The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Proton Radiation for Chordomas and Chondrosarcomas

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.
 
ClinicalTrials.gov Identifier: NCT01449149
Recruitment Status : Active, not recruiting
First Posted : October 10, 2011
Last Update Posted : June 22, 2023
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center at Penn Medicine

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Proton Radiation For Chordomas and Chondrosarcomas
Actual Study Start Date : March 2010
Estimated Primary Completion Date : December 2026
Estimated Study Completion Date : December 2026

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Chordoma

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Locations
Layout table for location information
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Abramson Cancer Center at Penn Medicine
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Abramson Cancer Center at Penn Medicine
ClinicalTrials.gov Identifier: NCT01449149    
Other Study ID Numbers: UPCC 01310
First Posted: October 10, 2011    Key Record Dates
Last Update Posted: June 22, 2023
Last Verified: June 2023
Keywords provided by Abramson Cancer Center at Penn Medicine:
Age 18 or greater
No prior radiation
Additional relevant MeSH terms:
Layout table for MeSH terms
Chondrosarcoma
Chordoma
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
 Neoplasms by Histologic Type
Neoplasms
Sarcoma
Neoplasms, Germ Cell and Embryonal