NCT02827201已完成2 期
Phase II Randomised Multicenter Trial Evaluating a Sequential Treatment With Nab-paclitaxel+Gemcitabine /FOLFIRI.3 vs Nab-paclitaxel + Gemcitabine in First Line Metastatic Pancreatic Cancer
Federation Francophone de Cancerologie Digestive32 个研究点 分布在 1 个国家目标入组 127 人开始时间: 2015年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 127
- 试验地点
- 32
- 主要终点
- Percentage of Patients Alive and Without Radiological and/or Clinical Progression 6 Months After the Randomization
研究概览
简要总结
The main objective of this trial is to evaluate every 2 months alternating nab-paclitaxel/gemcitabine and FOLFIRI.3 versus nab-paclitaxel + gemcitabine, regarding the progression of disease at 6 months.
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
- •Histological or cytological confirmation of pancreatic adenocarcinoma
- •Distant metastatic disease
- •Scan (or MRI if scanner contraindicated) completed within 3 weeks of the start of treatment
- •At least one lesion measurable by RECIST v1.1 criteria
- •Life expectancy> 3 months
- •No previous chemotherapy (adjuvant chemotherapy with gemcitabine authorised if administered more than 6 months prior to inclusion)
- •No previous radiotherapy (unless at least one measurable target lesion outside the irradiation zone)
- •Pain must be monitored before inclusion
- •18 years < age < 75
- •Performance status: WHO < 2
- •ANC ≥ 1500/mm3, platelets ≥ 100 000/mm3, haemoglobin ≥ 9 g/dL
- •ASAT (SGOT), ALAT (SGPT) ≤ 2.5 x ULN or ≤ 5 x ULN if liver metastases found
- •Bilirubin ≤ 1.5 x ULN (patients drained by retrograde technique are includable), creatinine < 120 μmol/L, or MDRD creatinine clearance > 60 mL/min
- •Women of childbearing age must have a negative pregnancy test (β HCG) before starting treatment
- •Women of childbearing age as well as men (who have sexual intercourse with women of childbearing age) must agree to use effective contraception without interruption for the duration of treatment and 6 months after the administration of the last treatment dose
- •Patient affiliated to the social security scheme
- •Patient information and signature of informed consent
排除标准
- •- Other types of pancreatic tumours, especially endocrine or acinar cell tumours
- •Ampulloma
- •Presence of meningeal or cerebral metastases, bone metastases
- •Gilbert's syndrome
- •Presence of neuropathy> grade 1 according to NCIC-CTC 4.0
- •Contraindications specific to the studied treatments
- •History of chronic diarrhoea or inflammatory disease of the colon or rectum, or of unresolved occlusion or sub-occlusion for which symptomatic treatment is being administered
- •Other concomitant cancer or history of cancer during the 5 years, with the exception of a carcinoma in situ of the cervix or basal cell or squamous cell carcinoma, considered cured
- •Significant history of heart or respiratory disease, including any history of interstitial pneumonia
- •Patient already included in another clinical trial with an experimental molecule
- •Women who are breast-feeding
- •Persons deprived of liberty or under guardianship
- •Unable to submit to medical monitoring during the trial due to geographical, social or psychological reasons
研究组 & 干预措施
nab-paclitaxel + gemcitabine/FOLFIRI.3
Experimental
Alternance of :
- 2 months with nab-paclitaxel (125 g/m² - 30 min in IV) + gemcitabine (1000 mg/m², 30 min in IV, 3 injections follow by 1 week free)
- follow by 2 months with FOLFIRI.3 (irinotecan: 90 mg/m² at D1, acid folinic 400 mg/m², 5Fu continus: 2000 mg/m² IV 46 hours, and irinotecan at D3, 90 mg/m²) This alternance continus until progression
干预措施: FOLFIRI.3 (Drug)
nab-paclitaxel + gemcitabine/FOLFIRI.3
Experimental
Alternance of :
- 2 months with nab-paclitaxel (125 g/m² - 30 min in IV) + gemcitabine (1000 mg/m², 30 min in IV, 3 injections follow by 1 week free)
- follow by 2 months with FOLFIRI.3 (irinotecan: 90 mg/m² at D1, acid folinic 400 mg/m², 5Fu continus: 2000 mg/m² IV 46 hours, and irinotecan at D3, 90 mg/m²) This alternance continus until progression
干预措施: nab-paclitaxel+ gemcitabine (Drug)
nab-paclitaxel + gemcitabine
Active Comparator
nab-paclitaxel (125 g/m² - 30 min in IV) + gemcitabine (1000 mg/m² - 30 min in IV) 3 injections follow by 1 week free, until progression
干预措施: nab-paclitaxel+ gemcitabine (Drug)
结局指标
主要结局
Percentage of Patients Alive and Without Radiological and/or Clinical Progression 6 Months After the Randomization
时间窗: 6 months after randomization
The primary endpoint was the rate of patients alive and progression-free 6 months after randomization. Progression was assessed by the investigator and defined radiologically according to RECIST v1.1 criteria and/or clinically as deterioration of general condition not related to treatment, palpable tumor masses on clinical examination (adenopathy, tumor hepatomegaly, peritoneal carcinosis), pleural effusion, ascites. Patients who progressed or died before 6 months were considered to have failed the primary endpoint at 6 months. The 6-month imaging was the imaging done at 6 months with a +/- 1 month window.
次要结局
- Best Response(Up to the end of treatment on the average of 12 months)
- Progression-free Survival (PFS)(up to 12 months after randomization)
- Overall Survival (OS):(Up to 2 years after the treatment start)
研究者
研究点 (32)
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