Clinical Trial: Proton Radiation for Chordomas and Chondrosarcomas

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Proton Radiation For Chordomas and Chondrosarcomas

Brief Summary: The objectives of this study are 1) To evaluate the feasibility and acute side effects of proton therapy for chordomas and chondrosarcomas and 2) To evaluate clinical outcomes and long term side effects of proton beam radiation for treatment of chordomas and chondrosarcomas.

Detailed Summary: This trial will be conducted in two phases: a feasibility then a phase II trial. Once feasibility and safety are established in the first 12 pts. the phase II study will begin. Proton therapy at standard doses is not known to improve clinical outcome but will likely reduce fatigue and toxicity.
Sponsor: Abramson Cancer Center of the University of Pennsylvania

Current Primary Outcome:

  • Feasibility [ Time Frame: Up to 10 days ]
    patient is unable to complete all of his/her treatments with 10 days of estimated date of treatment completion or requires a treatment breaks greater than 5 days.
  • Acute Toxicity [ Time Frame: 90 days ]
    Any grade 3 or higher toxicty observed within 90 days from start of therapy.


Original Primary Outcome: Same as current

Current Secondary Outcome: Late toxicity [ Time Frame: 90 days ]

Any grade 3 or higher toxicty observed later than 90 days from completion of therapy.


Original Secondary Outcome: Same as current

Information By: Abramson Cancer Center of the University of Pennsylvania

Dates:
Date Received: October 4, 2011
Date Started: March 2010
Date Completion: July 2016
Last Updated: December 7, 2015
Last Verified: December 2015