A Phase II Study Induction Chemotherapy, Neoadjuvant Chemoradiotherapy, Surgical Resection and Adjuvant Chemotherapy for Patients With Locally Advanced, Resectable Pancreatic Adenocarcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Median Overall Survival of Patients With Adenocarcinoma of the Pancreas
研究概览
简要总结
This phase II trial studies how well giving combination chemotherapy together with intensity-modulated radiation therapy (IMRT) and surgery works in treating patients with localized pancreatic cancer that can be removed by surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride, docetaxel, capecitabine, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy, such as IMRT, that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving more than one drug (combination chemotherapy) together with intensity-modulated radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery.
详细描述
PRIMARY OBJECTIVES:
I. To estimate the median overall survival of patients with adenocarcinoma of the pancreas treated with induction chemotherapy, neoadjuvant chemoradiotherapy, surgical resection and adjuvant chemotherapy.
SECONDARY OBJECTIVES:
I. To determine the percent of patients surviving at annual intervals through five years.
II. To determine the median recurrence free survival following pancreaticoduodenectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Patients must have histologically or cytologically confirmed diagnosis of localized, resectable or borderline resectable, pancreatic adenocarcinoma T1-T3, N0-N1, M0; stage is determined by helical multi-phase computed tomography (CT) and/or endoscopic ultrasound according to published guidelines; resectability is determined by the treating surgeon and published guidelines (National Comprehensive Cancer Network)
- •Resectable Disease- Head/Body/Tail of pancreas:
- •No distant metastases
- •Clear fat plane around celiac and superior mesenteric arteries (SMA)
- •Patent superior mesenteric vein (SMV) and portal vein (PV)
- •Borderline Resectable Disease -Head/Body of pancreas:
- •Tumor abutment on SMA
- •SMV/portal vein impingement or occlusion if involving only a short segment, with open vein both proximally and distally (if proximal vein is occluded up to the portal vein branches then disease is unresectable)
- •Colon or mesocolon invasion
- •Gastroduodenal artery (GDA) encasement up to origin at hepatic artery
- •Tail of pancreas:
- •Adrenal, colon or mesocolon, or kidney invasion
- •Preoperative evidence of biopsy-positive peripancreatic lymph node
- •No prior therapy for pancreatic cancer
- •Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
- •Leucocytes >= 3,000/uL
- •Absolute Neutrophil Count >= 1,500/uL
- •Platelets >= 100,000/uL
- •Total Bilirubin:
- •If within normal limits (WNL) to =< 2.0, the subject is eligible
- •If > 2.0 - < 6.0, subject is eligible IF they have a biliary stent and total bilirubin is decreasing
- •If >= 6.0, subject is not eligible
- •Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT)(serum glutamate pyruvic transaminase [SGPT]) =< 2.5 X institutional upper limit of normal or =< 1.5 X upper limit of normal (ULN) if alkaline phosphatase (Alk Phos) > 2.5 X ULN or if the subject has a biliary stent and the liver function tests (LFTs) are decreasing the subject is eligible
- •Creatinine clearance >= 30%
- •Negative pregnancy test for women of childbearing potential; women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
- •Ability to swallow and retain oral medication
- •Ability to understand and willingness to sign a written informed consent document
排除标准
- •Patients may not be receiving any other investigational agents
- •Histology other than adenocarcinoma
- •Patients with permanently unresectable pancreatic adenocarcinoma as determined by the treating physician and published guidelines (National Comprehensive Cancer Network)
- •Unresectable disease
- •Head of pancreas:
- •Distant metastases (includes celiac and/or para-aortic)
- •SMA, celiac encasement
- •SMV/portal occlusion
- •Aortic, inferior vena cava (IVC) invasion or encasement
- •Invasion of SMV below transverse mesocolon
- •Body of pancreas:
- •Distant metastases (includes celiac and/or para-aortic); at the discretion of the treating surgeon, body and tail lesions that have positive celiac and/or para-aortic nodes in close vicinity to the primary may be borderline rather than unresectable
- •SMA, celiac, hepatic encasement
- •SMV/portal extended occlusion
- •Aortic invasion
- •Tail of pancreas:
- •Distant metastases (includes celiac and/or para-aortic)
- •SMA, celiac encasement
- •Rib, vertebral invasion
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine, docetaxel, capecitabine, oxaliplatin or other agents used in the study
- •Patients who have received prior chemotherapy or radiotherapy for the diagnosis of pancreatic cancer
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- •Inability to comply with study and/or follow-up procedures
- •Pregnancy or lactation
- •Human immunodeficiency virus (HIV)-positive patients receiving combination anti-retroviral therapy
研究组 & 干预措施
Treatment (chemotherapy, radiation, pancreaticoduodenectomy)
See Detailed Description
干预措施: gemcitabine hydrochloride (Drug)
Treatment (chemotherapy, radiation, pancreaticoduodenectomy)
See Detailed Description
干预措施: docetaxel (Drug)
Treatment (chemotherapy, radiation, pancreaticoduodenectomy)
See Detailed Description
干预措施: capecitabine (Drug)
Treatment (chemotherapy, radiation, pancreaticoduodenectomy)
See Detailed Description
干预措施: intensity-modulated radiation therapy (Radiation)
Treatment (chemotherapy, radiation, pancreaticoduodenectomy)
See Detailed Description
干预措施: oxaliplatin (Drug)
Treatment (chemotherapy, radiation, pancreaticoduodenectomy)
See Detailed Description
干预措施: pancreatic surgical procedure (Procedure)
Treatment (chemotherapy, radiation, pancreaticoduodenectomy)
See Detailed Description
干预措施: therapeutic conventional surgery (Procedure)
Treatment (chemotherapy, radiation, pancreaticoduodenectomy)
See Detailed Description
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Median Overall Survival of Patients With Adenocarcinoma of the Pancreas
时间窗: 5 years
Time at which Kaplan-Meier estimate of overall survival drops below 50%
次要结局
- Percent of Patients Surviving at 5 Years(Up to 5 years)
- Median Recurrence Free Survival Following Pancreaticoduodenectomy(From the date of pancreaticoduodenectomy to date of first observation of radiographic recurrence or death due to any cause, assessed up to 7 years)
- Clinical Response Rate to Neoadjuvant Chemotherapy and Chemoradiotherapy(Up to 7 years)
- Pathologic Response Rate (Complete, Near-complete, Partial) to Neoadjuvant Chemotherapy and Chemoradiotherapy(Up to 7 years)
- CA 19-9 Tumor Marker Response Rate to Neoadjuvant Chemotherapy and Chemoradiotherapy(Up to 26 weeks after surgery)
- Surgical Completion Rate and Complication Rate(Up to 6 weeks following the completion of chemoradiotherapy)
- Frequency and Severity of Toxicities Associated With This Treatment Regimen as Assessed by NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0(Up to 26 weeks after surgery (the end of adjuvant chemotherapy))
- Percent of Patients Surviving at Annual Intervals(5 years)
研究者
Andrew Coveler
Principal Investigator
University of Washington