Postmastectomy Hypofractionated Versus Conventional Fractionated Radiotherapy in High Risk Breast Cancer: a Phase III Randomized Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Fudan University
- Enrollment
- 1494
- Locations
- 3
- Primary Endpoint
- Loco-regional recurrence (LRR)
- Status
- Recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
The study was designed to investigate whether hypofractionated adjuvant radiotherapy is noninferior to conventionally fractionated adjuvant radiotherapy in terms of efficacy and toxicities for high risk breast cancer patients treated with mastectomy
Detailed Description
The randomization is between 50 Gy / 25 fractions and 42.5 Gy/16 fractions, 5 fractions weekly. Eligible breast cancer patients with mastectomy and axillary dissection will be randomized 1:1 into two groups: conventional fractionated (CF) radiotherapy of 50 Gy / 25 fractions and hypofractionated (HF) radiotherapy of 42.5 Gy/16 fractions, 5 fractions weekly. The primary endpoint is loco-regional recurrence. Other cancer related events and acute/late radiation morbidities will also be evaluated. The patients will be followed for 10 years. It is hypothesized that for women operated for high risk breast cancer with indication of postmastectomy adjuvant radiotherapy, hypofractionated radiotherapy is noninferior to conventional fractionated radiotherapy in terms of the efficacy and toxicities.
Investigators
Jinli Ma
Associate Professor of department of radiation oncology
Fudan University
Eligibility Criteria
Inclusion Criteria
- •Age18-75 years
- •Pathologically confirmed invasive breast cancer
- •Treated with mastectomy and axillary lymph node dissection with more than 10 resected lymph nodes. Immediate or delayed ipsilateral breast cancer reconstruction is accepted
- •Negative surgical margins
- •Pathologic T1-2N1 with at least one of the following risk factors: \<40 years, Grade 3, lymphovascular invasion positive, ER/PR negative or HER2 overexpression, or pT3-4, or pN2-3 (four or more positive axillary lymph nodes)
- •No distant metastases
- •No supraclavicular or internal mammary nodes metastases
- •Adjuvant systemic therapy with chemotherapy, endocrine therapy and anti-HER2 treatment is accepted.
- •No neoadjuvant chemotherapy
- •Fit for postoperative radiotherapy. No contraindications to radiotherapy
Exclusion Criteria
- •Concurrent or previous malignancy excluding basal or squamous cell carcinoma of the skin
- •Previous radiotherapy to the chest wall or regional lymph node areas
- •Patients with severe non-malignant comorbidity in cardiovascular or respiration system
- •Patients with medical contraindication for radiotherapy: systemic lupus erythematosus, cirrhosis
- •pT1-2N1 with none of the following risk factors: \<40 years, Grade 3, lymphovascular invasion positive, ER/PR negative or HER2 overexpression
- •Patients with supraclavicular or internal mammary nodes metastases
- •Known definitive clinical or radiologic evidence of metastatic disease
- •Bilateral breast cancer or historically confirmed contralateral invasive breast cancer
- •Treated with neoadjuvant chemotherapy
- •ECOG: 3-4
Outcomes
Primary Outcomes
Loco-regional recurrence (LRR)
Time Frame: every 3 months during the first 2 years after the last fraction received, every 6 months during 3-5 years, every year during 6-10 years
Defined as any clinical and biopsy-proven tumor recurrence involving the ipsilateral chest wall and/or regional nodes (including axillary, supraclavicular, infraclavicular, or internal mammary nodes). Time to loco-regional recurrence is defined as the interval starting from the date of randomization until the event. LRR will be assessed every 3 months during the first 2 years after the last fraction received, every 6 months during the following 3-5 years and every year thereafter through 10 years
Secondary Outcomes
- Distant metastasis free survival (DMFS)(every 3 months during the first 2 years after the last fraction received, every 6 months during 3-5 years, every year during 6-10 years)
- Disease free survival (DFS)(every 3 months during the first 2 years after the last fraction received, every 6 months during 3-5 years, every year during 6-10 years)
- Overall survival (OS)(every 3 months during the first 2 years after the last fraction received, every 6 months during 3-5 years, every year during 6-10 years)
- CTCAE Toxicity Assessment-Acute toxicity(before treatment, every week of treatment, the end of treatment, 2 weeks, 3 months after the last fraction received, every year through 10 years)
- CTCAE Toxicity Assessment-Late toxicity(before treatment, every year after the last fraction received through 10 years)
- LENT-SOMA Toxicity Assessment(before treatment, every year after the last fraction received through 10 years)
- Number of patients with Arm Lymphedema(before treatment, every year after the last fraction received through 10 years)
- Number of patients with impaired shoulder movement (Range of motion of the shoulders)(before treatment, every year after the last fraction received through 10 years)
- Number of patients with symptomatic rib fracture(before treatment, every year after the last fraction received through 10 years)
- Number of patients with brachial plexopathy(before treatment, every year after the last fraction received through 10 years)
- Number of patients with reconstruction complications(before treatment, every year after the last fraction received through 10 years)
- Quality of Life-EORTC breast-cancer module (BR23)(before treatment, the end of treatment, every year after the last fraction received through 10 years)
- Cosmetic outcomes for patients received mastectomy with reconstruction(before treatment, every year after the last fraction received through 10 years)
- Quality of Life Life-EORTC QLQ-C30 (version 3)(before treatment, the end of treatment, every year after the last fraction received through 10 years)