A Randomised Phase Ii Study Of Pre-Operative Or Peri-Operative Docetaxel, Oxaliplatin, Capecitabine (Dox) Regimen In Patients With Locally Advanced Resectable Gastric Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 29
- 主要终点
- the difference in percentage of patients receiving all the planned chemotherapeutic cycles between the two arms.
研究概览
简要总结
Study design:
Multicenter, randomized, open label phase II study Arm A: DOX 4 cycles - Surgery - Follow-up Arm B: DOX 2 cycles - Surgery - DOX 2 cycles - Follow-up
Population:
Male or female, 18-75 years of age, with a diagnosis of histologically confirmed, potentially resectable adenocarcinoma of the stomach.
Sample Size: Planned sample size is 90 patients, 45 patients for each arm (p0=50%, p1=80%, alpha=0.05 (two sides), beta=0.2)
Treatment Plan:
Treatment will be administered for 4 and 2 cycles before surgery in arm A and B, respectively, and in arm B for a further 2 cycles after surgery unless progression or unacceptable toxicity occurs, or a patient refuses treatment. In such cases patients will go off treatment. 3-6 weeks after the end of the fourth (arm A) or second (arm B) preoperative cycle, patients will undergo surgery.
After surgery 3-6 weeks from surgery patients in arm B will receive 2 more cycles.
DOX: Docetaxel 35 mg/m2 day 1 and 8 Oxaliplatin 80 mg/m2 day 1 Capecitabine 750 mg/m2 x 2 daily for 2 weeks
Cycles repeated every 3 weeks
Evaluation criteria: Tumor assessment will be performed according to the RECIST criteria (version 1.1).
Duration of Study:
Overall study duration: 07/2010- 03/2017 Planned study duration per patient: 5 years
详细描述
Title: A randomised phase II study of pre-operative or peri-operative docetaxel, oxaliplatin, capecitabine (DOX) regimen in patients with locally advanced resectable gastric cancer.
Clinical Phase: II
Study Objectives:
Primary:
The percentage of patients receiving all the planned chemotherapeutic cycles.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed written informed consents
- •Male or female 18-75 years of age
- •Diagnosis of histologically confirmed, potentially resectable adenocarcinoma of the stomach
- •cT3 subserosal - cT4a - cT4b (7th edition UICC TNM) or bulky lymph node metastases independently of T
- •ECOG performance status of 0-1 at study entry
- •Laboratory requirements (≤ 7 days prior chemotherapy start):
- •Hematology:
- •I) Neutrophils > 1.5 x 109 /L II) Platelets > 100 x 109 /L III) Hemoglobin > 10g/dL
- •Hepatic function I) Total bilirubin < 1.25 UNL II) AST (SGOT) and ALT (SGPT) < 2.5xUNL III) Alkaline phosphatase < 2.5xUNL
- •Renal function I) Creatinine <1.5 UNL In the event of border-line values, the calculated creatinine clearance should be > 60 mL/min;
- •Written informed consent signed and dated before randomization procedures, including expected cooperation of patients for treatment and follow-up, must be obtained and documented according to local regulatory requirements.
- •Effective contraception for both male and female patients if the risk of conception exists
排除标准
- •Early gastric cancer (if N0)
- •T2 (according to 7th edition of UICC TNM) if N0
- •Linitis plastica
- •Positive peritoneal cytology
- •Distant metastases
- •Neoplasm involving the gastro-esophageal junction
- •Pertoneal involvement
- •Concurrent chronic systemic immune therapy
- •Any investigational agent(s) administered 4 weeks prior to entry
- •Clinically relevant coronary artery disease, a history of myocardial infarction or of hypertension not controlled by therapy within the last 12 months
- •Known grade 3 or 4 allergic reaction to any of the components of the treatment
- •Known drug abuse/alcohol abuse
- •Legal incapacity or limited legal capacity
- •Medical or psychological condition which, in the opinion of the investigator, would not permit the patient to complete the study or sign meaningful informed consent
- •Women who are pregnant or breastfeeding
- •Acute or subacute intestinal occlusion
- •Any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ of the cervix. (Patients with a previous malignancy but without evidence of disease for ≥ 5 years will be allowed to enter the trial)
研究组 & 干预措施
Arm A
DOX 4 cycles - Surgery - Follow-up
DOX:
Docetaxel 35 mg/m2 day 1 and 8 by one hour infusion; Oxaliplatin 80 mg/m2 day 1 by two hours infusion; Capecitabine 750 mg/m2 x 2 daily for 2 weeks, per OS.
Treatment should be administered for 4 cycles before surgery. Each cycle will be repeated every 3 weeks.
干预措施: DOX 4 cycles - Surgery (Other)
Arm B
DOX 2 cycles - Surgery - DOX 2 cycles - Follow-up
DOX:
Docetaxel 35 mg/m2 day 1 and 8 by one hour infusion; Oxaliplatin 80 mg/m2 day 1 by two hours infusion; Capecitabine 750 mg/m2 x 2 daily for 2 weeks, per OS.
Treatment should be administered for 2 cycles before surgery and for further 2 cycles after surgery, unless progression of disease or unacceptable toxicity occurs, or patient refusal. In these cases patients will go off treatment.
Each cycle will be repeated every 3 weeks.
干预措施: DOX 2 cycles - Surgery - DOX 2 cycles (Other)
结局指标
主要结局
the difference in percentage of patients receiving all the planned chemotherapeutic cycles between the two arms.
时间窗: 7 years
次要结局
- The percentage of tumors downstaged at the diagnosis(7 years)
- Treatment tolerability and safety and tumor response in patients with pathological stage pT1-3 vs pT0(7 years)
- Efficacy comparation between curative vs palliative surgery(7 years)
- Diagnostic capability of PET(7 years)
- Diagnostic capability of CT scan, CT/PET and laparoscopy(7 years)
- Biological profile of treatment toxicity(7 years)
- Biologcal profile of treatment response(7 years)
- Number of patients with adverse events of grade 3-4 as a measure of safety and tolerability(7 years)
- Time to progression(7 years)
- Overall survival(7 years)
- Biological profile of treatment prognosis(7 years)