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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Massachusetts General Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00592748
First received: December 28, 2007
Last updated: August 7, 2009
Last verified: August 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Chordoma
Chondrosarcoma
 Radiation: Charged Particle Radiation Therapy
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Study of Charged Particle RT for Chordomas and Chondrosarcomas of the Base of Skull or Cervical Spine

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Establish acute and late toxicity rates for the different dose schedules. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Establish local control rates for both dose schedules. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 274
Study Start Date: June 1999
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group 1
40-44 Treatments
 Radiation: Charged Particle Radiation Therapy
Radiation doses will be determined by planning CT
Active Comparator: Group 2
37-40 Treatments
 Radiation: Charged Particle Radiation Therapy
Radiation doses will be determined by planning CT

Detailed 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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00592748

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: John E. Munzenrider, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: John E. Munzenrider, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00592748     History of Changes
Other Study ID Numbers: 97-533
Study First Received: December 28, 2007
Last Updated: August 7, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
charged particle radiation therapy

Additional relevant MeSH terms:
Chondrosarcoma
Chordoma
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
 Neoplasms by Histologic Type
Neoplasms
Sarcoma
Neoplasms, Germ Cell and Embryonal

ClinicalTrials.gov processed this record on June 17, 2013