NCT02581670

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
65

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started Nov 2015

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 15, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 21, 2015

Completed
14 days until next milestone

Study Start

First participant enrolled

November 4, 2015

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

May 4, 2022

Status Verified

May 1, 2022

Enrollment Period

7.9 years

First QC Date

October 15, 2015

Last Update Submit

May 3, 2022

Conditions

Breast CancerMetastasis to LiverMetastasis to Lung

Keywords

oligometastatic breast cancer

Outcome Measures

Primary Outcomes (2)

  • Toxicity in oligometastatic breast cancer patients monitoring using CTCAE v.4

    3 years

  • Local control of disease after SBRT according to EORTC questionnaire

    2 years

Secondary Outcomes (3)

  • Progression free survival using Kaplan-Meyer statistical curves

    2 months

  • Overall survival using Kaplan-Meyer statistical curves

    2 months

  • Quality of life at the end of the treatment with questionnaire EORTC QLQ C30

    2 months

Study Arms (1)

Oligometastatic breast cancer patients

EXPERIMENTAL

Lung and liver stereotactic radiation therapy (SRT) in oligometastatic breast cancer patients medically inoperable, using VMAT RapidArc approach.

Radiation: stereotactic radiation therapy (SRT)

Interventions

stereotactic radiation therapy (SRT)RADIATION

Lung and liver stereotactic radiation therapy (SRT) in oligometastatic breast cancer patients unsuitable for surgery, using VMAT RapidArc approach

Oligometastatic breast cancer patients

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Clinico Humanitas

Rozzano, Milano, 20089, Italy

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeuticsStereotaxic TechniquesNeurosurgical ProceduresSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Fiorenza De Rose, MD

    Istituto Clinico Humanitas

    PRINCIPAL INVESTIGATOR

  • Tiziana Comito, MD

    Istituto Clinico Humanitas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 15, 2015

First Posted

October 21, 2015

Study Start

November 4, 2015

Primary Completion

October 1, 2023

Study Completion

October 1, 2023

Last Updated

May 4, 2022

Record last verified: 2022-05

Locations

IT(1)