Neoadjuvant Radiotherapy in breast Cancer, A study on the optimal sequencing of radiation in breast cancer.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 152
- 试验地点
- 1
- 主要终点
- Pathological complete response
研究概览
简要总结
With this trial we aim to study whether the addition of Neoadjuvant radiotherapy following neoadjuvant chemotherapy in breast cancer patients improves pathological complete response which translates into better long term outcomes in comparison to adjuvant radiotherapy.This will be a Randomise,parallel assigned, open label 2 arm trial with patients being randomised post Neoadjuvant chemotherapy to either receive Neoadjuvant Radiotherapy followed by Surgery or directly to Surgery followed by Adjuvant chemotherapy with the primary outcome being Pathological complete response.In view of many phase 2 studies done showing that the neoadjuvant RT is feasible and may be more beneficial, a clinical phase 3 study is desirable. A phase 3 RCT answering the question will clarify the proper sequencing of radiotherapy in patients of breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Eligibility for NACT: Patients with inoperable breast cancer: a)Bulky or matted cN2 axillary nodes b)cN3 nodal disease c)cT4 tumors(Inflammatory breast cancer if disease can be contained in radiotherapy portal) In select patients with operable breast cancer: a)HER2-positive disease and TNBC, if ≥cT2 or ≥cN1 b)Large primary tumor relative to breast size in a patient who desires breast conservation.
- •c)cN+ disease likely to become cN0 with preoperative systemic therapy.
- •d)cT1c, cN0, HER2-positive disease and TNBC.
- •Pathological evidence of breast cancer 3)Informed consent for NACT signed by the patient 4)Absence of Distant mets 5)Age ≥18 years at the time of randomisation 6)Performance status ≤ 2.
排除标准
- •Pregnancy or lactation 2)Prior radiotherapy of the affected or contralateral breast 3)Connective tissue disease, including rheumatoid arthritis and thromboangiitis obliterans 4)Cardiac comorbidities: symptomatic coronary heart disease, prior heart attack, heart failure NYHA II or AHA C, pacemaker, and/or implanted defibrillator 5)Other medical conditions that prohibit the neoadjuvant chemotherapy (i.e. psychiatric diseases, non-compliance, etc.) 6)Patients with pure ductal carcinomas in situ.
- •Patients with non-epithelial malignant conditions of the breast viz.
- •Sarcomas, lymphomas, phyllodes tumors 8)Synchronous primary.
结局指标
主要结局
Pathological complete response
时间窗: Post surgical resection(Post BCS or MRM) in both arms.
次要结局
- Local recurrence rate [in affected breast] (LR)(5 years)
- locoregional recurrence rate (LRR)(5 years)
- Disease free survival (DFS)(5 years)
- Disease metastases free survival (DMFS)(5 years)
- Overall survival (OS)(5 years)
- Disease specific survival (DSS)(5 years)
- Assessment of cosmetic results by the physicians(5 years)
- Measurement of the quality of life (QOL)(0,6 months and then yearly for 5 years)
- Assessment of arm lymphedema rates(0,6 months and then yearly for 5 years)
- Assessment of Brachial plexopathy(Baseline and then yearly for 5 years)
- Assessment of Acute radiation Toxicity(Pre RT and Post RT)
- R0 resection rate(Post Surgery)
- Sentinel Lymph node biopsy yield(Post SLNB)
- Health economics(Out of pocket expenditure)(Post completion of Radiotherapy)
- Surgeon questionnaire for ease of surgery(At time of discharge post Surgery)
- Decrease in Ki67 post Neoadjuvant therapy(Post Surgery)
- Residual Cancer Burden(Post Surgery)
- Assessment of Radiation Doses to critical structures and Organs at risk.(Post Radiotherapy)
研究者
Rishi P Nair
All India Institute of Medical Sciences,Jodhpur