JPRN-jRCTs031180085已完成2 期
JCOG1407: Randomized phase II study of modified FOLFIRINOX versus gemcitabine plus nab-paclitaxel combination therapy for locally advanced pancreatic cancer - LAPC-mFOLFIRINOX/GnP-rP2
Furuse Junji0 个研究点目标入组 126 人开始时间: 2019年1月17日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 126
研究概览
简要总结
There was no substantial difference in efficacy and safety between modified FOLFIRINOX and gemcitabine plus nab-paclitaxel for locally advanced pancreatic cancer. The efficacy of both modified FOLFIRINOX and gemcitabine plus nab-paclitaxel is superior to that of gemcitabine alone, suggesting that modified FOLFIRINOX and gemcitabine plus nab-paclitaxel are the standard chemotherapy for locally advanced pancreatic cancer.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 75age old（—）
- 性别
- All
入选标准
- •1) Histologically or cytologically proven adenocarcinoma and consistent with papillary adenocarcinoma, tubular adenocarcinoma, poor differentiated adenocarcinoma, or adenosquamous carcinoma by diagnostic imaging
- •2) Without obvious organ metastasis (M0) by chest CT and enhanced abdominal/pelvic CT
- •3) Diagnosed as UICC-T4 or UICC-T3 with invasion to common hepatic artery, hepatic artery proper, or portal vein by enhanced abdominal and pelvic CT
- •4) Without ascites/pleural effusion by chest CT and enhanced abdominal/pelvic CT
- •5) A measurable lesion is not required
- •6) Age from 20 to 75 years
- •7) ECOG performance status of 0 or 1
- •8) No diarrhea
- •9) No peripheral sensory neuropathy and peripheral motor neuropathy
- •10) No prior surgical treatment for pancreatic cancer
- •11) No previous chemotherapy or radiotherapy for other malignancies
- •12) UGT1A1 genotype of neither *6/*6, *28/*28, nor *6/*28
- •13) Adequate function of major organs
- •14) Written informed consent
排除标准
- •1) Synchronous or metachronous (within 5 years) malignancies.
- •2) Infectious disease requiring systemic treatment (excluding hepatitis viral).
- •3) Pyrexia of 38 degrees centigrade or higher.
- •4) Female during pregnancy, within 28 days of postparturition, or during lactation and male expecting partner's pregnancy.
- •5) Severe psychological disorder.
- •6) Receiving continuous systemic corticosteroid or immunosuppressant treatment.
- •7) Interstitial pneumonia, pulmonary fibrosis, or severe emphysema on chest CT
- •8) Severe comorbidities (such as heart failure, renal failure, hepatic failure, paresis of intestine, illeus, poorly controlled diabetes and poorly controlled hypertension)
- •9) History of unstable angina pectoris with new onset or exacerbation within recent 3 weeks or myocardial infarction within 6 months before registration.
- •10) Allergy to iodine and gadolinium
研究者
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