JPRN-jRCTs041180051已完成2 期
Randomized phase II trial of chemoradiotherapy with S-1 versus gemcitabine and S-1 combination therapy as neoadjuvant treatment in patients with resectable pancreatic cancer - JASPAC04
esaka Katsuhiko0 个研究点目标入组 103 人开始时间: 2019年2月22日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 103
研究概览
简要总结
From May 2013 and April 2017,103 patients were enrolled. Of these, 51 patients in CRT group and 51 patients in chemotherapy group constituted the intention-to-treat analysis. The 2-year PFS rate was 45.0% (90% CI, 33.3-56.0%) in the CRT group and 54.9% (42.8-65.5%) in the chemotherapy group (p=0.52). The 2-year survival time was 66.7% (95% CI, 52.0-77.8%) in the CRT group and 72.4% (57.9-82.6%) in the chemotherapy group (p=0.33). There was no treatment-related death in both groups.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 79age old（—）
- 性别
- All
入选标准
- •1) Resectable invasive ductal carcinoma of the pancreas (according to the General Rules for the Study of Pancreatic Cancer, the sixth edition, excluding intraductal papillary mucinous carcinoma and acinar cell carcinoma) diagnosed based on the images of contrast abdominal CT scan mainly
- •2) Conformity with either a) or b) criterion
- •a) Adenocarcinoma proven by biopsy or cytology*1, which is consistent with papillary adenocarcinoma, tubular adenocarcinoma, poorly differentiated adenocarcinoma, or adenosquamous carcinoma on the imaging diagnosis
- •b) Although there is no pathological evidence, cancer is evident based on the imaging diagnosis and a high tumor marker value (only in pancreatic body and tail cancer)*2.
- •*1: Cytology of class IV or V is eligible.
- •*2: If a patient turns to be inoperable, pathological confirmation of cancer by biopsy or cytology is necessary.
- •3) A radiologist has to confirm that an estimated radiation field*3 is within 10x10 cm in size including a primary lesion and metastatic nodes (PET-positive nodes are considered to be metastatic) on abdominal CT or MRI.
- •*3: Prophylactic irradiation for regional nodes is not performed in this study.
- •4) No active gastric or duodenal ulcer
- •5) No findings of gastrointestinal invasion conformable with a) or b)
- •a) Findings of mucosal invasion of the stomach or duodenum by endoscopy
- •b) Protrusion of the tumor into the gastric or duodenal lumen by CT scan
- •6) Age of >20 or <79 years on enrollment
- •7) ECOG performance status of 0 or 1 (PS has to be written in the medical record)
- •8) Adequate oral intake
- •9) No past history of irradiation for the abdomen
- •10) No past history of chemotherapy within 3 years
- •11) No past history of treatment for pancreatic cancer
- •12) All the following conditions have to be fulfilled. All data have to be the newest and examined within 7 days prior to enrollment.
- •(1) White blood cell >3,000
- •(2) Hemoglobin >9.0 g/dL
- •(3) Platelet >100,000/mm3
- •(4) Albumin >3.0g/dL
- •(5) Total bilirubin <2.0mg/dL without biliary decompression*4 or <3.0mg/L with biliary decompression
- •(6) AST <100IU/L without biliary decompression*4 or 150IU/L with biliary decompression
- •(7) ALT <100IU/L without biliary decompression*4 or 150IU/L with biliary decompression
- •(8) Serum creatinine <1.2mg/dL
- •(9) Creatinine clearance*5 >50mL/min/body
- •*4: Percutaneous biliary drainage (PTCD, stent) or endoscopic biliary drainage (ENBD, ERBD, stent). Metallic stent is not recommended.
- •*5: Estimated creatinine clearance has to be 50mL/min or more by the Cockcroft-Gault formula. If an estimated creatinine level is below 50mlL/min, an actual measurement level of >50mL/min is required. The Cockcroft-Gault formula is following: Ccr is [(140-age)xbody weight (Kg)]/[72xserum creatinine level (mg/dL)] in men, Ccr is 0.85x[(140-age)xbody weight (Kg)]/[72xserum creatinine level (mg/dL)] in women
- •13) Written informed consent of the patient
排除标准
- •1) Past medical history of usage of gemcitabine or fluoropyrimidine drugs
- •2) Usage of flucytosine, phenytoin or warfarin potassium
- •3) Pulmonary fibrosis or interstitial pneumonia, evident by chest X-ray or symptomatic
- •4) Moderate amount of plural effusion or ascites
- •5) Watery diarrhea
- •6) Severe comorbidity (heart failure, renal failure, hepatic failure, intestinal paresis, ileus, uncontrollable diabetes mellitus, etc)
- •7) Cardiac infarction within 6 months
- •8) Active double cancer (synchronous double cancer or metachronous double cancer within 3 years excluding carcinoma in situ or mucosal cancer)
- •9) Active infectious disease excluding hepatitis B (pyrexia of over 38 degree, etc)
- •10) Blood transfusion within 2 weeks prior to enrollment
- •11) Pregnant, possibly pregnant or breast-feeding women. Men who wish his partner to be pregnant
- •12) Mental disease or mental symptom which makes participation to the study difficult
- •13) Continuous systemic steroid treatment (per-oral or infusional)
- •14) Severe drug allergy
- •15) Contraindication of both iodine-based and gadolinium-based drugs due to drug allergy
- •16) Patients who are considered inappropriate to participate this study safely by physicians
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