Back to resultsWhole Lung IMRT in Children and Adults With Synovial Sarcoma and Lung Metastases
Primary Purpose
Synovial Sarcoma, Single or Multiple Lung Metastases
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Whole Lung IMRT
Sponsored by
About this trial
This is an interventional treatment trial for Synovial Sarcoma focused on measuring Whole Lung IMRT, 14-075
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.
Sites / Locations
- Memorial Sloan Kettering Basking Ridge
- Memorial Sloan Kettering Commack
- Memorial Sloan Kettering Westchester
- Memorial Sloan Kettering Cancer Center
- Memorial Sloan Kettering Rockville Centre
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Whole Lung IMRT
Arm Description
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.
Outcomes
Primary Outcome Measures
Number of Participants Evaluated for Toxicity
The CTCAE version 4.0 scale will be used. The radiation oncologist will score toxicity at each visit.
Secondary Outcome Measures
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.
Rates of Overall Survival (OS)
Overall survival rates will be estimated by the Kaplan-Meier method.
Full Information
NCT ID
NCT02181829
First Posted
July 2, 2014
Last Updated
June 7, 2021
Sponsor
Memorial Sloan Kettering Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT02181829
Brief Title
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
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
June 24, 2020 (Actual)
Study Completion Date
June 24, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Synovial Sarcoma, Single or Multiple Lung Metastases
Keywords
Whole Lung IMRT, 14-075
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Whole Lung IMRT
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
Whole Lung IMRT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants Evaluated for Toxicity
Description
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.
Secondary Outcome Measure Information:
Title
Pulmonary Failure-free Survival
Description
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
Title
Rates of Overall Survival (OS)
Description
Overall survival rates will be estimated by the Kaplan-Meier method.
Time Frame
two-year follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzanne Wolden, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Basking Ridge
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Facility Name
Memorial Sloan Kettering Commack
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Facility Name
Memorial Sloan Kettering Westchester
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Memorial Sloan Kettering Rockville Centre
City
Rockville Centre
State/Province
New York
ZIP/Postal Code
11570
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.mskcc.org/
Description
Memorial Sloan Kettering Cancer Center
Learn more about this trial
Whole Lung IMRT in Children and Adults With Synovial Sarcoma and Lung Metastases
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