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

NCT00592748 | Completed Phase 1 DMC

• 1 other identifier: 97-553
• Study Type: interventional
• Target: 381
• Locations: 1 country
• Sites: 1

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.

Conditions

Chordoma; Chondrosarcoma

Keywords

charged particle radiation therapy

Outcome Measures

Primary Outcomes (1)

• Acute Toxicity

  90 days

Secondary Outcomes (3)

• Establish local control rates for both dose schedules.

  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.

  5 years

• Late Toxicity

  5 Years

Study Arms (2)

Group 1

ACTIVE COMPARATOR

40-44 Treatments

Radiation: Charged Particle Radiation Therapy

Group 2

ACTIVE COMPARATOR

37-40 Treatments

Radiation: Charged Particle Radiation Therapy

Interventions

Charged Particle Radiation Therapy RADIATION

Radiation doses will be determined by planning CT

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years of age or older
• Karnofsky Performance Status \> 50
• Neurologic Function of I or II
• No evidence of metastases

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Chordoma; Chondrosarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Sarcoma

Study Officials

• Norbert J. Liebsch, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Skull-Based Service

Study Record Dates

• First Submitted: December 28, 2007
• First Posted: January 14, 2008
• Study Start: June 1, 1999
• Primary Completion: July 1, 2007
• Study Completion: May 1, 2015
• Last Updated: June 16, 2017

Record last verified: 2017-06

Locations

US (1)