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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

381 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-06-30

Study Completion Date

2015-05-31

Brief Summary

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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.

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Detailed Description

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* 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.

Conditions

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Chordoma Chondrosarcoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 1

40-44 Treatments

Group Type ACTIVE_COMPARATOR

Charged Particle Radiation Therapy

Intervention Type RADIATION

Radiation doses will be determined by planning CT

Group 2

37-40 Treatments

Group Type ACTIVE_COMPARATOR

Charged Particle Radiation Therapy

Intervention Type RADIATION

Radiation doses will be determined by planning CT

Interventions

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Charged Particle Radiation Therapy

Radiation doses will be determined by planning CT

Intervention Type RADIATION

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No