Proton Radiation for Chordomas and Chondrosarcomas

Abramson Cancer Center at Penn Medicine

Status: Active, not recruiting

Conditions: Chondrosarcomas; Chordomas

Treatments: Radiation: Proton Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01449149

UPCC 01310

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Proton group

Experimental group

Description:

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

Treatment:

Radiation: Proton Therapy