Proton Radiation for Chordomas and Chondrosarcomas

Abramson Cancer Center at Penn Medicine54 enrolled

Overview

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.

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

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chordomas Chondrosarcomas

Interventions

Proton TherapyRADIATION

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

Feasibility of Proton RT for Chordomas and Chondrosarcomas

The purpose of this study was to evaluate the feasibility and safety of dose-escalated proton beam therapy for treating chordomas and chondrosarcomas of the skull base and spine. The feasibility, as defined by ≥10% of patients experiencing either: unsatisfactory dosimetry, inability to complete all of his/her treatments within 10 days of estimated completion date and requiring no break \>5 days, and no greater than 20% of patients experiencing ≥grade 3 toxicity from RT.

Time frame: From enrollment to treatment completion or withdrawal, whichever occurred first, assessed up to 133 months

Secondary Outcomes

Acute Toxicities

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

Time frame: With in the 90 days from tx start date

Late Toxicities

Any grade 3 or higher toxicity observed later than 90 days from completion of therapy. Timepoints included below: Approx. 90 days from tx start. Follow-Up Months (approximately from completion of treatment) 3,6,9,12,15, 18, 21, 24 (approx.) Months 30, 36 (approximately from completion of treatment) Year 4 and 5 (approximately from completion of treatment)

Time frame: Every 3 months for 3 Years from the tx start date and assessed up to 133 months

Data from ClinicalTrials.gov

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