Prospective Randomised Trial Of Extended Chemotherapy During The Wait Period” Following Pre-Operative Neoadjuvant Chemoradiotherapy For Rectal Cancer

Royal Adelaide Hospital0 个研究点目标入组 50 人开始时间: 2011年3月31日最近更新: 2020年1月13日

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•1.Histologically proven adenocarcinoma, distal rectum (defined as being less than 12 cms. from the anal verge on rigid sigmoidoscopy)
•2.Non-metastatic (M0) disease as evidenced by CT chest and abdomen
•3. Patients who following MDT discussion, are deemed to require long course preoperative chemoradiotherapy as appropriate neo-adjuvant therapy for their rectal cancer prior to surgical management (clinical stage T3/4 or any node positive disease). The nature of surgical management will be at the discretion of the surgeon responsible for their care.
•4.WHO/ECOG Performance status <= 2
•5.Adequate bone marrow, hepatic, and renal fuction Haemoglobin greater than or equal to10.0 g/dL (transfusions allowed to achieve or maintain levels) absolute neutrophil count greater than or equal to 1.5 x 10 9/L
•platelet count greater than or equal to 100 x 10 9/L
•ALAT greater than or equal to10 2.5 x ULN
•ASAT greater than or equal to10 2.5 x ULN
•Alkaline phosphatase greater than or equal to10 2.5 x ULN
•Total bilirubin greater than or equal to10 1.5 x ULN
•Creatinine clearance > 50 mL/min (calculated according to Cockroft and Gault)
•6.Presence of adequate contraception in fertile patients

•Age – less than 18 or greater than 80 years
•2. Inability to provide informed consent
•3. Significant co-morbidities precluding the use of preoperative chemoradiotherapy, including the presence of clinically significant (i.e. active) cardiac disease
•4. Known dihydropyrimidine dehydrogenase deficiency
•5. Pregnant or breast feeding women

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