Randomized Study of Charged Particle RT for Chordomas and Chondrosarcomas of the Base of Skull or Cervical Spine
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 381
- Locations
- 1
- Primary Endpoint
- Acute Toxicity
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Group 2
37-40 Treatments
Intervention: Charged Particle Radiation Therapy (Radiation)
Group 1
40-44 Treatments
Intervention: Charged Particle Radiation Therapy (Radiation)
Outcomes
Primary Outcomes
Acute Toxicity
Time Frame: 90 days
Secondary Outcomes
- Establish local control rates for both dose schedules.(5 years)
- Late Toxicity(5 Years)
- 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.(5 years)
Investigators
Norbert J. Liebsch, M.D.
Director, Skull-Based Service
Massachusetts General Hospital