Overview

Radiotherapy for Extracranial Oligometastatic Breast Cancer

Status:
Not yet recruiting
Trial end date:
2023-09-30
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Chinese Academy of Medical Sciences
Collaborators:
China-Japan Union Hospital, Jilin University
Liaoning Tumor Hospital & Institute
Peking Union Medical College Hospital
Shanxi Province Cancer Hospital
Taizhou Hospital of Zhejiang Province
West China Hospital
Wuhan University
Criteria
Inclusion Criteria:

- 18-70 years old

- ECOG performance status 0-2.

- Metachronous extracranial oligometastatic diseases which occurred after 3 months after
radical surgery, and diagnosed by pathology or imaging. Biopsy of metastasis is
preferred.

- Total number of metastases 1-5 , the maximum diameter of metastases ≤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 simultaneous locoregional recurrences.

- 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