Clinical trial NCT02181829: Whole Lung IMRT in Children and Adults With Synovial Sarcoma and Lung Metastases
Official title: Whole Lung IMRT in Children and Adults With Synovial Sarcoma and Lung Metastases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Synovial Sarcoma
Single or Multiple Lung Metastases
Keywords: Whole Lung IMRT
14-075
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2014-07-04
Enrollment: 10
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


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 \< 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.

Primary outcomes:
measure: Number of Participants Evaluated for Toxicity
timeFrame: within 3 months of the completion of treatment or 3 months following the completion of treatment.
Secondary outcomes:
measure: Pulmonary Failure-free Survival
timeFrame: pre-treatment, 3 and 6 months (+/- 3 weeks) and at 12, 18, and 24 months (+/- 6 weeks) post-treatment
measure: Rates of Overall Survival (OS)
timeFrame: two-year follow-up
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Commack
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Rockville Centre
country: United States
facility: Memorial Sloan Kettering Rockville Centre
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Suzanne Wolden, MD
role: PRINCIPAL_INVESTIGATOR
References: