Proton Radiation for Chordomas and Chondrosarcomas

This study is ongoing, but not recruiting participants.

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: February 25, 2013

Last verified: February 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	October 4, 2011
Last Updated Date	February 25, 2013
Start Date ^ICMJE	March 2010
Estimated Primary Completion Date	March 2014 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 6, 2011)	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.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01449149 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: October 6, 2011)	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.
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Proton Radiation for Chordomas and Chondrosarcomas
Official Title ^ICMJE	Proton Radiation For Chordomas and Chondrosarcomas
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.
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 Type ^ICMJE	Interventional
Study Phase	Phase 1 Phase 2
Study Design ^ICMJE	Primary Purpose: Treatment
Condition ^ICMJE	Chordomas Chondrosarcomas
Intervention ^ICMJE	Radiation: Proton Therapy
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	50
Estimated Completion Date	March 2014
Estimated Primary Completion Date	March 2014 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01449149
Other Study ID Numbers ^ICMJE	UPCC 01310
Has Data Monitoring Committee	Yes
Responsible Party	Abramson Cancer Center of the University of Pennsylvania
Study Sponsor ^ICMJE	Abramson Cancer Center of the University of Pennsylvania
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Abramson Cancer Center of the University of Pennsylvania
Verification Date	February 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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