CTRI/2024/07/070327尚未招募Unknown
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 - NEO-HYPORT
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Age = 18 years
- •2. 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.
- •3. 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.
- •4. ECOG performance status 0 - 2.
- •5. 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.
- •6. Patients should have been planned for neoadjuvant chemotherapy as per institutional
- •7. Patients with tumour that is likely to be amenable for curative intent resection of the
- •breast primary, following neoadjuvant therapy.
- •8. 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
- •1. Patients planned for therapeutic mammoplasty.
- •2. 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
- •3. Patients with non-epithelial malignant conditions of breast viz. Sarcomas, lymphomas
- •and phyllodes breast tumours.
- •4. Patients with skin cancer affecting the breast.
- •5. Prior radiotherapy to the ipsilateral breast or chest wall or mediastinum.
- •6. Concurrent illness, including severe infection that may jeopardise the ability of the
- •patient to undergo the procedures outlined in this protocol with reasonable safety
- •7. 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.
研究者
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