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

Synovial Sarcoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02181829
• Other study ID #: 14-075
• Status: Completed
• Phase: Phase 2
• Start date: July 2014
• Est. completion date: June 24, 2020

Study information

• Verified date: June 2020
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 24, 2020
• Est. primary completion date: June 24, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Neoplasms
• Neoplasm Metastasis
• Sarcoma
• Sarcoma, Synovial
• Single or Multiple Lung Metastases
• Synovial Sarcoma

Intervention

Radiation:
• Whole Lung IMRT
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.

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Evaluated for Toxicity	The CTCAE version 4.0 scale will be used. The radiation oncologist will score toxicity at each visit.	within 3 months of the completion of treatment or 3 months following the completion of treatment.
Secondary	Pulmonary Failure-free Survival	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.	pre-treatment, 3 and 6 months (+/- 3 weeks) and at 12, 18, and 24 months (+/- 6 weeks) post-treatment
Secondary	Rates of Overall Survival (OS)	Overall survival rates will be estimated by the Kaplan-Meier method.	two-year follow-up

External Links

•   Memorial Sloan Kettering Cancer Center