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

Primary Purpose

Chordoma, Chondrosarcoma

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Charged Particle Radiation Therapy
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chordoma focused on measuring charged particle radiation therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group 1

Group 2

Arm Description

40-44 Treatments

37-40 Treatments

Outcomes

Primary Outcome Measures

Acute Toxicity

Secondary Outcome Measures

Establish local control rates for both dose schedules.
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.
Late Toxicity

Full Information

First Posted
December 28, 2007
Last Updated
June 14, 2017
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00592748
Brief Title
Charged Particle RT for Chordomas and Chondrosarcomas of the Base of Skull or Cervical Spine
Official Title
Randomized Study of Charged Particle RT for Chordomas and Chondrosarcomas of the Base of Skull or Cervical Spine
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
June 1999 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chordoma, Chondrosarcoma
Keywords
charged particle radiation therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
381 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
40-44 Treatments
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
37-40 Treatments
Intervention Type
Radiation
Intervention Name(s)
Charged Particle Radiation Therapy
Intervention Description
Radiation doses will be determined by planning CT
Primary Outcome Measure Information:
Title
Acute Toxicity
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Establish local control rates for both dose schedules.
Time Frame
5 years
Title
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
Title
Late Toxicity
Time Frame
5 Years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Norbert J. Liebsch, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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