Preoperative chemoradiotherapy and postoperative chemotherapy with capecitabine and oxaliplatin vs. capecitabine alone to establish disease-free survival outcomes in locally advanced rectal cancer (PETACC-6)

Australasian Gastro-Intestinal Trials Group (AGITG)0 个研究点目标入组 1,090 人开始时间: 2008年8月18日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•1.Male or female patients with histologically proven adenocarcinoma of the rectum (tumour = 12 cm from the anal verge as assessed by rigid proctoscopy)
•2.T3/4 or any node-positive disease
•3.No evidence of metastatic disease
•4.The disease must be considered either resectable at the time of entry or expected to become resectable after preoperative chemoradiation.
•5.Age = 18 years.
•6.World Health Organisation (WHO) / Eastern Cooperative Oncology Group (ECOG) Performance Status = 2
•7.No prior cytotoxic chemotherapy or radiotherapy for rectal cancer.
•8.No prior radiotherapy of the pelvis, for any reason.
•9.Presence of adequate contraception in fertile patients. Pregnant or breastfeeding women are excluded from participation.
•10.Adequate bone marrow, hepatic and renal function:
•11.Haemoglobin = 10.0 g/dL, absolute neutrophil count = 1.5 x 109/L, platelet count = 100 x 109/L,
•12. Alanine transaminase (ALAT)and aspartate transaminase (ASAT) = 2.5 x ULN
•13.Alkaline phosphatase = 2.5 x ULN
•14.Total bilirubin = 1.5 x ULN
•15.Creatinine clearance > 50 mL/min
•16.Creatinine = 1.5 x ULN
•17.Ability to swallow tablets
•18.Written informed consent

•1. Pregnant or breastfeeding women or fertile patients not using adequate contraception.
•2.Prior cytotoxic chemotherapy or radiotherapy for rectal cancer.
•3.Prior radiotherapy of the pelvis, for any reason.
•4. Previous (within the last 5 years) or concurrent malignancies.
•5.Clinically significant (i.e. active) cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmia not well controlled with medication) or myocardial infarction within the last 12 months.
•6.Significant impairment of intestinal resorption (e.g. chronic diarrhoea, inflammatory bowel disease).
•7.Pre-existing condition which would deter chemoradiotherapy or radiotherapy, i.e. fistulas, severe ulcerative colitis (particularly patients currently taking Sulphasalazine), Crohn’s disease, prior adhesions.
•8.Peripheral neuropathy = grade 2 (according to Common Terminology Criteria for Adverse Events (CTCAE) v3.0).
•9.History of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant precluding informed consent or interfering with compliance for oral drug intake.

发起方

Australasian Gastro-Intestinal Trials Group (AGITG)