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

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ClinicalTrials.gov Identifier: NCT02181829
Recruitment Status : Active, not recruiting
First Posted : July 4, 2014
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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.


Condition or disease Intervention/treatment Phase
Synovial Sarcoma Single or Multiple Lung Metastases Radiation: Whole Lung IMRT Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Whole Lung IMRT in Children and Adults With Synovial Sarcoma and Lung Metastases
Study Start Date : July 2014
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
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.




Primary Outcome Measures :
  1. overall toxicity rate [ Time Frame: 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 Outcome Measures :
  1. pulmonary failure-free survival [ Time Frame: 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.

  2. rates of overall survival (OS) [ Time Frame: two-year follow-up ]
    Overall survival rates will be estimated by the Kaplan-Meier method.



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Ages Eligible for Study:   1 Year and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02181829


Locations
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United States, New Jersey
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, United States, 07920
United States, New York
Memorial Sloan Kettering Commack
Commack, New York, United States, 11725
Memorial Sloan Kettering Westchester
Harrison, New York, United States, 10604
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Memorial Sloan Kettering Rockville Centre
Rockville Centre, New York, United States, 11570
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Suzanne Wolden, MD Memorial Sloan Kettering Cancer Center

Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02181829     History of Changes
Other Study ID Numbers: 14-075
First Posted: July 4, 2014    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018

Keywords provided by Memorial Sloan Kettering Cancer Center:
Whole Lung IMRT
14-075

Additional relevant MeSH terms:
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Sarcoma, Synovial
Neoplasm Metastasis
Sarcoma
Lung Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Connective Tissue
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases