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SBRT Treatment for Lung Metastasis From Soft Tissue Sarcoma

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ClinicalTrials.gov Identifier: NCT02561559
Recruitment Status : Recruiting
First Posted : September 28, 2015
Last Update Posted : October 24, 2018
Sponsor:
Information provided by (Responsible Party):
Michele Tedeschi, Istituto Clinico Humanitas

Brief Summary:
In this study the investigators treat PM oligometastatic patients with SBRT. Our objective is to evaluate rate of local control of treated lesions in patients treated with Intensity Modulated Radiation Therapy (IMRT) using Volumetric Modulated Arc Therapy (VMAT) for lung metastases from STS.

Condition or disease Intervention/treatment
Metastasis From Malignant Tumor of Soft Tissues Radiation: Lung metastasis from soft-tissue sarcoma

Detailed Description:

The investigators started to treat PM oligometastatic patients with Stereotactic Body Radiotherapy.

The investigators objective is to evaluate rate of local control of treated lesions in patients treated with Intensity Modulated Radiation Therapy (IMRT) using Volumetric Modulated Arc Therapy (VMAT) for lung metastases from soft-tissue sarcomas. Overall and disease free survival will be evaluated as secondary endpoints.


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Study Type : Observational
Estimated Enrollment : 44 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Phase II Study to Evaluate Feasibility and Safety of Stereotactic Body Radiation Radiotherapy (SBRT) for Lung Metastases From Soft Tissue Sarcoma
Actual Study Start Date : June 10, 2015
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Lung metastasis from soft-tissue sarcoma
Lung metastases from soft-tissue sarcoma
Radiation: Lung metastasis from soft-tissue sarcoma
Tretament based on Intensity Modulated Radiation Therapy (IMRT) using Volumetric Modulated Arc Therapy (VMAT)




Primary Outcome Measures :
  1. Local control of treated lesions [ Time Frame: 12 months ]
    Evaluation of proportion of patients free from progression from starting radiotherapy


Secondary Outcome Measures :
  1. Overall survival of treated patients [ Time Frame: 4 years ]
    Evaluation of proportion of patients alive

  2. Disease free survival of treated patients [ Time Frame: 4 years ]
    Evaluation of proportion of patients alive and free from progression



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients affected by soft-tissue sarcomas with lung metastases unsuitable for surgery
Criteria

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

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): NCT02561559


Contacts
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Contact: Marta Scorsetti, MD +39028224 ext 8524 marta.scorsetti@cancercenter.humanitas.it
Contact: Pierina Navarria, MD +39028224 ext 7458 piera.scorsetti@cancercenter.humanitas.it

Locations
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Italy
Istituto Clinico Humanitas Recruiting
Rozzano, MI, Milan, Italy, 20089
Contact: Pierina Navarria, MD    +39028224 ext 7458    pierina.navarria@cancercenter.humanitas.it   
Sponsors and Collaborators
Istituto Clinico Humanitas
Investigators
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Principal Investigator: Marta Scorsetti, MD Istituto Clinico Humanitas

Publications:
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Responsible Party: Michele Tedeschi, MD, Istituto Clinico Humanitas
ClinicalTrials.gov Identifier: NCT02561559     History of Changes
Other Study ID Numbers: 1393
First Posted: September 28, 2015    Key Record Dates
Last Update Posted: October 24, 2018
Last Verified: October 2018

Additional relevant MeSH terms:
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Neoplasm Metastasis
Sarcoma
Neoplasms
Soft Tissue Neoplasms
Neoplastic Processes
Pathologic Processes
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms by Site