Charged Particle RT for Chordomas and Chondrosarcomas of the Base of Skull or Cervical Spine
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
381 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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