CTRI/2024/06/068272尚未招募2 期
Comparison of Responses after two Total Neoadjuvant Treatment Protocols in Rectal Cancer: A prospective phase II Randomised Controlled Trial - RETAI
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- A
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. Older than 18 years of age and less than 70 years
- •2.Clinical stage II (T3c-T4, N0) or stage III (any T, N1-2) biopsy proven rectal adenocarcinoma staged with magnetic resonance imaging (MRI), a full colonoscopy, and computed tomography (CT) of the chest, abdomen, and pelvis.
- •3.Eastern Cooperative Oncology Group (ECOG) score 0-1
- •4.Fit for Capecitabine-Oxaliplatin(CAP-OX) or FOLFOX based chemotherapy
- •5. Tumors located up to 10 cm from anal verge
- •6. Blood parameters: a white blood cell count of 4·0 × 10 ? cells per L or higher, platelet count of 100 × 10 ? per L or higher, a clinically acceptable haemoglobin level, a creatinine level indicating renal clearance of 50 mL/min or higher, and bilirubin level below 2mg/dl.
排除标准
- •1.Evidence of distant metastasis
- •2. Recurrent disease
- •3. Prior history of pelvic irradiation
- •4.Pelvic Kidney
- •5. Collagen vascular disease
- •6.ECOG performance status 2-3
- •7. Deranged kidney function tests
- •8.Not fit for Cap-OX or FOLFOX based chemotherapy
研究者
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