Radiotherapy for Extracranial Oligometastatic Breast Cancer

NCT ID: NCT04646564

Last Updated: 2022-01-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 170 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-06
• Study Completion Date: 2026-04-30

Brief Summary

More and more evidence suggests that local radiotherapy can improve the outcomes for patients with oligometastatic disease. The purpose of this study is to assess the impact of radiotherapy, compared with standard systemic therapy alone, on survival, local control and toxicities in patients with extracranial oligometastatic breast cancer. Eligible patients are randomized in a 1:2 ratio between the control arm (standard systemic therapy), and the WLRT arm (standard systemic therapy + radiotherapy). Randomization will be stratified by three factors: visceral metastasis (yes vs.no), number of metastases(≤2 vs. >2), hormone receptor(positive vs. negative). SBRT technique is preferred. During and after radiotherapy, the patients are followed and the efficacy and toxicities of radiotherapy are evaluated.

Conditions

Breast Cancer Metastatic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

control arm

standard of care

Group Type: ACTIVE_COMPARATOR

standard of care

Intervention Type: DRUG

patients receive appropriate therapy at the discretion of the treating oncologist, i.e. systemic therapy according to molecular subtypes, including chemotherapy, endocrine therapy, targeted therapy, or immunotherapy.

study arm

radiotherapy + standard of care

Group Type: EXPERIMENTAL

standard of care

Intervention Type: DRUG

patients receive appropriate therapy at the discretion of the treating oncologist, i.e. systemic therapy according to molecular subtypes, including chemotherapy, endocrine therapy, targeted therapy, or immunotherapy.

radiotherapy + standard of care

Intervention Type: RADIATION

Patients receive radiotherapy to all known metastases. SBRT technique is preferred, especially for metastases in bone, lung and liver. Conventional RT can be used when SBRT is not appropriate, such as metastasis in mediastinal or contralateral supraclavicular nodal regions. Total doses of 30Gy to 50Gy in 5 fractions for SBRT are recommended depending on the tolerance of adjacent normal tissue. Total dose of 60Gy in 25 fractions is recommended for conventional RT.

Patients can receive systemic therapy concurrently with RT at the discretion of treating radiation oncologist. After completion of SBRT to all sites of known metastatic disease, patients will continue standard of care therapy per the treating oncologist.

Interventions

standard of care

patients receive appropriate therapy at the discretion of the treating oncologist, i.e. systemic therapy according to molecular subtypes, including chemotherapy, endocrine therapy, targeted therapy, or immunotherapy.

Intervention Type: DRUG

radiotherapy + standard of care

Patients receive radiotherapy to all known metastases. SBRT technique is preferred, especially for metastases in bone, lung and liver. Conventional RT can be used when SBRT is not appropriate, such as metastasis in mediastinal or contralateral supraclavicular nodal regions. Total doses of 30Gy to 50Gy in 5 fractions for SBRT are recommended depending on the tolerance of adjacent normal tissue. Total dose of 60Gy in 25 fractions is recommended for conventional RT.

Patients can receive systemic therapy concurrently with RT at the discretion of treating radiation oncologist. After completion of SBRT to all sites of known metastatic disease, patients will continue standard of care therapy per the treating oncologist.

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• 18-70 years old
• ECOG performance status 0-2.
• Newly-diagnosed or metachronous extracranial oligometastatic diseases confirmed by pathology or imaging, with or without locoregional disease (biopsy of metastasis is preferred).
• Total number of locoregional and metastatic lesions of 1-5 , the maximum diameter of lesions ≤5 cm and at least one lesion could be evaluated by RECIST1.1.
• Have received or plan to receive systemic therapy.
• All lesions could be safely treated by radiotherapy.
• Life expectancy > 6 months.
• Have adequate organ function.

Exclusion Criteria

• Have metastases in the central nervous system.
• have indications for palliative radiotherapy to reduce symptoms, such as pain, bleeding, obstruction, and pending fractures caused by the tumor.
• Have moderate/severe liver dysfunction (Child Pugh B or C) from liver metastases, .
• Malignant pleural effusion
• Unable to tolerate radiotherapy due to serious comorbidity
• Have received prior radiotherapy for target area
• Pregnant or lactating women

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Liaoning Cancer Hospital & Institute

OTHER

Sponsor Role: collaborator

Wuhan University

OTHER

Sponsor Role: collaborator

China-Japan Union Hospital, Jilin University

OTHER

Sponsor Role: collaborator

Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University

OTHER

Sponsor Role: collaborator

West China Hospital

OTHER

Sponsor Role: collaborator

Shanxi Province Cancer Hospital

OTHER

Sponsor Role: collaborator

Peking Union Medical College Hospital

OTHER

Sponsor Role: collaborator

Chinese Academy of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Shu lian Wang

Clinical professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shu-lian Wang, M.D

Role: PRINCIPAL_INVESTIGATOR

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Locations

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Wei-Fang Yang

Taizhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Shu-lian Wang, M.D

Role: CONTACT

wangsl@cicams.ac.cn

8610-87788803

Facility Contacts

Shu-lian Wang, M.D

Role: primary

wangsl@cicams.ac.cn

8610-87788803

Wei-Fang Yang, M.D.

Role: primary

Other Identifiers

NCC2493

Identifier Type: -

Identifier Source: org_study_id