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Proton Radiation for Chordomas and Chondrosarcomas

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2015 by Abramson Cancer Center of the University of Pennsylvania.
Recruitment status was:  Recruiting
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. Read our disclaimer for details.
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania
  Purpose
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.

Condition Intervention Phase
Chordomas Chondrosarcomas Radiation: Proton Therapy Phase 1 Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Proton Radiation For Chordomas and Chondrosarcomas

Resource links provided by NLM:


Further study details as provided by Abramson Cancer Center of the University of Pennsylvania:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Late toxicity [ Time Frame: 90 days ]
    Any grade 3 or higher toxicty observed later than 90 days from completion of therapy.


Estimated Enrollment: 50
Study Start Date: March 2010
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01449149


Contacts
Contact: Michelle Alonso-Basanta, MD, PhD 855-216-0098 PennCancerTrials@emergingmed.com

Locations
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Michelle Alonso-Basanta, MD, PhD    855-216-0098    PennCancerTrials@emergingmed.com   
Principal Investigator: Michelle Alonso-Basanta, MD, PhD         
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
  More Information

Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01449149     History of Changes
Other Study ID Numbers: UPCC 01310
First Submitted: October 4, 2011
First Posted: October 10, 2011
Last Update Posted: December 8, 2015
Last Verified: December 2015

Keywords provided by Abramson Cancer Center of the University of Pennsylvania:
Age 18 or greater
No prior radiation

Additional relevant MeSH terms:
Chondrosarcoma
Chordoma
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Sarcoma
Neoplasms, Germ Cell and Embryonal