Whole Lung IMRT in Children and Adults With Synovial Sarcoma and Lung Metastases
Condition: Synovial Sarcoma; Single or Multiple Lung Metastases
MeSH terms: Neoplasm Metastasis; Sarcoma; Sarcoma, Synovial; Lung Neoplasms
Intervention: Whole Lung IMRT
Intervention description: External beam radiation therapy will be administered on an outpatient basis, once daily (except weekends and holidays) for approximately two weeks. Patients will undergo a simulation prior to initiation of radiation. Once an IMRT plan is generated which meets all dose constraints specified patients will be treated with 6MV photons for 10 treatments.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 1 Year
Healthy volunteers: No
Keywords: Whole Lung IMRT; 14-075

Summary:

      The purpose of this study is to find out what effects, good and/or bad, radiation has on the
      lungs has on the patient and on synovial sarcoma which has spread to the lungs. The standard
      treatment for synovial sarcoma which has spread to the lungs is chemotherapy with or without
      surgery to remove the tumors in the lungs. However, tumors often come back in the lungs after
      chemotherapy and/or surgery. Since synovial sarcoma is known to be sensitive to radiation,
      this study is looking at whether radiation therapy which is targeted to the entire lung can
      further reduce the chances of the cancer returning. This type of radiation is commonly used
      in other types of sarcoma to treat the cancer once it has spread to the lungs and it may be
      very useful in synovial sarcoma as well.

      In this study, a special type of radiation will be used, called Intensity Modulated Radiation
      Therapy (IMRT). With IMRT the radiation beams are more customized to focus more radiation on
      the tumor cells while delivering less radiation to areas like the heart. The goal of this
      study is also to measure pulmonary toxicity and see if IMRT is feasible and has less
      toxicity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with synovial sarcoma confirmed by MSKCC pathological review

          -  Patients with single or multiple lung metastases at diagnosis or that develop over the
             course of treatment. After completion of all chemotherapy, lung metastases or must be
             ≤ 2cm.

          -  Age ≥12 months of age

          -  Karnofsky performance status (KPS) must be ≥ 70 for patients ≥ 16 years of age and
             Lansky performance status must be ≥ 70 for patients < 16 years of age.

          -  Normal cardiac function

          -  No active coronary artery disease;

          -  No New York Heart Association class II, III or IV disease;

          -  No arrhythmia requiring treatment.

          -  Baseline echocardiogram with a shortening fraction of ≥27% or an ejection fraction ≥
             50%.

          -  Female patients of childbearing potential must have a negative pregnancy test within
             14 days of radiation start.

          -  Female patients who are lactating must agree to stop breast-feeding.

          -  Sexually active patients of childbearing potential must agree to use effective
             contraception.

        Exclusion Criteria:

          -  Patients with a history of prior radiation therapy to the thorax.

          -  Patients requiring a field size >40 cm as IMRT cannot be performed at extended SSDs.

          -  Patients with any concurrent medical or psychiatric condition or disease which, in the
             investigator's judgment, would make them inappropriate candidates for entry into this
             study.