Overview

This trial is active, not recruiting.

Conditions chordoma, chondrosarcoma
Treatment charged particle radiation therapy
Phase phase 1/phase 2
Sponsor Massachusetts General Hospital
Start date June 1999
End date January 2006
Trial size 274 participants
Trial identifier NCT00592748, 97-533

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
40-44 Treatments
charged particle radiation therapy
Radiation doses will be determined by planning CT
(Active Comparator)
37-40 Treatments
charged particle radiation therapy
Radiation doses will be determined by planning CT

Primary Outcomes

Measure
Establish acute and late toxicity rates for the different dose schedules.
time frame: 5 years

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Randomized Study of Charged Particle RT for Chordomas and Chondrosarcomas of the Base of Skull or Cervical Spine
Principal investigator John E. Munzenrider, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2009.
Information provided to ClinicalTrials.gov by Massachusetts General Hospital.