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

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ClinicalTrials.gov Identifier: NCT00592748
Recruitment Status : Completed
First Posted : January 14, 2008
Last Update Posted : June 16, 2017
Sponsor:
Information provided by (Responsible Party):
Norbert J. Liebsch, M.D., Massachusetts General Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Chordoma Chondrosarcoma Radiation: Charged Particle Radiation Therapy Phase 1 Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 381 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : June 1999
Actual Primary Completion Date : July 2007
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Chordoma

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Acute Toxicity [ Time Frame: 90 days ]

Secondary Outcome Measures :
  1. Establish local control rates for both dose schedules. [ Time Frame: 5 years ]
  2. 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 ]
  3. Late Toxicity [ Time Frame: 5 Years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00592748


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Norbert J. Liebsch, MD Massachusetts General Hospital
More Information
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Responsible Party: Norbert J. Liebsch, M.D., Director, Skull-Based Service, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00592748    
Other Study ID Numbers: 97-553
First Posted: January 14, 2008    Key Record Dates
Last Update Posted: June 16, 2017
Last Verified: June 2017
Keywords provided by Norbert J. Liebsch, M.D., Massachusetts General Hospital:
charged particle radiation therapy
Additional relevant MeSH terms:
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Chondrosarcoma
Chordoma
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
 Neoplasms by Histologic Type
Neoplasms
Sarcoma
Neoplasms, Germ Cell and Embryonal