Proton Radiation for Chordomas and Chondrosarcomas

Not Applicable

Active, not recruiting

• Conditions: Chondrosarcomas; Chordomas
• Interventions: Radiation: Proton Therapy

• Registration Number: NCT01449149
• Lead Sponsor: Abramson Cancer Center at Penn Medicine

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 Timeline

• Study Start: 2010-03
• Study First Submitted: 2011-10-04
• Study First Submitted QC: 2011-10-06
• Study First Posted: 2011-10-10
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-25
• Last Update Posted: 2024-06-26
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Proton group	Proton Therapy	Proton radiation total dose 72.00 to 79.2 Gy(RBE) in 40-44 fractions

Primary Outcome Measures

Name	Time	Method
Feasibility of proton RT for chordomas and chondrosarcomas	Up to 10 days	Treatment completion
Acute Toxicity	90 days	Any grade 3 or higher toxicity observed within 90 days from start of therapy.

Secondary Outcome Measures

Name	Time	Method
Late toxicity	90 days	Any grade 3 or higher toxicty observed later than 90 days from completion of therapy.

Trial Locations

Locations (1)

Abramson Cancer Center of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States