Clinical Trial: Charged Particle RT for Chordomas and Chondrosarcomas of the Base of Skull or Cervical Spine
Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Randomized Study of Charged Particle RT for Chordomas and Chondrosarcomas of the Base of Skull or Cervical Spine
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 Summary:
- 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.
Sponsor: Massachusetts General Hospital
Current Primary Outcome: Establish acute and late toxicity rates for the different dose schedules. [ Time Frame: 5 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Establish local control rates for both dose schedules. [ Time Frame: 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. [ Time Frame: 5 years ]
Original Secondary Outcome: Same as current
Information By: Massachusetts General Hospital
Dates:
Date Received: December 28, 2007
Date Started: June 1999
Date Completion:
Last Updated: August 7, 2009
Last Verified: August 2009
