Back to resultsCharged Particle RT for Chordomas and Chondrosarcomas of the Base of Skull or Cervical Spine
Primary Purpose
Chordoma, Chondrosarcoma
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Charged Particle Radiation Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Chordoma focused on measuring charged particle radiation therapy
Eligibility Criteria
Inclusion Criteria:
- Biopsy proven chordoma. Slides must be reviewed prior to randomization by the central review pathologist
- Sites: Intercranial (sphenoid, clivus, petrous, basio-occiput) or cervical spine
- Boost target volume less than or equal to 150
- 18 years of age or older
- Karnofsky Performance Status > 50
- Neurologic Function of I or II
- No evidence of metastases
Exclusion Criteria:
- Previous radiation to the head or neck that would compromise the ability to deliver the prescribed treatment
- Concurrent or prior malignancy unless disease free for 5 or more years
- Evidence of metastatic disease
- Diabetes mellitus
- Major medical illness or psychiatric impairments that in the opinion of the investigator, will prevent administration or completion of the protocol therapy
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group 1
Group 2
Arm Description
40-44 Treatments
37-40 Treatments
Outcomes
Primary Outcome Measures
Acute Toxicity
Secondary Outcome Measures
Establish local control rates for both dose schedules.
To provide date to be used as the basis for choosing the dose of charged particle radiation for chordomas of the base of skull and the cervical spine.
Late Toxicity
Full Information
NCT ID
NCT00592748
First Posted
December 28, 2007
Last Updated
June 14, 2017
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00592748
Brief Title
Charged Particle RT for Chordomas and Chondrosarcomas of the Base of Skull or Cervical Spine
Official Title
Randomized Study of Charged Particle RT for Chordomas and Chondrosarcomas of the Base of Skull or Cervical Spine
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
June 1999 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The primary purpose of this study is to determine if the administration of a higher dose would decrease the chance of tumor recurrence, compared to the risk of tumor recurrence with a lower dose. Most of the treatment will be given protons, but participants may receive a small portion of treatment with x-rays, because less radiation is given to the skin with x-rays. This study uses two slightly different doses of radiation It is not clear at this time which of the dose levels is better.
Detailed Description
Participants will be assigned to a dose level by random chance, like flipping a coin.
A treatment plan will be determined by a treatment planning CT scan and will either involve 40-44 treatments or 37-40 treatments.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chordoma, Chondrosarcoma
Keywords
charged particle radiation therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
381 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
40-44 Treatments
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
37-40 Treatments
Intervention Type
Radiation
Intervention Name(s)
Charged Particle Radiation Therapy
Intervention Description
Radiation doses will be determined by planning CT
Primary Outcome Measure Information:
Title
Acute Toxicity
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Establish local control rates for both dose schedules.
Time Frame
5 years
Title
To provide date to be used as the basis for choosing the dose of charged particle radiation for chordomas of the base of skull and the cervical spine.
Time Frame
5 years
Title
Late Toxicity
Time Frame
5 Years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Biopsy proven chordoma. Slides must be reviewed prior to randomization by the central review pathologist
Sites: Intercranial (sphenoid, clivus, petrous, basio-occiput) or cervical spine
Boost target volume less than or equal to 150
18 years of age or older
Karnofsky Performance Status > 50
Neurologic Function of I or II
No evidence of metastases
Exclusion Criteria:
Previous radiation to the head or neck that would compromise the ability to deliver the prescribed treatment
Concurrent or prior malignancy unless disease free for 5 or more years
Evidence of metastatic disease
Diabetes mellitus
Major medical illness or psychiatric impairments that in the opinion of the investigator, will prevent administration or completion of the protocol therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Norbert J. Liebsch, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Charged Particle RT for Chordomas and Chondrosarcomas of the Base of Skull or Cervical Spine
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