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

June 14, 2017 updated by: Norbert J. Liebsch, M.D., Massachusetts General Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

381

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Acute Toxicity
Time Frame: 90 days
90 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Establish local control rates for both dose schedules.
Time Frame: 5 years
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
5 years
Late Toxicity
Time Frame: 5 Years
5 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Investigators

  • Principal Investigator: Norbert J. Liebsch, MD, Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 1999

Primary Completion (Actual)

July 1, 2007

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

December 28, 2007

First Submitted That Met QC Criteria

January 11, 2008

First Posted (Estimate)

January 14, 2008

Study Record Updates

Last Update Posted (Actual)

June 16, 2017

Last Update Submitted That Met QC Criteria

June 14, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 97-553

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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