CH01: Proton Therapy for Chordomas and/or Chondrosarcomas
Sponsor
University of Florida (Other)
Overall Status
Completed
CT.gov ID
NCT00797602
Collaborator
(none)
189
1
107
1.8
Study Details
Study Description
Brief Summary
The purpose of this study is to collect information from medical records to see what effects proton beam radiation has on cancer and analyze possible side effects.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Detailed Description
Data collection will be obtained from the patient's medical records including initial evaluation, pathology report, dosimetry information, radiotherapy completion records and follow-up.
Study Design
Study Type:
Observational
Actual Enrollment
:
189 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
A Clinical Outcomes Protocol of Proton Beam Radiation Therapy for Chordomas and/or Chondrosarcomas of the Base of Skull and/or Spine
Study Start Date
:
Jan 1, 2007
Actual Primary Completion Date
:
Dec 1, 2015
Actual Study Completion Date
:
Dec 1, 2015
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Proton Radiation
|
Outcome Measures
Primary Outcome Measures
- Collect and analyze outcome data on tumor control. [When each patient has been followed for a minimum of 12 month and then again after 24 months to a maximum of 10 years.]
Secondary Outcome Measures
- Collect and analyze data on normal tissue morbidity. [When each patient has been followed for a minimum of 12 months and then again after 24 months to a maximum of 10 years.]
Specifically analyzing pituitary, visual and hearing function.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Histologically proven chordoma or chondrosarcoma.
-
Sites: base of skull and/or spine.
-
Age 18 years or older.
Exclusion Criteria:
-
Previous radiation to the head and neck or brain.
-
Evidence of metastatic disease.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Florida Proton Therapy Institute | Jacksonville | Florida | United States | 32206 |
Sponsors and Collaborators
- University of Florida
Investigators
- Principal Investigator: Ronny L Rotondo, MD, University of Florida Proton Therapy Institute
Study Documents (Full-Text)
None provided.More Information
Publications
- al-Mefty O, Borba LA. Skull base chordomas: a management challenge. J Neurosurg. 1997 Feb;86(2):182-9.
- Austin JP, Urie MM, Cardenosa G, Munzenrider JE. Probable causes of recurrence in patients with chordoma and chondrosarcoma of the base of skull and cervical spine. Int J Radiat Oncol Biol Phys. 1993 Feb 15;25(3):439-44.
- Berson AM, Castro JR, Petti P, Phillips TL, Gauger GE, Gutin P, Collier JM, Henderson SD, Baken K. Charged particle irradiation of chordoma and chondrosarcoma of the base of skull and cervical spine: the Lawrence Berkeley Laboratory experience. Int J Radiat Oncol Biol Phys. 1988 Sep;15(3):559-65.
- Bhandare N, Monroe AT, Morris CG, Bhatti MT, Mendenhall WM. Does altered fractionation influence the risk of radiation-induced optic neuropathy? Int J Radiat Oncol Biol Phys. 2005 Jul 15;62(4):1070-7.
- Campbell WM, McDonald TJ, Unni KK, Laws ER Jr. Nasal and paranasal presentations of chordomas. Laryngoscope. 1980 Apr;90(4):612-8.
- Catton C, O'Sullivan B, Bell R, Laperriere N, Cummings B, Fornasier V, Wunder J. Chordoma: long-term follow-up after radical photon irradiation. Radiother Oncol. 1996 Oct;41(1):67-72.
- Dahlin DC, Unni KK: Bone tumors general aspects and data on 8542 cases, 4th edition. Springfield, IL: Charles C Thomas, 1986, pp 119 - 140.
- Fagundes MA, Hug EB, Liebsch NJ, Daly W, Efird J, Munzenrider JE. Radiation therapy for chordomas of the base of skull and cervical spine: patterns of failure and outcome after relapse. Int J Radiat Oncol Biol Phys. 1995 Oct 15;33(3):579-84.
- Fuller DB, Bloom JG. Radiotherapy for chordoma. Int J Radiat Oncol Biol Phys. 1988 Aug;15(2):331-9.
- Hug EB, Sweeney RA, Nurre PM, Holloway KC, Slater JD, Munzenrider JE. Proton radiotherapy in management of pediatric base of skull tumors. Int J Radiat Oncol Biol Phys. 2002 Mar 15;52(4):1017-24.
- McMaster ML, Goldstein AM, Bromley CM, Ishibe N, Parry DM. Chordoma: incidence and survival patterns in the United States, 1973-1995. Cancer Causes Control. 2001 Jan;12(1):1-11.
- Mendenhall WM, Mendenhall CM, Lewis SB, Villaret DB, Mendenhall NP. Skull base chordoma. Head Neck. 2005 Feb;27(2):159-65. Review.
- Noël G, Habrand JL, Jauffret E, de Crevoisier R, Dederke S, Mammar H, Haie-Méder C, Pontvert D, Hasboun D, Ferrand R, Boisserie G, Beaudré A, Gaboriaud G, Guedea F, Petriz L, Mazeron JJ. Radiation therapy for chordoma and chondrosarcoma of the skull base and the cervical spine. Prognostic factors and patterns of failure. Strahlenther Onkol. 2003 Apr;179(4):241-8.
- O'Connell JX, Renard LG, Liebsch NJ, Efird JT, Munzenrider JE, Rosenberg AE. Base of skull chordoma. A correlative study of histologic and clinical features of 62 cases. Cancer. 1994 Oct 15;74(8):2261-7.
- Parsons JT, Bova FJ, Fitzgerald CR, Mendenhall WM, Million RR. Radiation optic neuropathy after megavoltage external-beam irradiation: analysis of time-dose factors. Int J Radiat Oncol Biol Phys. 1994 Nov 15;30(4):755-63.
- Parsons JT, Bova FJ, Fitzgerald CR, Mendenhall WM, Million RR. Radiation retinopathy after external-beam irradiation: analysis of time-dose factors. Int J Radiat Oncol Biol Phys. 1994 Nov 15;30(4):765-73.
- Pearlman AW, Friedman M. Radical radiation therapy of chordoma. Am J Roentgenol Radium Ther Nucl Med. 1970 Feb;108(2):332-41.
- Terahara A, Niemierko A, Goitein M, Finkelstein D, Hug E, Liebsch N, O'Farrell D, Lyons S, Munzenrider J. Analysis of the relationship between tumor dose inhomogeneity and local control in patients with skull base chordoma. Int J Radiat Oncol Biol Phys. 1999 Sep 1;45(2):351-8.
Responsible Party:
University of Florida
ClinicalTrials.gov Identifier:
NCT00797602
Other Study ID Numbers:
- UFPTI 0607-CH01
First Posted:
Nov 25, 2008
Last Update Posted:
Aug 14, 2017
Last Verified:
Aug 1, 2017
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by University of Florida
Additional relevant MeSH terms: