Proton Radiation for Chordomas and Chondrosarcomas

NCT ID: NCT01449149

Last Updated: 2025-12-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2025-09-04

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.

Conditions

Chordomas; Chondrosarcomas

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Proton group

Proton radiation total dose 72.00 to 79.2 Gy(RBE) in 40-44 fractions

Group Type: EXPERIMENTAL

Proton Therapy

Intervention Type: RADIATION

Interventions

Proton Therapy

Intervention Type: RADIATION

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abramson Cancer Center at Penn Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

UPCC 01310

Identifier Type: -

Identifier Source: org_study_id