Proton Radiotherapy for Extremity Soft Tissue Sarcoma
Condition: Soft Tissue Sarcoma of the Extremities
MeSH terms: Sarcoma
Intervention: Proton Therapy
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: scheduled to receive RT either pre- or postoperatively

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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

        Exclusion Criteria:

          -  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.