Single or Multiple Lung Metastases, Synovial Sarcoma
Conditions
Keywords
Whole Lung IMRT, 14-075
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.
Interventions
RADIATIONWhole 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.
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Evaluated for Toxicity | 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
| Measure | Time frame | Description |
|---|---|---|
| Pulmonary Failure-free Survival | 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) | two-year follow-up | Overall survival rates will be estimated by the Kaplan-Meier method. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Whole Lung IMRT This is a single institution study involving patients with synovial sarcoma who have completed all standard therapy (e.g. surgery +/- radiation to the primary site) +/- any adjuvant chemotherapy. The sequence and types of therapy offered prior to WLI will likely vary based on primary tumor site, tumor resectability, extent of metastatic disease, performance status, and comorbidity. Each patient's therapy will be determined by the disease management team irrespective of participation on this protocol.
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. | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Whole Lung IMRT |
|---|---|
| Age, Continuous | 38 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 7 Participants |
| Region of Enrollment United States | 10 Participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 7 / 10 |
| other Total, other adverse events | 10 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
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.
Time frame: within 3 months of the completion of treatment or 3 months following the completion of treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Whole Lung IMRT | Number of Participants Evaluated for Toxicity | 10 Participants |
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.
Time frame: pre-treatment, 3 and 6 months (+/- 3 weeks) and at 12, 18, and 24 months (+/- 6 weeks) post-treatment
Population: Data were not collected
Secondary
Rates of Overall Survival (OS)
Overall survival rates will be estimated by the Kaplan-Meier method.
Time frame: two-year follow-up
Population: Data were not collected