Perioperative Chemotherapy Prior To and After Reoperation for Incidental Gallbladder Cancer - An International, Randomized Phase III Trial
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 5
- 主要终点
- Overall survival
研究概览
简要总结
This phase III trial studies how well chemotherapy before and after surgery works in treating participants with gallbladder cancer that can be removed by surgery. Drugs used in chemotherapy, such as cisplatin, gemcitabine, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before and after surgery may kill more tumor cells.
详细描述
PRIMARY OBJECTIVE:
I. To determine the difference in overall survival (OS) at 3 years for patients with incidental gallbladder cancer (IGBC) who receive neoadjuvant gemcitabine hydrochloride (gemcitabine) and cisplatin (gem/cis) prior to reoperation followed by adjuvant capecitabine compared to patients who receive only adjuvant capecitabine after reoperation.
SECONDARY OBJECTIVES:
I. To determine the difference in recurrence-free survival (RFS) at 1 year for patients with IGBC who receive perioperative chemotherapy prior to and after re-operation compared to patients who receive only adjuvant chemotherapy after reoperation.
II. To assess the clinical effect of perioperative chemotherapy compared to only adjuvant chemotherapy after reoperation on resectability among 3 cohorts: all enrolled patients, all patients who undergo staging laparoscopy, and all patients who undergo laparotomy.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically-confirmed T1b, T2 or T3 gallbladder cancer discovered incidentally at the time of or following routine cholecystectomy for presumed benign disease
- •Resectable disease at the time of enrollment based on high-quality, preoperative, cross-sectional imaging of the chest, abdomen, and pelvis (C/A/P)
- •Enrollment and randomization within 12 weeks of initial cholecystectomy
- •High-quality cross-sectional imaging (computed tomography [CT] or magnetic resonance imaging [MRI]) performed within 4 weeks prior to enrollment
- •Able to give informed consent
- •Able to adhere to study visit schedule and other protocol requirements
- •Eastern Cooperative Oncology Group (ECOG) performance status of < 2
- •Absolute neutrophil count ≥ 1500/mm³
- •Platelet count ≥ 100,000/mm³
排除标准
- •Patients with histologically-confirmed Tis, T1a, or T4 tumors
- •Unresectable gallbladder cancer at the time of enrollment based on high-quality, preoperative, cross-sectional imaging of the C/A/P
- •Unable to sign informed consent
- •Serum creatinine > 1.5 x upper limit of normal or estimated creatinine clearance (CrCl) < 45 ml/min
- •Serum total bilirubin > 1.5 x upper limit of normal
- •Presence of active infection
- •Pregnant and/or breastfeeding
- •Known dihydropyrimidine dehydrogenase deficiency
研究组 & 干预措施
Arm I (capecitabine)
Participants undergo re-resection (including partial liver resection and portal lymph node dissection). Participants then receive capecitabine PO BID on days 1-14. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
干预措施: Capecitabine (Drug)
Arm II (chemotherapy, capecitabine)
Participants receive cisplatin IV over 1 hour and gemcitabine IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Within 10 weeks of chemotherapy, participants undergo re-resection (including partial liver resection and portal lymph node dissection). Participants then receive capecitabine PO BID on days 1-14. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
干预措施: Capecitabine (Drug)
Arm II (chemotherapy, capecitabine)
Participants receive cisplatin IV over 1 hour and gemcitabine IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Within 10 weeks of chemotherapy, participants undergo re-resection (including partial liver resection and portal lymph node dissection). Participants then receive capecitabine PO BID on days 1-14. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
干预措施: Cisplatin (Drug)
Arm II (chemotherapy, capecitabine)
Participants receive cisplatin IV over 1 hour and gemcitabine IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Within 10 weeks of chemotherapy, participants undergo re-resection (including partial liver resection and portal lymph node dissection). Participants then receive capecitabine PO BID on days 1-14. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
干预措施: Gemcitabine (Drug)
结局指标
主要结局
Overall survival
时间窗: Up to 3 years after study start
Overall survival (OS) is defined as time from randomization to death from any cause.
次要结局
- Resectability rate at laparotomy(Up to 3 years after study start)
- Overall resectability rate(Up to 3 years after study start)
- Recurrence-free survival(From surgery to first observed disease recurrence or death from any cause, assessed at 1 year)
- Resectability rate at diagnostic laparoscopy(Up to 3 years after study start)
- Incidence of residual disease after or at the time of re-resection(Up to 3 years after study start)
研究者
Shishir Kumar Maithel
Principal Investigator
Emory University