Charged Particle RT for Chordomas and Chondrosarcomas of the Base of Skull or Cervical Spine

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized Study of Charged Particle RT for Chordomas and Chondrosarcomas of the Base of Skull or Cervical Spine

Conditions
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Chordoma, Chondrosarcoma

Intervention / Treatment
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* Radiation: Charged Particle Radiation Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br>40-44 Treatments | Radiation: Charged Particle Radiation Therapy<br>* Radiation doses will be determined by planning CT<br>|
| Active Comparator: Group 2<br>37-40 Treatments | Radiation: Charged Particle Radiation Therapy<br>* Radiation doses will be determined by planning CT<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute Toxicity |  | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Establish local control rates for both dose schedules. |  | 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 | 
| Late Toxicity |  | 5 Years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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charged particle radiation therapy