JPRN-jRCT1051190064已完成2 期
Phase II study of neoadjuvant chemoradiotherapy with gemcitabine and IMRT for patients with resectable pancreatic cancer
Masui Toshihiko0 个研究点目标入组 54 人开始时间: 2019年10月16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
- 54
研究概览
简要总结
A single-arm exploratory phase II trial of preoperative gemcitabine plus intensity-modulated radiation for resectable pancreatic cancer showed a median overall survival of 49.8 months, more or less equivalent to the current standard of care of 36.1 months for preoperative chemotherapy. The secondary endpoint, AEs, were not serious, indicating that the trial can be performed safely.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 < 80age old（—）
- 性别
- All
入选标准
- •1. Primary tumor is confirmed to be pancreatic cancer from histology or cytology
- •2. No distant metastasis
- •3. Cases matching RPC expected to curative resection (R0 or R1). T1-3, stageIA-IIB according to UICC TNM classification
- •4. Age 20-80 years
- •5. ECOG Performance status 0 or 1
- •6. Capable of radical surgery
- •7. No previous treatment for pancreatic cancer
- •8. Capable of oral intake
- •No clinical problems in ECG (latest value within 28 days before registration).
- •9. Main organs functions meet the following criteria
- •Leukocytes >=3500 <12,000/mm3, Neutrophil>= 2000/mm3, Hemog lobin >= 9.0 g /dL, Platelets >= 100,000/mm3, Total bilirubin < 2.0 mg /dL (<= 3.0 mg /dl in biliary drainage case), AST/ALT <= 150 U/L, Serum creatinine <= 1.2 mg /dL, Ccr >=50mL/min
- •10. Signed and dated informed consent before enrollment.
排除标准
- •1. Interstitial pneumonia or pulmonary fibrosis (latest evaluation by CT within 28 days before reg istration)
- •2. Prior history of radiation treatment in the upper abdomen and evaluated as inappropriate for the neoadjuvant chemoradiation.
- •3. Severe comorbidities (heart failure, renal failure, liver failure, hemorrhagic peptic ulcer, paralytic ileus, ileus, uncontrollable diabetes mellitus)
- •4. Uncontrollable pleural effusion or ascites that needs puncture
- •5. active malignant tumors (including that without recurrence in the past three years) Intramucosal carcinoma and carcinoma in situ are not dealt as active malignant tumors
- •6. Breast-feeding or pregnant, possibly pregnant, or women who do not agree to prevent conception, and both men and women without intention to use contraception during the period of the study
- •7. Cases with severe mental disorders
- •8. Additional cases the doctor deems inappropriate for the participation of the clinical trial
研究者
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