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Study on SBRT for Inoperable Lung and Liver Oligometastases From Breast Cancer

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ClinicalTrials.gov Identifier: NCT02581670
Recruitment Status : Recruiting
First Posted : October 21, 2015
Last Update Posted : October 24, 2018
Sponsor:
Information provided by (Responsible Party):
Michele Tedeschi, Istituto Clinico Humanitas

Brief Summary:
Investigators designed a phase II study to evaluate safety and efficacy of lung and liver stereotactic radiation therapy (SRT) in oligometastatic breast cancer patients unsuitable for surgery, using VMAT RapidArc approach.

Condition or disease Intervention/treatment Phase
Breast Cancer Metastasis to Liver Metastasis to Lung Radiation: stereotactic radiation therapy (SRT) Phase 2

Detailed Description:
Investigators designed a prospective phase II study to evaluate safety and efficacy of lung and liver stereotactic radiation therapy (SRT) scheduled for oligometastatic breast cancer patients unsuitable for surgery with age major than 18 years old and with adequate performance status (ECOG), using VMAT RapidArc approach. The potential advantage of this technique is the ability to deliver a more selective irradiation to tumour's target while reducing doses to normal tissue, optimizing the therapeutic window.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Non-randomized Phase II Study on Stereotactic Body Radiation Therapy for Medically Inoperable Lung and Liver Oligometastases From Breast Cancer
Actual Study Start Date : November 4, 2015
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Oligometastatic breast cancer patients
Lung and liver stereotactic radiation therapy (SRT) in oligometastatic breast cancer patients medically inoperable, using VMAT RapidArc approach.
Radiation: stereotactic radiation therapy (SRT)
Lung and liver stereotactic radiation therapy (SRT) in oligometastatic breast cancer patients unsuitable for surgery, using VMAT RapidArc approach




Primary Outcome Measures :
  1. Toxicity in oligometastatic breast cancer patients monitoring using CTCAE v.4 [ Time Frame: 3 years ]
  2. Local control of disease after SBRT according to EORTC questionnaire [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Progression free survival using Kaplan-Meyer statistical curves [ Time Frame: 2 months ]
  2. Overall survival using Kaplan-Meyer statistical curves [ Time Frame: 2 months ]
  3. Quality of life at the end of the treatment with questionnaire EORTC QLQ C30 [ Time Frame: 2 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients aged >18 years with ECOG 0-2
  • Diagnosis of Breast Cancer
  • DFI (Disease-free interval) > 1 year
  • No extrapulmonary and/or extrahepatic disease or other metastatic sites stable or responding after chemotherapy
  • No life threatening conditions
  • Lung and liver lesions < 5 (with maximum diameter < 5 cm)
  • Chemotherapy completed at least 3 weeks before treatment
  • Chemotherapy started at least 2 weeks after treatment allowed
  • Systemic therapies other than chemotherapy allowed (i.e hormonal therapies and/or immunotherapy)
  • Written informed consent

Exclusion Criteria:

  • ECOG > 2
  • Pregnant women
  • Patients with inability to consent

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): NCT02581670


Contacts
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Contact: Fiorenza De Rose, MD +390282247307 fiorenza.de_rose@cancercenter.humanitas.it

Locations
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Italy
Istituto Clinico Humanitas Recruiting
Rozzano, Milano, Italy, 20089
Contact: Fiorenza De Rose, MD    +390282247307    fiorenza.de_rose@cancercenter.humanitas.it   
Contact: Tiziana Comito, MD    +390282247244    tiziana.comito@cancercenter.humanitas.it   
Sponsors and Collaborators
Istituto Clinico Humanitas
Investigators
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Principal Investigator: Fiorenza De Rose, MD Istituto Clinico Humanitas
Principal Investigator: Tiziana Comito, MD Istituto Clinico Humanitas

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Responsible Party: Michele Tedeschi, MD, Istituto Clinico Humanitas
ClinicalTrials.gov Identifier: NCT02581670     History of Changes
Other Study ID Numbers: 1437
First Posted: October 21, 2015    Key Record Dates
Last Update Posted: October 24, 2018
Last Verified: October 2018
Keywords provided by Michele Tedeschi, Istituto Clinico Humanitas:
oligometastatic breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasm Metastasis
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes