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

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00592748

Enrollment

381

Registered

2008-01-14

Start date

1999-06-30

Completion date

2015-05-31

Last updated

2017-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chondrosarcoma, Chordoma

Keywords

charged particle radiation therapy

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.

Interventions

RADIATIONCharged Particle Radiation Therapy

Radiation doses will be determined by planning CT

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Acute Toxicity	90 days

Secondary

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026