Proton Radiation for Chordomas and Chondrosarcomas

• Sponsor: Abramson Cancer Center of the University of Pennsylvania (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT01449149
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 201
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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	N/A

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

• Study Type: Interventional
• Anticipated 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: Mar 1, 2010
• Anticipated Primary Completion Date: Dec 1, 2026
• Anticipated Study Completion Date: Dec 1, 2026

Arms and Interventions

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

Primary Outcome Measures

1. Feasibility of proton RT for chordomas and chondrosarcomas [Up to 10 days]

   Treatment completion

2. Acute Toxicity [90 days]

   Any grade 3 or higher toxicity observed within 90 days from start of therapy.

Secondary Outcome Measures

1. Late toxicity [90 days]

   Any grade 3 or higher toxicty observed later than 90 days from completion of therapy.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

• Abramson Cancer Center of the University of Pennsylvania

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abramson Cancer Center of the University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT01449149
• Other Study ID Numbers: UPCC 01310
• First Posted: Oct 10, 2011
• Last Update Posted: Jun 3, 2022
• Last Verified: Jun 1, 2022

• Keywords provided by Abramson Cancer Center of the University of Pennsylvania: Age 18 or greater; No prior radiation
• Additional relevant MeSH terms: Chondrosarcoma; Chordoma

Study Results

No Results Posted as of Jun 3, 2022