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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 May 2022 |
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Main ID: |
NCT02561559 |
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Date of registration:
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25/09/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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SBRT Treatment for Lung Metastasis From Soft Tissue Sarcoma
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Scientific title:
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Phase II Study to Evaluate Feasibility and Safety of Stereotactic Body Radiation Radiotherapy (SBRT) for Lung Metastases From Soft Tissue Sarcoma |
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Date of first enrolment:
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June 10, 2015 |
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Target sample size:
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37 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02561559 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Italy
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Contacts
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Name:
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Marta Scorsetti, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Istituto Clinico Humanitas |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age 18 anni -85 years
- PS according to ECOG 0-2
- Histopathologically confirmation of soft tissue sarcoma
- Metastatic lung lesion less than 4
- Controlled primary tumor and other metastatic lesions
- Metastatic lesion less than 5 such as the definition of oligometastatic patients
- Written informed consent
- Contraindication to surgical resection
- Estimated survival = 3 months
- Absence of progressive disease longer than 6 months
- No chemotherapy was given for at least 3 months after SBRT
- Maximum diameter = 5 cm
Exclusion Criteria:
- Prior thorax radiation therapy
- Age > 85 years
- PS according to ECOG >2
- Pregnant women
- Maximum diameter = 5.1 cm
- Total volume of lung lesion greater than 1/3 of the whole pulmonary parenchima
Age minimum:
18 Years
Age maximum:
85 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Metastasis From Malignant Tumor of Soft Tissues
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Intervention(s)
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Radiation: Lung metastasis from soft-tissue sarcoma
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Primary Outcome(s)
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Local control of treated lesions
[Time Frame: 12 months]
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Secondary Outcome(s)
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Overall survival of treated patients
[Time Frame: 4 years]
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Disease free survival of treated patients
[Time Frame: 4 years]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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