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

Completed · Phase 1/Phase 2

Conditions studied: Chordoma, Chondrosarcoma

In brief

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.

Key facts

Study ID

NCT00592748

Run by

Massachusetts General Hospital

People needed

381

Starts

1999-06-01

Expected to finish

2015-05-01

Last updated by the study team

2017-06-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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