Phase II Clinical Trial ok weekly administration of oxaliplatin plus capecitabine and radioteraphy followed by surgery in patients with resectable locally advanced rectal cancer

Grupo de Tratamiento de los Tumores Digestivos0 个研究点开始时间: 2006年4月26日最近更新: 2012年4月18日

适应症

试验速览

暂无简介。

•1. Histologically confirmed rectal adenocarcinoma (< 15 cm from the anal verge)
•2. Surgical locally advanced disease (T3 or T4 tumors) with or without regional lymph node involvement.
•3. Radiologically measurable disease
•4. No previous antineoplastic treatment
•5. Age 18-75
•6. ECOG 0 to 1.
•7. No distant metastasis
•8. No tumoral bleeding requiring blood trasfusion of 2 concentrates/week
•9. Pre-treatment external derivation in occlusive tumors with important symptomatic disease
•10. Life expectancy over 12 weeks
•11. Adequate bone marrow function, determined by the following: Leucocytes >/ 4 x 109/l, Neutrophils >/ 1.5 x 109/l, Platelets >/ 100 x 109/l, Haemoglobin >/ 10 g/dl
•12. Adequate liver function, determined by the following:Bilirubine < 1.25 upper normal limit (UNL), AST, ALT y alkaline phosphatase /< 2.5 UNL.
•13. Adequate renal function, determined by the following: Serum creatinine /< 106 micromol/l or creatinine clearance over 50ml/min
•14. Adequate nutritional status: wheight loss < 10% and albumin level > 35 g/L
•15.- Written informed consent according to ICH-GCP
•Are the trial subjects under 18?
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•1. Non-resectable rectal cancer: Sacral bone involvement. Bilateral ureteral involvement
•2. Second neoplasy with the exception of adequately treated basal cell and spinocelular skin cancer, as well as cervical cancer.
•3. Pregnancy or breast feeding
•4. Absence of contraception
•5. Medical history of miocardial infraction in the previous 6 months
•6. Congestive heart disease or non-stable arrithmias despite of specific treatment.
•7. Contraindication to surgery
•8. Contraindication to oxaliplatin or capecitabine
•9. Psicological, familiar or geographical problems that can interfere with the optimal follow-up and/or adherence to treatment scheme.
•10. Syncronic colon neoplasia
•11. Peripherial previous neuropathy

发起方