Proton Radiation for Chordomas and Chondrosarcomas

Study Overview
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Brief Summary
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The objectives of this study are 1) To evaluate the feasibility and acute side effects of proton therapy for chordomas and chondrosarcomas and 2) To evaluate clinical outcomes and long term side effects of proton beam radiation for treatment of chordomas and chondrosarcomas.

Detailed Description
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This trial will be conducted in two phases: a feasibility then a phase II trial. Once feasibility and safety are established in the first 12 pts. the phase II study will begin. Proton therapy at standard doses is not known to improve clinical outcome but will likely reduce fatigue and toxicity.

Official Title
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Proton Radiation For Chordomas and Chondrosarcomas

Conditions
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Chordomas, Chondrosarcomas

Intervention / Treatment
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* Radiation: Proton Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed diagnosis of chordoma or chondrosarcoma. Patients must have no evidence of metastatic disease based on routine imaging (CT or MRI of the chest/abdomen/pelvis, bone scan, etc.) Patients must have an ECOG score equal to or less than 2. Age ≥ 18 years. Patients must be able to provide informed consent. Adequate bone marrow function: WBC ≥ 4000/mm3, platelets ≥ 100, 000mm3 Women of child-bearing potential as long as she agrees to use a recognized method of birth control (e.g. oral contraceptive , IUD, condoms or other barrier methods etc.) Hysterectomy or menopause must be clinically documented. Tumors arising in the skull and spine. Exclusion Criteria: Prior or simultaneous malignancies within the past two years (other than cutaneous squamous or basal cell carcinoma, melanoma in situ or thyroid carcinoma) Patients with the following histologies are excluded: melanoma , other soft tissue or bony sarcomas, giant cell tumor aneurismal bone cyst or metastatic lesions from other histologies. Pregnant women. Actively being treated on any other therapeutic research study. Tumors arising outside of the CNS.

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Proton group<br>Proton radiation total dose 72.00 to 79.2 Gy(RBE) in 40-44 fractions | Radiation: Proton Therapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of proton RT for chordomas and chondrosarcomas | Treatment completion | Up to 10 days | 
| Acute Toxicity | Any grade 3 or higher toxicity observed within 90 days from start of therapy. | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Late toxicity | Any grade 3 or higher toxicty observed later than 90 days from completion of therapy. | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Age 18 or greater, No prior radiation