Phase 2 Evaluation of a Community-Based Multi-modality Management Algorithm for Clinically Non-metastatic Ductal Adenocarcinoma of the Exocrine Pancreas or Ampulla
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Relapse Free Survival
研究概览
简要总结
Patients diagnosed with pancreatic cancer without clinically detectable metastatic disease will be treated with standardized systemic chemotherapy, followed by chemoradiation, and then surgical resection for those with resectable or borderline resectable disease. The primary endpoint is disease-free survival at 1 yr from initiation of treatment.
详细描述
Patients with ductal adenocarcinoma of the pancreas (or ampulla) that have received no prior therapy and have no clinically detectable metastatic disease will be enrolled. Management will be driven by resectability status as defined by the American College of Surgeons. All patients will be defined at entry as Resectable, Borderline Resectable or Locally Advanced (Unresectable).
All patients will be treated initially with gemcitabine and nanoparticle albumin bound paclitaxel (nab-paclitaxel) every 14 days for 4 cycles. Patients classified as Resectable, who have CA19-9 below 180 and CA-125 below 30 will then proceed to resection. All other patients will get 5-fluorouracil as 46 hr infusion given with leucovorin and irinotecan (FOLFIRI-3) every 14 days x 4 cycles.
All patients without progression will then receive chemoradiation consisting of external beam radiotherapy (40 Gy in 20 fractions given over 4 weeks). During radiation all patients will receive radiosensitizing radiotherapy as: 5-fluorouracil at 225 mg/m2 5 days per week, Mitomycin-C at 3 mg.m2 on d1, 8, 15 & 22; Cisplatin at 10 mg/m2 on d2, 9, 16, 23 and unfractionated heparin at 6,000 units/m2 daily in divided doses from day 1 to day 28.
After approximately 4 weeks to recover from chemoradiation, all patients with Resectable or Borderline Resectable disease will undergo definitive surgery.
Adjuvant therapy with FOLFIR-3 for an additional 6 cycles will be offered to all patients post-operatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologic proof of adenocarcinoma consistent with ductal carcinoma of pancreas or ampulla, with no evidence of metastatic disease by clinical exam or cross-sectional imaging.
- •Fitness for chemotherapy in judgement of treating physician
- •Bilirubin < 4 (any means of biliary drainage acceptable)
排除标准
- •Medical or mental illness precluding provision of informed consent
- •Pregnancy
- •Active infection for which neutropenia would pose high risk of mortality
研究组 & 干预措施
Resectable, Low Risk
Systemic chemotherapy followed by definitive surgery without pre-operative or post-operative radiotherapy.
干预措施: Gemcitabine and nanoparticle albumin bound paclitaxel (Drug)
Resectable, Low Risk
Systemic chemotherapy followed by definitive surgery without pre-operative or post-operative radiotherapy.
干预措施: Definitive resection (Procedure)
Locally Advanced
Systemic chemotherapy followed by chemoradiation, followed by definitive surgery
干预措施: Gemcitabine and nanoparticle albumin bound paclitaxel (Drug)
Locally Advanced
Systemic chemotherapy followed by chemoradiation, followed by definitive surgery
干预措施: 5-fluorouracil and irinotecan (Drug)
Locally Advanced
Systemic chemotherapy followed by chemoradiation, followed by definitive surgery
干预措施: Preoperative chemoradiation (Radiation)
Locally Advanced
Systemic chemotherapy followed by chemoradiation, followed by definitive surgery
干预措施: Definitive resection (Procedure)
结局指标
主要结局
Relapse Free Survival
时间窗: 1 yr form onset of treatment
Percentage of patients alive and free of detectable disease 1 yr from start of treatment
次要结局
- Overall Survival(Up to 3 years from registration)
- R-0 Rate(Time of surgery)