Charged Particle RT for Chordomas and Chondrosarcomas of the Base of Skull or Cervical Spine - Full Text View

Sponsored by:	Massachusetts General Hospital
Information provided by:	Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00592748

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 I Phase II

MedlinePlus related topics: Cancer Neck Injuries and Disorders

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	Randomized Study of Charged Particle RT for Chordomas and Chondrosarcomas of the Base of Skull or Cervical Spine

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
Group 1: Active Comparator 40-44 Treatments	Radiation: Charged Particle Radiation Therapy Radiation doses will be determined by planning CT
Group 2: Active Comparator 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

Responsible Party:	Massachusetts General Hospital ( John E. Munzenrider, MD )
Study ID Numbers:	97-533
Study First Received:	December 28, 2007
Last Updated:	January 11, 2008
ClinicalTrials.gov Identifier:	NCT00592748
Health Authority:	United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:

charged particle radiation therapy

Study placed in the following topic categories:

Neoplasms, Connective and Soft Tissue
Malignant mesenchymal tumor
Neoplasms, Germ Cell and Embryonal
Chondrosarcoma

Sarcoma
Chordoma
Soft tissue sarcomas

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Neoplasms, Connective Tissue

ClinicalTrials.gov processed this record on January 16, 2009