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Proton Radiation for Chordomas and Chondrosarcomas

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ClinicalTrials.gov Identifier: NCT01449149
Recruitment Status : Recruiting
First Posted : October 10, 2011
Last Update Posted : April 12, 2019
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania

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.

Condition or disease Intervention/treatment Phase
Chordomas Chondrosarcomas Radiation: Proton Therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Proton Radiation For Chordomas and Chondrosarcomas
Study Start Date : March 2010
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Proton group
Proton radiation total dose 72.00 to 79.2 Gy(RBE) in 40-44 fractions
Radiation: Proton Therapy



Primary Outcome Measures :
  1. Feasibility of proton RT for chordomas and chondrosarcomas [ Time Frame: Up to 10 days ]
    Treatment completion

  2. Acute Toxicity [ Time Frame: 90 days ]
    Any grade 3 or higher toxicity observed within 90 days from start of therapy.


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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

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

Locations
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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

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Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01449149     History of Changes
Other Study ID Numbers: UPCC 01310
First Posted: October 10, 2011    Key Record Dates
Last Update Posted: April 12, 2019
Last Verified: April 2019

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

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