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


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Chordoma, Chondrosarcoma

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Trial Information

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


- 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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Establish acute and late toxicity rates for the different dose schedules.

Outcome Time Frame:

5 years

Safety Issue:

Yes

Principal Investigator

John E. Munzenrider, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital

Authority:

United States: Institutional Review Board

Study ID:

97-533

NCT ID:

NCT00592748

Start Date:

June 1999

Completion Date:

Related Keywords:

  • Chordoma
  • Chondrosarcoma
  • charged particle radiation therapy
  • Chondrosarcoma
  • Chordoma

Name

Location

Massachusetts General HospitalBoston, Massachusetts  02114-2617