Whole Lung IMRT in Children and Adults With Synovial Sarcoma and Lung Metastases

Completed · Phase 2

Conditions studied: Synovial Sarcoma, Single or Multiple Lung Metastases

In brief

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.

Key facts

Study ID

NCT02181829

Run by

Memorial Sloan Kettering Cancer Center

People needed

10

Starts

2014-07-01

Expected to finish

2020-06-24

Last updated by the study team

2021-06-29

Who can join

Age: 1 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Memorial Sloan Kettering Basking Ridge — Basking Ridge, New Jersey, United States
• Memorial Sloan Kettering Commack — Commack, New York, United States
• Memorial Sloan Kettering Westchester — Harrison, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Memorial Sloan Kettering Rockville Centre — Rockville Centre, New York, United States

Full record on ClinicalTrials.gov

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