Does Neo Adjuvant Radiotherapy improve breast cancer outcomes? An Open label, randomised, parallel group, superiority trial to compare the disease free survival following NEO-adjuvant versus adjuvant HYPO-fractionated RadioTherapy in breast cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,121
- 试验地点
- 1
- 主要终点
- Any Breast cancer recurrence, local/regional/distant, development of ipsilateral or contralateral invasive breast cancer, ductal carcinoma in situ or any invasive second malignancy or death
研究概览
简要总结
Neoadjuvant systemic therapy is commonly used to downstage breast cancers prior to surgical curative resection. This is conventionally followed by adjuvant radiation therapy (ART) to improve local control as well as distant metastatic spread. There is credible data suggesting that a change in sequencing of radiation therapy from ART to neoadjuvant radiotherapy (NART) is likely to improve disease control. Studies support the concept of enhanced immune modulation following radiation therapy thereby improving local response to breast cancer and also reducing the risk of systemic disease progression. Modern literature has confirmed durable responses of breast cancers to local ultra hypofractionated radiotherapy.
In our study, patients eligible to receive neoadjuvant systemic chemotherapy with a curable intent, will be consented. Following neo adjuvant chemotherapy, patients will be randomised between receiving pNART and ART. The primary objective of the study will be to investigate if NART improves breast cancer disease free survival compared to ART. Other secondary objectives will report locoregional control, overall survival, quality of life and safety of interventions in the treatment groups
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 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Age ≥ 18 years
- •Patients must have a pathological proof of an invasive epithelial breast malignancy at the treating institute. A core biopsy with adequate specimen quality is necessary for this. FNAC alone is not sufficient. Biopsies taken outside must have been reviewed for pathological confirmation and specimen adequacy at the treating institute.Patients with ductal and lobular cancers are eligible for the study.
- •Receptor status (Oestrogen receptor, Progesterone receptor and HER2 neu receptor) status should be documented. Patients can be enrolled with an equivocal HER2neu receptor report but in all such cases a confirmatory in-situ hybridisation should be done to confirm the status prior to initiation of taxane based chemotherapy.
- •ECOG performance status
- •Clinical stage I.
- •III disease as documented with adequate pretreatment staging. Adequate staging include either of the two following options: a. Whole body 18-FDG PET CT (preferred) b. Contrast enhanced CT scan of the thorax and abdomen and a bone scan. Note that chest X ray or USG abdomen are not acceptable substitutes.
- •Patients should have been planned for neoadjuvant chemotherapy as per institutional protocol.
- •Patients with tumour that is likely to be amenable for curative intent resection of the breast primary, following neoadjuvant therapy.
- •If the patient had nodal disease in the supraclavicular fossa (proven pathologically) or internal mammary nodes (proven radiologically or pathologically), then residual gross nodes should not be present in these regions post NACT.
排除标准
- •Patients planned for therapeutic mammoplasty.
- •Patients planned for chest wall perforator flaps.
- •This criteria will be re-evaluated after the data from the perforator substudy is available and has been reviewed by the DSMC.
- •Patients with non-epithelial malignant conditions of breast viz.
- •Sarcomas, lymphomas and phyllodes breast tumours.
- •Patients with skin cancer affecting the breast.
- •Prior radiotherapy to the ipsilateral breast or chest wall or mediastinum.
- •Concurrent illness, including severe infection that may jeopardise the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety
- •Serious medical or psychiatric conditions that might limit the ability of the patient to comply with the protocol.
- •Patients enrolled for trials of investigational drugs should not be enrolled for this study.
结局指标
主要结局
Any Breast cancer recurrence, local/regional/distant, development of ipsilateral or contralateral invasive breast cancer, ductal carcinoma in situ or any invasive second malignancy or death
时间窗: At 7 Years
次要结局
- Patient reported breast / chest wall induration(At 3 years)
- Additional cancer outcomes: Overall survival, Locoregional recurrence free survival, Distant metastasis free survival Patient reported outcomes(Clinician reported toxicity)
研究者
Dr Sanjoy Chatterjee
Tata Medical Centre, Kolkata