This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Norbert J. Liebsch, M.D., Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00592748
First received: December 28, 2007
Last updated: June 14, 2017
Last verified: June 2017
  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
Intervention Model: Parallel Assignment
Masking: No masking
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:


Further study details as provided by Norbert J. Liebsch, M.D., Massachusetts General Hospital:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 381
Study Start Date: June 1999
Study Completion Date: May 2015
Primary Completion Date: July 2007 (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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Norbert J. Liebsch, MD Massachusetts General Hospital
  More Information

Responsible Party: Norbert J. Liebsch, M.D., Director, Skull-Based Service, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00592748     History of Changes
Other Study ID Numbers: 97-553
Study First Received: December 28, 2007
Last Updated: June 14, 2017

Keywords provided by Norbert J. Liebsch, M.D., 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 28, 2017