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Proton Radiation for Chordomas and Chondrosarcomas

This study is currently recruiting participants.
Verified December 2015 by Abramson Cancer Center of the University of Pennsylvania
Sponsor:
ClinicalTrials.gov Identifier:
NCT01449149
First Posted: October 10, 2011
Last Update Posted: December 8, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania
October 4, 2011
October 10, 2011
December 8, 2015
March 2010
July 2016   (Final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01449149 on ClinicalTrials.gov Archive Site
Late toxicity [ Time Frame: 90 days ]
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
July 2016
July 2016   (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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Michelle Alonso-Basanta, MD, PhD 855-216-0098 PennCancerTrials@emergingmed.com
United States
 
 
NCT01449149
UPCC 01310
Yes
Not Provided
Not Provided
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
December 2015

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