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

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

stereotactic radiation therapy (SRT)

Fiorenza De Rose, MD

Tiziana Comito, MD

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.

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 on SBRT for Inoperable Lung and Liver Oligometastases From Breast Cancer

Prospective Non-randomized Phase II Study on Stereotactic Body Radiation Therapy for Medically Inoperable Lung and Liver Oligometastases From Breast Cancer

Istituto Clinico Humanitas

Carcinoma

Disease Progression

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Participants with oligometastatic breast cancer with isolated progression after sustained (\>=6 month) response to systemic therapy. Participants will receive image guided, SBRT to the progressive lesion identified on imaging. Participants will be maintained on their existing line of systemic therapy. Systemic therapy will be held during days of radiation and resume following completion of radiation.

SBRT will be initiated as soon as possible, at not beyond 8 weeks of baseline measurements. Recommended dosing is per department standards for oligometastatic disease (ie, 10 Gy x 3 or 7-8 Gy x 5 fractions daily, excluding weekends and departmental holidays)

Stereotactic body radiotherapy

Amy Xu, MD, PhD

Atif Khan, MD

Alyson McIntosh, MD

The purpose of this study is to see if using Stereotactic Body Radiation Therapy/SBRT to treat a single metastatic site where cancer has worsened may be an effective treatment for people with oligometastatic breast cancer. Participants will stay on their usual drug therapy while they receive SBRT. This combination of SBRT to a single metastatic site and usual drug therapy may prevent participants' cancer from worsening in other metastatic sites or spreading.

A Study on Adding Precisely Targeted Radiation Therapy (Stereotactic Body Radiation Therapy) to the Usual Treatment Approach (Drug Therapy) in People With Breast Cancer

Stereotactic Body Radiation Therapy (SBRT) to Extend the Benefit of Systemic Therapy in Patients With Solitary Disease Progression

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

The primary objective is to assess progression free survival, defined as systemic progression or death, within 3 months from start of Stereotactic Body Radiation Therapy/SBRT delivery.

Memorial Sloan Kettering Cancer Center

Standard of care, i. e. no local radiotherapy in addition to standard systemic therapy (exception: palliative local treatment of symptomatic lesions where indicated)

Standard of care (standard systemic therapy) + study intervention

Ablative radiotherapy (radiosurgery, stereotactic radiotherapy, hypofractionated image-guided radiotherapy (IGRT)) with few high-dose fractions

Metastases-directed Radiotherapy

Kathrin Dellas, Professor

Elena Sperk, MD

Monika Panzer, MD

Michaela Riepl, MD

Reinhard E. Wurm, MD

Hilke Vorwerk, Prof.

Stefan Janssen, MD

Susann Popella, MD

Marcel Ott, MD

Eckhard Horst, MD

Rodrigo Hepp, MD

Sevda Toperim

Andreas Schreiber, MD

Jörg Zimmer, MD

Alexander Boicev, MD

Juergen Dunst, Prof.

Kathrin Dellas, Prof.

Evelyn Weinstrauch, MD

Sachsen-Anhalt

Jürgen Dunst, Professor

The prognosis for patients with metastatic breast cancer has improved continuously. Systemic therapies alone are not able to cure the disease permanently.

Investigators initiated this randomized controlled multinational and multicenter clinical trial to analyse the impact of a local metastases-directed radiotherapy in addition to standard systemic therapy in patients with oligometastatic breast cancer on progression-free survival and quality of life.

Preferably ablative radiotherapy (radiosurgery, stereotactic radiotherapy, hypofractionated image-guided radiotherapy (IGRT)) with few high-dose fractions. Larger lesions or lesions with critical normal tissue involvement should be treated with three-dimensional conformal radiation therapy (3D-CRT) or intensity-modulated radiation therapy (IMRT) in moderate hypofractionated radiotherapy (depending on the size and location of the target volume and the decision of the radiooncologist). For critical organs in the target volume, standard fractionated radiotherapy can be used.

Patients with oligometastatic breast cancer

Metastases-directed Radiotherapy in Addition to Standard Systemic Therapy in Patients With Oligometastatic Breast Cancer

Effectiveness and Tolerability of Metastases-directed Radiotherapy in Addition to Standard Systemic Therapy in Patients With Oligometastatic Breast Cancer: A Randomized Controlled Multinational and Multicenter Clinical Trial

Co-primary progression-free survival (PFS) according to Response Evaluation Criteria In Solid Tumors (RECIST)

Co-primary quality of life according to European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Cancer patients with 30 items (QLQ-C30) sum score

Proportion of participants treated per protocol

Proportion of participants with degree of toxicities as defined by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) and by Radiation Treatment Oncology Group (RTOG) by point in time of follow-up with higher degree indicating higher intensity

Research and Treatment of Cancer (EORTC) Quality of Life Questionaire for Cancer patients with 30 items (QLQ-C30) with different scales

Research and Treatment of Cancer (EORTC) Quality of Life Questionaire for breast cancer patients with 23 items (QLQ-BR23) on 4-point Likert scales with different directions

Research and Treatment of Cancer (EORTC) Patient satisfaction questionnaire for cancer patients with 33 items (PATSAT-C33) on 5-point Likert scale with higher scores indicating greater satisfaction

Number of patients with adverse and serious adverse events

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study on SBRT for Inoperable Lung and Liver Oligometastases From Breast Cancer	NCT02581670	Breast Cancer Metastasis to L... Metastasis to L...	stereotactic ra...	18 Years -	Istituto Clinico Humanitas
A Study on Adding Precisely Targeted Radiation Therapy (Stereotactic Body Radiation Therapy) to the Usual Treatment Approach (Drug Therapy) in People With Breast Cancer	NCT05534438	Oligometastatic... Breast Cancer Metastatic Brea... Metastatic Brea... ER+ Breast Canc... HER2+ Breast Ca...	Stereotactic bo...	18 Years -	Memorial Sloan Kettering Cancer Center
Metastases-directed Radiotherapy in Addition to Standard Systemic Therapy in Patients With Oligometastatic Breast Cancer	NCT04495309	Metastatic Brea...	Metastases-dire...	18 Years -	University Hospital Schleswig-Holstein
A Study on Adding Precisely Targeted Radiation Therapy (Stereotactic Body Radiation Therapy) to the Usual Treatment Approach (Drug Therapy) in People With Breast Cancer	NCT05534438	Oligometastatic... Breast Cancer Metastatic Brea... Metastatic Brea... ER+ Breast Canc... HER2+ Breast Ca...	Stereotactic bo...	18 Years -	Memorial Sloan Kettering Cancer Center
Study on SBRT for Inoperable Lung and Liver Oligometastases From Breast Cancer	NCT02581670	Breast Cancer Metastasis to L... Metastasis to L...	stereotactic ra...	18 Years -	Istituto Clinico Humanitas
A Study on Adding Precisely Targeted Radiation Therapy (Stereotactic Body Radiation Therapy) to the Usual Treatment Approach (Drug Therapy) in People With Breast Cancer	NCT05534438	Oligometastatic... Breast Cancer Metastatic Brea... Metastatic Brea... ER+ Breast Canc... HER2+ Breast Ca...	Stereotactic bo...	18 Years -	Memorial Sloan Kettering Cancer Center

Spots Global Cancer Trial Database for oligometastatic breast cancer