EUCTR2006-006532-21-FR进行中（未招募）1 期
Preoperative chemoradiotherapy and postoperative chemotherapy with capecitabine and oxaliplatin vs. capecitabine alone in locally advanced rectal cancer (PETACC-6) - PETACC-6
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- EORTC
- 入组人数
- 1,090
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Male or female patients with histologically proven adenocarcinoma of the rectum (tumour = 12
- •cm from the anal verge as assessed by rigid proctoscopy).
- •¨ Clinical tumour stage T3/4 or any node-positive disease (clinical stage according the TNM
- •classification system (Appendix J), positive nodes as diagnosed on endorectal ultrasound and/or
- •MRI). Tumour is staged by preferably a high resolution MRI. If MRI is not available,
- •locoregional staging must be performed by computed tomography plus endorectal ultrasound.
- •¨ No evidence of metastatic disease (as evidenced by negative CT-scan of the chest and
- •¨ The disease must be considered either resectable at the time of entry or expected to become
- •resectable after preoperative chemoradiation.
- •¨ Age = 18 years.
- •¨ WHO/ECOG Performance Status = 2
- •¨ No prior cytotoxic chemotherapy or radiotherapy for rectal cancer.
- •¨ No prior radiotherapy to the pelvis, for any reason.
- •¨ Presence of adequate contraception in fertile patients. Adequate methods of contraception are:
- •intra-uterine device, hormonal contraception, condom use with spermicide. Pregnant or
- •breastfeeding women are excluded from participation.
- •¨ Adequate bone marrow, hepatic and renal function:
- •¨ Haemoglobin = 10.0 g/dL (transfusions allowed to achieve or maintain levels), absolute
- •neutrophil count = 1.5 x 109/L, platelet count = 100 x 109/L,
- •¨ ALAT, ASAT = 2.5 x ULN,
- •¨ Alkaline phosphatase = 2.5 x ULN,
- •¨ Total bilirubin = 1.5 x ULN,
- •¨ Creatinine clearance > 50 mL/min (calculated according to Cockroft and Gault) and
- •¨ Creatinine = 1.5 x ULN.
- •¨ Ability to swallow tablets.
- •¨ Patient must not have been treated with any investigational drug, agent nor procedure, (i.e. did
- •not participate in another trial within 4 weeks) before entry in this trial.
- •No previous (within the last 5 years) or concurrent malignancies, with the exception of
- •adequately treated cone-biopsied in situ carcinoma of the cervix or basal cell carcinoma of the
- •¨ No 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.
- •¨ No known allergy or any other adverse reaction to any of the study drugs or to any related
- •¨ No known dihydropyrimidine dehydrogenase deficiency.
- •¨ No known significant impairment of intestinal resorption (e.g. chronic diarrhoea, inflammatory
- •bowel disease).
- •¨ No 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.
- •¨ No peripheral neuropathy = grade 2 (according to CTCAE v3.0)
- •¨ No serious uncontrolled intercurrent infections or other serious uncontrolled concomitant
- •¨ No organ allograft requiring immunosuppressive therapy.
- •¨ No requirement for concurrent use of the antiviral agent sorivudine or chemically related
- •analogues, such as brivudine.
- •¨ No 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.
- •¨ No psychological, familial, sociological or geographical condition potentially hampering
- •compliance with the study protocol and follow-up schedule (these conditions should be
- •discussed with the patient before registration in the tr
排除标准
- •-severe renal impairment (creatinine clearance below 30 ml/min)
- •-pregnancy and lactation
- •-hypersensitivity to capecitabine or 5-FU or to any of the excipients
- •-patients with history of severe and unexpected reactions to fluoro pyrimidine therapy
- •-patients with known dihydropyrimidine dehydrogenase (DPD) deficiency
- •-patients with severe leucopenia, neutropenia and thrombocytopenia
- •-severe hepatic impairment
- •-concomittant use of sorivudine or its chemically related analogues such as brivudine
- •-patients with known allergy against oxaliplatin or other platinum compounds
- •-patients with impaired bone marrow function
- •-patients with pre-excisting peripheral neuropathy
研究者
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