Proton Radiotherapy for Extremity Soft Tissue Sarcoma

Stopped early · Phase 2

Conditions studied: Soft Tissue Sarcoma of the Extremities

In brief

This is a study of proton radiotherapy for the pre- or post- operative treatment of patients with extremity sarcoma. This study will treat patients in two dose groups: 1. patients receiving pre-operative proton therapy and 2. patients receiving post-operative proton therapy. In each dose group, the study is divided into two phases. In the first phase of the study, the investigators will determine if treatment with proton therapy is safe and can be delivered on a regular basis. In the second phase, the investigators will determine if proton therapy has less long term side effects compared to standard radiation in both pre-operative patients and post-operative patients.

Key facts

Study ID

NCT01561495

Run by

Abramson Cancer Center at Penn Medicine

People needed

1

Starts

2010-06-01

Expected to finish

2017-02-03

Last updated by the study team

2019-12-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with a histologic diagnosis of soft tissue sarcoma of the extremities are eligible for this study.
• Patient must be 18 years of age.
• Patients must have evidence of disease limited to the extremities.
• For the pre-operative group, patients must be considered operable/resectable and a candidate for pre-operative radiotherapy as judged by the attending surgeon and radiation oncologist. The clinical evaluation of patients will include a work up as per the standard of care. All patients in the pre-operative group will be evaluated for this protocol PRIOR to the initiation of therapy.
• For the post-operative group, patients must be considered operable/resectable (if evaluated prior to resection) and a candidate for post-operative radiotherapy by the attending surgeon and radiation oncologist. The clinical evaluation of patients will include a work up as per the standard of care. Patients in the post-operative group may be evaluated PRIOR to the initiation of any therapy or may be referred for evaluation after surgical resection.
• ECOG status of 0-2.
• Patients must sign a document that indicates that they are aware of the investigative nature of the treatment of this protocol, and the potential benefits and risks. Patients unwilling or unable to sign informed consent are excluded from the study.
• 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.
• Negative urine pregnancy test for females of childbearing potential on the day of the F18-EF5 PET scan prior to F18-EF5 injection

You may not qualify if…

• Pregnant women, women planning to become pregnant and women that are nursing.
• Patients who experience surgical complications that prevent radiation from starting for 5 months or more, unless there is evidence of gross residual disease.

Where it is running

• Abramson Cancer Center of the University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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