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

Chondrosarcoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00592748
• Other study ID #: 97-553
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: December 28, 2007
• Last updated: June 14, 2017
• Start date: June 1999
• Est. completion date: May 2015

Study information

• Verified date: June 2017
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 381
• Est. completion date: May 2015
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chondrosarcoma
• Chordoma

Intervention

Radiation:
• Charged Particle Radiation Therapy
Radiation doses will be determined by planning CT

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute Toxicity		90 days
Secondary	Establish local control rates for both dose schedules.		5 years
Secondary	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.		5 years
Secondary	Late Toxicity		5 Years