Proton Radiation for Chordomas and Chondrosarcomas

This study is currently recruiting participants.
Verified August 2013 by Abramson Cancer Center of the University of Pennsylvania
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01449149
First received: October 4, 2011
Last updated: August 20, 2013
Last verified: August 2013

October 4, 2011
August 20, 2013
March 2010
March 2014   (final data collection date for primary outcome measure)
  • Feasibility [ Time Frame: Up to 10 days ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Any grade 3 or higher toxicty observed within 90 days from start of therapy.
Same as current
Complete list of historical versions of study NCT01449149 on ClinicalTrials.gov Archive Site
Late toxicity [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
Any grade 3 or higher toxicty observed later than 90 days from completion of therapy.
Same as current
Not Provided
Not Provided
 
Proton Radiation for Chordomas and Chondrosarcomas
Proton Radiation For Chordomas and Chondrosarcomas

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.

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.

Interventional
Phase 1
Phase 2
Primary Purpose: Treatment
  • Chordomas
  • Chondrosarcomas
Radiation: Proton Therapy
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
March 2014
March 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically confirmed diagnosis of chordoma or chondrosarcoma.
  • Patients must have no evidence of metastatic disease based on routine imaging (CT or MRI of the chest/abdomen/pelvis, bone scan, etc.)
  • Patients must have an ECOG score equal to or less than 2.
  • Age ≥ 18 years.
  • Patients must be able to provide informed consent.
  • Adequate bone marrow function: WBC ≥ 4000/mm3, platelets ≥ 100, 000mm3
  • Women of child-bearing potential as long as she agrees to use a recognized method of birth control (e.g. oral contraceptive , IUD, condoms or other barrier methods etc.) Hysterectomy or menopause must be clinically documented.
  • Tumors arising in the skull and spine.

Exclusion Criteria:

  • Prior or simultaneous malignancies within the past two years (other than cutaneous squamous or basal cell carcinoma, melanoma in situ or thyroid carcinoma)
  • Patients with the following histologies are excluded: melanoma , other soft tissue or bony sarcomas, giant cell tumor aneurismal bone cyst or metastatic lesions from other histologies.
  • Pregnant women.
  • Actively being treated on any other therapeutic research study.
  • Tumors arising outside of the CNS.
Both
18 Years and older
No
Contact: Michelle Alonso-Basanta, MD, PhD 855-216-0098 PennCancerTrials@emergingmed.com
United States
 
NCT01449149
UPCC 01310
Yes
Abramson Cancer Center of the University of Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Not Provided
Not Provided
Abramson Cancer Center of the University of Pennsylvania
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP