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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):

December 28, 2007
January 14, 2008
June 16, 2017
June 1999
July 2007   (Final data collection date for primary outcome measure)
Acute Toxicity [ Time Frame: 90 days ]
Establish acute and late toxicity rates for the different dose schedules. [ Time Frame: 5 years ]
Complete list of historical versions of study NCT00592748 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Late Toxicity [ Time Frame: 5 Years ]
  • 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 ]
Not Provided
Not Provided
 
Charged Particle RT for Chordomas and Chondrosarcomas of the Base of Skull or Cervical Spine
Randomized Study of Charged Particle RT for Chordomas and Chondrosarcomas of the Base of Skull or Cervical Spine
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.
  • 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.
Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Chordoma
  • Chondrosarcoma
Radiation: Charged Particle Radiation Therapy
Radiation doses will be determined by planning CT
  • Active Comparator: Group 1
    40-44 Treatments
    Intervention: Radiation: Charged Particle Radiation Therapy
  • Active Comparator: Group 2
    37-40 Treatments
    Intervention: Radiation: Charged Particle Radiation Therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
381
May 2015
July 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00592748
97-553
Yes
Not Provided
Not Provided
Norbert J. Liebsch, M.D., Massachusetts General Hospital
Massachusetts General Hospital
Not Provided
Principal Investigator: Norbert J. Liebsch, MD Massachusetts General Hospital
Massachusetts General Hospital
June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP