jRCTs041230019招募中不适用
A Multicenter phase II study to investigate the efficacy of systemic chemotherapy in patients with peritoneal WAshing cytoLogy-positive potentially CUrable pancREatic cancer (WALCURE trial) (WALCURE trial)
未提供0 个研究点目标入组 208 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 208
- 主要终点
- Overall survival
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 20age old over 至 No limit（—）
- 性别
- All
入选标准
- •(i) Patients with histologically- or cytologically-confirmed adenocarcinoma or adenosquamous carcinoma of the pancreas
- •(ii) Patients with a diagnosis of primary resectable or borderline resectable (BR-PV and BR-A) pancreatic cancer at enrollment (General Rules for the Study of Pancreatic Cancer, the 7th edition) who tested positive for peritoneal washing cytology during staging laparoscopy or laparotomy before the start of treatment
- •(iii) Patients aged 20 years or older at enrollment
- •(iv)Patients with a PS of 0 to 1
- •(v)Patients who have not received prior treatment (such as radiotherapy, chemotherapy, and immunotherapy) for the underlying disease
- •(vi)Patients who have adequate major organ function
- •White blood cells: 12,000 /mm3 or less
- •Neutrophils: 1,500 /mm3 or more
- •Hemoglobin levels: 9.0 g/dL or more
- •Platelets: 100,000 /mm3 or more
- •Total bilirubin: less than 2.0 mg/dL (3.0 mg/dL or less in patients who underwent biliary drainage)
- •Creatinine: 1.5 mg/dL or less
- •AST and ALT: 2.5 multiplied by the upper limit of the institutional normal range
- •(vii) Patients who have received less than one month of prior chemotherapy and who have not had apparent tumor progression or serious adverse events since the start of treatment.
- •(viii) Patients who have provided consent to participate in this study
排除标准
- •(i) Patients who have received prior treatment (such as radiotherapy, chemotherapy, and immunotherapy) for the underlying disease (However, patients who have had less than one month of prior chemotherapy and who have not had apparent tumor progression or serious adverse events since the start of treatment are acceptable for enrolment.)
- •(ii) Patients with primary unresectable pancreatic lesions
- •(iii) Patients who underwent resection of the primary tumor
- •(iv) Patients with peritoneal metastatic nodules or those with metastatic lesions, such as lymph nodes, other than the liver, lung, bone, or regional lymph nodes
- •(v) Patients with contraindications or known history of severe hypersensitivity or infusion related reactions to gemcitabine, nab-paclitaxel/paclitaxel, liposomal irinotecan, leucovorin, or fluorouracil and to any of the excipients
- •(vi) Patients with known infection or inflammation at study enrollment (including those who have a fever of 38 degrees celsius or higher)
- •(vii) Patients with serious (hospitalization needed) complications (such as heart disease, intestinal paralysis, ileus, confirmed diagnosis of interstitial lung disease, difficult-to-control diabetes, renal failure, and hepatic cirrhosis)
- •(viii) Patients with excessive ascites or pleural effusion
- •(ix) Patients receiving atazanavir hydrochloride
- •(x) Patients with fresh gastrointestinal bleeding requiring repeated blood transfusions
- •(xi) Patients with diarrhea (4 times or more a day or watery stool)
- •(xii) Patients who are receiving antipsychotic treatment or have psychiatric disorder potentially requiring treatment and are unable to understand an explanation
- •(xiii) Patients with synchronous double cancer at enrollment
- •However, cancer with a 5-year relative survival of 95% or more is excluded from the exclusion criteria even if disease-free interval is less than 5 years.
- •To be specific, the following are excluded:
- •(In general, each staging should be based on UICC-TNM 7th edition or equivalent Japanese classification of cancers.)
- •a)Clinical stage I prostate cancer
- •b)Clinical stage 0 or I laryngeal cancer in which complete response was achieved by radiotherapy
- •c)Completely resected cancer with the following pathologic staging:
- •Gastric cancer (adenocarcinoma), Stages 0 to I; colorectal cancer (adenocarcinoma), Stages 0 to I;
- •esophageal cancer (squamous cell carcinoma, adenosquamous carcinoma, or basaloid cell carcinoma), Stage 0;
- •breast cancer (ductal carcinoma in situ or lobular carcinoma in situ), Stage 0;
- •breast cancer (infiltrating duct carcinoma, infiltrating lobular carcinoma, or Paget's disease), Stages 0 to IIA;
- •endometrial cancer (endometrioid adenocarcinoma or mucinous adenocarcinoma), Stage I; prostate cancer (adenocarcinoma), Stages I to II;
- •cervical cancer (adenosquamous carcinoma), Stage 0; thyroid cancer (papillary carcinoma or follicular carcinoma), Stages I to III;
- •kidney cancer (clear cell carcinoma or chromophobe cell carcinoma), Stage I;
- •other lesions equivalent to intramucosal carcinoma
- •(xiv) Pregnant women or nursing mothers and women of child-bearing potential (who wish to become pregnant)
- •(xv) Patients who may have difficulty providing effective informed consent
结局指标
主要结局
Overall survival
in resectable (R) pancreatic cancer (calculated from the first day of first-line chemotherapy)
次要结局
- Overall survival
- Progression free survival
- CY negative conversion rate
- Adverse events
- Response rate
- Disease control rate