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

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.

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Key information

Conditions

Synovial Sarcoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Sarcoma Sarcoma, Synovial Single or Multiple Lung Metastases

Age range

1 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Memorial Sloan Kettering Basking Ridge, Basking Ridge, New Jersey, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Whole Lung IMRT

Radiation

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.

Primary outcomes

Number of Participants Evaluated for Toxicity

Time frame: within 3 months of the completion of treatment or 3 months following the completion of treatment.

The CTCAE version 4.0 scale will be used. The radiation oncologist will score toxicity at each visit.

Secondary outcomes

Pulmonary Failure-free Survival

Time frame: pre-treatment, 3 and 6 months (+/- 3 weeks) and at 12, 18, and 24 months (+/- 6 weeks) post-treatment

A CT scan of the chest will be obtained. This study will use a modified Response Evaluation Criteria in Solid Tumor (RECIST) for assessment of tumor response. Pulmonary failure-free survival will be defined as survival with no progressive disease in the lungs.
Rates of Overall Survival (OS)

Time frame: two-year follow-up

Overall survival rates will be estimated by the Kaplan-Meier method.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Important dates

Study start: 2014
Primary completion: 2020
Study completion: 2020
First posted: Jul 4, 2014
Registry last updated: Jun 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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