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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02581670
Recruitment Status : Recruiting
First Posted : October 21, 2015
Last Update Posted : December 20, 2019
Sponsor:
Information provided by (Responsible Party):
Michele Tedeschi, Istituto Clinico Humanitas

Tracking Information
First Submitted Date  ICMJE October 15, 2015
First Posted Date  ICMJE October 21, 2015
Last Update Posted Date December 20, 2019
Actual Study Start Date  ICMJE November 4, 2015
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 20, 2015)
  • Toxicity in oligometastatic breast cancer patients monitoring using CTCAE v.4 [ Time Frame: 3 years ]
  • Local control of disease after SBRT according to EORTC questionnaire [ Time Frame: 2 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 20, 2015)
  • Progression free survival using Kaplan-Meyer statistical curves [ Time Frame: 2 months ]
  • Overall survival using Kaplan-Meyer statistical curves [ Time Frame: 2 months ]
  • Quality of life at the end of the treatment with questionnaire EORTC QLQ C30 [ Time Frame: 2 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study on SBRT for Inoperable Lung and Liver Oligometastases From Breast Cancer
Official Title  ICMJE Prospective Non-randomized Phase II Study on Stereotactic Body Radiation Therapy for Medically Inoperable Lung and Liver Oligometastases From Breast Cancer
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Breast Cancer
  • Metastasis to Liver
  • Metastasis to Lung
Intervention  ICMJE Radiation: stereotactic radiation therapy (SRT)
Lung and liver stereotactic radiation therapy (SRT) in oligometastatic breast cancer patients unsuitable for surgery, using VMAT RapidArc approach
Study Arms  ICMJE Experimental: Oligometastatic breast cancer patients
Lung and liver stereotactic radiation therapy (SRT) in oligometastatic breast cancer patients medically inoperable, using VMAT RapidArc approach.
Intervention: Radiation: stereotactic radiation therapy (SRT)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 18, 2019)
58
Original Estimated Enrollment  ICMJE
 (submitted: October 20, 2015)
40
Estimated Study Completion Date  ICMJE July 2022
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Fiorenza De Rose, MD +390282247307 fiorenza.de_rose@cancercenter.humanitas.it
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02581670
Other Study ID Numbers  ICMJE 1437
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Michele Tedeschi, Istituto Clinico Humanitas
Study Sponsor  ICMJE Istituto Clinico Humanitas
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Fiorenza De Rose, MD Istituto Clinico Humanitas
Principal Investigator: Tiziana Comito, MD Istituto Clinico Humanitas
PRS Account Istituto Clinico Humanitas
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP