin time prolonged	1 5%
Aspartate aminotransferase increased	1 5%
Cardiac troponin I increased	1 5%
Cardiac troponin T increased	1 5%
Lymphocyte count decreased	3 15%
Neutrophil count decreased	5 25%
White blood cell count decreased	2 10%
Dehydration	1 5%
Hyperglycemia	1 5%
Hypokalemia	2 10%
Hyponatremia	2 10%
Generalized muscle weakness	1 5%
Peripheral sensory neuropathy	2 10%
Syncope	1 5%
Respiratory failure	1 5%
Aspiration	1 5%
Dyspnea	1 5%
Hypoxia	1 5%
Cellulitis	1 5%
Hypotension	1 5%
Thromboembolic event	1 5%

7. Secondary Outcome

Title	Quality of Anorectal Function as Measured by the FACT-C Questionnaire
Description	-The FACT-C questionnaire has 2 statements about anorectal function and the participant answers 0 (not at all) to 4 (very much)
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	0=Not at All	1=A Little Bit	2=Somewhat	3=Quite a Bit	4=Very Much
Arm/Group Description	-Participant is asked about specific well-being in the past 7 days	-Participant is asked about specific well-being in the past 7 days	-Participant is asked about specific well-being in the past 7 days	-Participant is asked about specific well-being in the past 7 days	-Participant is asked about specific well-being in the past 7 days
Measure Participants	20	20	20	20	20
I have control of my bowels	1 5%	0 NaN	5 NaN	3 NaN	11 NaN
I have diarrhea (diarrhoea)	9 45%	5 NaN	4 NaN	0 NaN	2 NaN

8. Secondary Outcome

Title	Quality of Anorectal Function as Measured by the FACT-C Questionnaire
Description	-The FACT-C questionnaire has 2 statements about anorectal function and the participant answers 0 (not at all) to 4 (very much)
Time Frame	Completion of chemoradiation (approximately 112 days)

Outcome Measure Data

Analysis Population Description

One participant was not evaluable for this outcome measure because they did not complete chemoradiation.

Arm/Group Title	0=Not at All	1=A Little Bit	2=Somewhat	3=Quite a Bit	4=Very Much
Arm/Group Description	-Participant is asked about specific well-being in the past 7 days	-Participant is asked about specific well-being in the past 7 days	-Participant is asked about specific well-being in the past 7 days	-Participant is asked about specific well-being in the past 7 days	-Participant is asked about specific well-being in the past 7 days
Measure Participants	19	19	19	19	19
I have control of my bowels	1 5%	4 NaN	6 NaN	4 NaN	4 NaN
I have diarrhea (diarrhoea)	4 20%	10 NaN	2 NaN	2 NaN	1 NaN

9. Secondary Outcome

Title	Quality of Anorectal Function as Measured by the FACT-C Questionnaire
Description	-The FACT-C questionnaire has 2 statements about anorectal function and the participant answers 0 (not at all) to 4 (very much)
Time Frame	10-14 months after chemoradiation (approximately 16-20 months)

Outcome Measure Data

Analysis Population Description

One participant was not evaluable for this outcome measure because they did not complete chemoradiation. One participant was not evaluable for this outcome measure because they expired prior to this timepoint.

Arm/Group Title	0=Not at All	1=A Little Bit	2=Somewhat	3=Quite a Bit	4=Very Much
Arm/Group Description	-Participant is asked about specific well-being in the past 7 days	-Participant is asked about specific well-being in the past 7 days	-Participant is asked about specific well-being in the past 7 days	-Participant is asked about specific well-being in the past 7 days	-Participant is asked about specific well-being in the past 7 days
Measure Participants	18	18	18	18	18
I have control of my bowels	2 10%	2 NaN	7 NaN	5 NaN	2 NaN
I have diarrhea (diarrhoea)	6 30%	6 NaN	2 NaN	2 NaN	2 NaN

Adverse Events

Time Frame	Adverse events were collected from start of treatment until 1 year post start of radiation therapy (approximately 1 year and 4 months).
Arm/Group Title	Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU
Arm/Group Description	Radiotherapy will consist of five fractions, delivered once daily, to a total dose of 25Gy at 5 Gy per fraction. An optional concomitant boost may be delivered to the primary tumor of 1-2 Gy per day (30-35 Gy to tumor total). If a boost is given then the maximum allowed dose to small bowel is 25 Gy. Chemotherapy should begin two weeks (9-12 working days) after completion of radiotherapy. Oxaliplatin will be given intravenous (IV) over 2 hours on Day 1 every 14 days for a maximum of 8 cycles. Leucovorin will be given IV over 2 hours on Day 1 every 14 days for a maximum of 8 cycles. 5-FU bolus will given IV push on Day 1 every 14 days for a maximum of 8 cycles. 5-FU infusion will be given continuous IV on Day 1 over 46 hours every 14 days for a maximum of 8 cycles Alternatively, capecitabine/oxaliplatin (CAPE PO 1000 mg/m2 BID days 1-14 Q21 days, oxaliplatin IV 130 mg/m2 IV Q21 days on day 1) x 5 cycles over 15 weeks may be administered instead of FOLFOX
All Cause Mortality
	Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU
	Affected / at Risk (%)	# Events
Total	1/20 (5%)
Serious Adverse Events
	Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU
	Affected / at Risk (%)	# Events
Total	8/20 (40%)
Blood and lymphatic system disorders
Febrile neutropenia	1/20 (5%)
Cardiac disorders
Myocardial infarction	1/20 (5%)
Cardiac arrest	1/20 (5%)
Gastrointestinal disorders
Pancreatitis	1/20 (5%)
Infections and infestations
Lung infection	1/20 (5%)
Injury, poisoning and procedural complications
Fall	1/20 (5%)
Metabolism and nutrition disorders
Dehydration	1/20 (5%)
Nervous system disorders
Syncope	1/20 (5%)
Respiratory, thoracic and mediastinal disorders
Dyspnea	2/20 (10%)
Vascular disorders
Hypotension	2/20 (10%)
Thromboembolic event	1/20 (5%)
Other (Not Including Serious) Adverse Events
	Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU
	Affected / at Risk (%)	# Events
Total	20/20 (100%)
Blood and lymphatic system disorders
Anemia	3/20 (15%)
Febrile neutropenia	1/20 (5%)
Cardiac disorders
Ventricular fibrillation	1/20 (5%)
Gastrointestinal disorders
Abdominal pain	2/20 (10%)
Constipation	1/20 (5%)
Diarrhea	5/20 (25%)
Mucositis oral	1/20 (5%)
Nausea	1/20 (5%)
Rectal pain	1/20 (5%)
General disorders
Fatigue	4/20 (20%)
Fever	1/20 (5%)
Generalized muscle weakness	1/20 (5%)
Hepatobiliary disorders
Cholecystitis	1/20 (5%)
Investigations
Activated partial thromboplastin time prolonged	1/20 (5%)
Aspartate aminotransferase	1/20 (5%)
Cardiac troponin I increased	1/20 (5%)
Cardiac troponin T increased	1/20 (5%)
Lymphocyte count decreased	3/20 (15%)
Neutrophil count decreased	5/20 (25%)
Platelet count decreased	1/20 (5%)
White blood cell decreased	3/20 (15%)
Metabolism and nutrition disorders
Anorexia	1/20 (5%)
Dehydration	1/20 (5%)
Hyperglycemia	1/20 (5%)
Hypoalbuminemia	1/20 (5%)
Hypokalemia	2/20 (10%)
Hyponatremia	3/20 (15%)
Musculoskeletal and connective tissue disorders
Leg pain	1/20 (5%)
Back pain	1/20 (5%)
Myalgia	1/20 (5%)
Nervous system disorders
Peripheral sensory neuropathy	1/20 (5%)
Cold sensitivity	1/20 (5%)
Dizziness	1/20 (5%)
Headache	1/20 (5%)
Peripheral sensory neuropathy	6/20 (30%)
Psychiatric disorders
Anxiety	2/20 (10%)
Insomnia	2/20 (10%)
Renal and urinary disorders
Hematuria	1/20 (5%)
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure	1/20 (5%)
Aspiration	1/20 (5%)
Hoarseness	1/20 (5%)
Hypoxia	1/20 (5%)
Skin and subcutaneous tissue disorders
Bottom of feet felt sun burnt	1/20 (5%)
Hand-foot skin reaction	1/20 (5%)
Cellulitis	1/20 (5%)
Rash maculo-papular	1/20 (5%)
Vascular disorders
Hypertension	1/20 (5%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE 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.