Phase 2
Completed N=10
Whole Lung IMRT in Children and Adults With Synovial Sarcoma and Lung Metastases
Synovial Sarcoma · Single or Multiple Lung Metastases
Source: ClinicalTrials.gov NCT02181829 ↗
Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Jun 2021
Primary outcomePrimary: Number of Participants Evaluated for Toxicity — 10 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Evaluated for Toxicity |
10 | — |
| SECONDARY Pulmonary Failure-free Survival |
— | — |
| SECONDARY Rates of Overall Survival (OS) |
— | — |
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 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.
Data sourced from ClinicalTrials.gov (NCT02181829). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.