Trial Outcomes & Findings for Whole Lung IMRT in Children and Adults With Synovial Sarcoma and Lung Metastases (NCT NCT02181829)
NCT ID: NCT02181829
Last Updated: 2021-06-29
Results Overview
The CTCAE version 4.0 scale will be used. The radiation oncologist will score toxicity at each visit.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
10 participants
Primary outcome timeframe
within 3 months of the completion of treatment or 3 months following the completion of treatment.
Results posted on
2021-06-29
Participant Flow
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Whole Lung IMRT in Children and Adults With Synovial Sarcoma and Lung Metastases
Baseline characteristics by cohort
| Measure |
Whole Lung IMRT
n=10 Participants
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.
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|---|---|
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Age, Continuous
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38 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
10 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Whole Lung IMRT
n=10 Participants
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.
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|---|---|
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Number of Participants Evaluated for Toxicity
|
10 Participants
|
SECONDARY outcome
Timeframe: pre-treatment, 3 and 6 months (+/- 3 weeks) and at 12, 18, and 24 months (+/- 6 weeks) post-treatmentPopulation: Data were not collected
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: two-year follow-upPopulation: Data were not collected
Overall survival rates will be estimated by the Kaplan-Meier method.
Outcome measures
Outcome data not reported
Adverse Events
Whole Lung IMRT
Serious events: 0 serious events
Other events: 10 other events
Deaths: 7 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Whole Lung IMRT
n=10 participants at risk
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.
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|---|---|
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Gastrointestinal disorders
Nausea
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50.0%
5/10 • Up to 6 months after first treatment
|
|
General disorders
Fatigue
|
40.0%
4/10 • Up to 6 months after first treatment
|
|
Gastrointestinal disorders
Esophagitis
|
30.0%
3/10 • Up to 6 months after first treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
1/10 • Up to 6 months after first treatment
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
10.0%
1/10 • Up to 6 months after first treatment
|
|
Gastrointestinal disorders
Dysphagia
|
10.0%
1/10 • Up to 6 months after first treatment
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|
Investigations
Platelet count decreased
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10.0%
1/10 • Up to 6 months after first treatment
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|
Investigations
White blood cell decreased
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10.0%
1/10 • Up to 6 months after first treatment
|
Additional Information
Suzanne Wolden, MD
Memorial Sloan Kettering Cancer Center
Phone: 212-639-5148
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place