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Completed

NCT Number: NCT00592748

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Charged Particle Radiation Therapy

Radiation

Radiation doses will be determined by planning CT

Primary outcomes

  1. Acute Toxicity

    Time frame: 90 days

Secondary outcomes

  1. Establish local control rates for both dose schedules.

    Time frame: 5 years

  2. 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

  3. Late Toxicity

    Time frame: 5 Years

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
1999
Primary completion
2007
Study completion
2015
First posted
Jan 14, 2008
Registry last updated
Jun 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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