CompletedPhase 2NCT02181829
Official study title

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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedWhole Lung IMRT

The study team can explain what participation involves.

Who it may be forSynovial Sarcoma · Single or Multiple Lung Metastases

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jun 29, 2021 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?5 U.S. locations

Locations may change over time.

Who runs it?Memorial Sloan Kettering Cancer Center

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Memorial Sloan Kettering Cancer Center
Interventions being studied
Radiation: Whole Lung IMRT
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.
Reasons someone may not be able to joinExclusion 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Memorial Sloan Kettering Basking RidgeBasking Ridge, New Jersey
  • Memorial Sloan Kettering CommackCommack, New York
  • Memorial Sloan Kettering WestchesterHarrison, New York
  • Memorial Sloan Kettering Cancer CenterNew York, New York
  • Memorial Sloan Kettering Rockville CentreRockville Centre, New York

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 29, 2021. Always confirm current availability with the study team.

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