A Randomized Phase II Study of Preoperative Chemotherapy (Gemcitabine and Erlotinib) With or Without Radiation Therapy for Patients With Resectable Adenocarcinoma of the Pancreas
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Difference in Positive Margin Resection (R1) Rate in Patients Undergo Surgery Between the Two Treatment Groups.
研究概览
简要总结
Primary Objective:
To assess margin positive resection rate (R1 resection rate; defined as "tumor within 2 mm of surgical margin on final pathology report") in patients treated with preoperative chemotherapy (gemcitabine and erlotinib) with or without external-beam radiation therapy followed by pancreaticoduodenectomy for adenocarcinoma of the pancreatic head.
Secondary Objectives:
- To assess disease free survival
- To assess overall survival
- To assess patterns of local and distant failure
详细描述
The Study Drugs:
Gemcitabine is designed to disrupt the growth of cancer cells, which may cause cancer cells to die.
Erlotinib is designed to block the activity of a protein found on the surface of many tumor cells that may control tumor growth and survival. This may stop tumors from growing.
Screening Tests:
Signing this consent form does not mean that you will be able to take part in this study. You will have "screening tests" to help the doctor decide if you are eligible to take part in this study. The following tests and procedures will be performed:
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
- •Cytologic or histologic proof of adenocarcinoma of the pancreatic head or uncinate process is required prior to treatment. Islet cell tumors are not eligible.
- •Patients must be staged with a physical exam, CXR, and contrast-enhanced CT. Only potentially resectable patients are eligible. Potentially resectable defined as: a) no extra pancreatic disease, b) no evidence (on CT) of tumor extension to the celiac axis or SMA, and c) no evidence (CT or angiogram) of occlusion of the SMV or SMPV confluence. Visceral angiography is optional. Laparoscopic staging is not part of the pretreatment evaluation for this study. Laparoscopy may be performed prior to planned laparotomy at surgeon's discretion. Staging needs to be done within 28 days of enrollment.
- •Patients cannot have known hepatic or peritoneal metastases detected by ultrasound (US), CT scan, or laparotomy prior to treatment
- •There will be no upper age restriction; patients with Karnofsky performance status greater than 70 are eligible.
- •Adequate renal, and bone marrow function: • Leukocytes >= 3,000/uL • Absolute neutrophil count >= 1,500/uL • Platelets >= 100,000/Ul • Serum creatinine <= 2.0 mg/dL
- •Hepatic function (endoscopic or percutaneous drainage as needed) • Total bilirubin < = 2 X institutional upper limits of normal (ULN) • AST (SGOT)/ALT (SGPT) <= 5 X institutional ULN
- •Patients must have no fever or evidence of infection or other coexisting medical condition that would preclude protocol therapy.
- •Pregnant women with a positive (blood B-HCG) pregnancy test are excluded from this study; women of childbearing potential (defined as those who have not undergone a hysterectomy or who have not been postmenopausal for at least 24 consecutive months) must agree to practice adequate contraception and to refrain from breast feeding, as specified in the informed consent.
- •Patients must sign a study-specific consent form, which is attached to this protocol.
排除标准
- •Tumors in the body or tail of the pancreas (to the left of the portal -SMV confluence) are not eligible.
- •Unstable angina or New York Heart Association (NYHA) Grade II or greater congestive heart failure
- •Known presence of central nervous system or brain metastases
- •Inability to comply with study and/or follow-up procedures
- •Patients < 18 years of age.
研究组 & 干预措施
Gemcitabine + Erlotinib Without Radiation
Gemcitabine + Erlotinib without radiation - Arm A: Gemcitabine 1000 mg/M^2 given intravenously over 100 min. every week for 6 doses beginning day 1 (days 1, 8, 15, 22, 29, 36) +/- 1 day. Erlotinib 100 mg daily by mouth on days 1-42.
Surgical removal of the pancreas and duodenum.
干预措施: Gemcitabine (Drug)
Gemcitabine + Erlotinib Without Radiation
Gemcitabine + Erlotinib without radiation - Arm A: Gemcitabine 1000 mg/M^2 given intravenously over 100 min. every week for 6 doses beginning day 1 (days 1, 8, 15, 22, 29, 36) +/- 1 day. Erlotinib 100 mg daily by mouth on days 1-42.
Surgical removal of the pancreas and duodenum.
干预措施: Erlotinib (Drug)
Gemcitabine + Erlotinib Without Radiation
Gemcitabine + Erlotinib without radiation - Arm A: Gemcitabine 1000 mg/M^2 given intravenously over 100 min. every week for 6 doses beginning day 1 (days 1, 8, 15, 22, 29, 36) +/- 1 day. Erlotinib 100 mg daily by mouth on days 1-42.
Surgical removal of the pancreas and duodenum.
干预措施: Surgery (Procedure)
Gemcitabine + Erlotinib With Radiation
Gemcitabine + Erlotinib with radiation - Arm B: Gemcitabine 400 mg/M^2 given intravenously over 40 min. every week for 6 doses beginning day 1 (days 1, 8, 15, 22, 29, 36) +/- 1 day. Erlotinib 100 mg daily by mouth on days 1-42. Radiation therapy 1 time each day for 5 days in a row for 5 1/2 weeks starting on Day 1 for a total of 50.4 Gy. Surgical removal of the pancreas and duodenum.
干预措施: Gemcitabine (Drug)
Gemcitabine + Erlotinib With Radiation
Gemcitabine + Erlotinib with radiation - Arm B: Gemcitabine 400 mg/M^2 given intravenously over 40 min. every week for 6 doses beginning day 1 (days 1, 8, 15, 22, 29, 36) +/- 1 day. Erlotinib 100 mg daily by mouth on days 1-42. Radiation therapy 1 time each day for 5 days in a row for 5 1/2 weeks starting on Day 1 for a total of 50.4 Gy. Surgical removal of the pancreas and duodenum.
干预措施: Radiation Therapy (Radiation)
Gemcitabine + Erlotinib With Radiation
Gemcitabine + Erlotinib with radiation - Arm B: Gemcitabine 400 mg/M^2 given intravenously over 40 min. every week for 6 doses beginning day 1 (days 1, 8, 15, 22, 29, 36) +/- 1 day. Erlotinib 100 mg daily by mouth on days 1-42. Radiation therapy 1 time each day for 5 days in a row for 5 1/2 weeks starting on Day 1 for a total of 50.4 Gy. Surgical removal of the pancreas and duodenum.
干预措施: Erlotinib (Drug)
Gemcitabine + Erlotinib With Radiation
Gemcitabine + Erlotinib with radiation - Arm B: Gemcitabine 400 mg/M^2 given intravenously over 40 min. every week for 6 doses beginning day 1 (days 1, 8, 15, 22, 29, 36) +/- 1 day. Erlotinib 100 mg daily by mouth on days 1-42. Radiation therapy 1 time each day for 5 days in a row for 5 1/2 weeks starting on Day 1 for a total of 50.4 Gy. Surgical removal of the pancreas and duodenum.
干预措施: Surgery (Procedure)
结局指标
主要结局
Difference in Positive Margin Resection (R1) Rate in Patients Undergo Surgery Between the Two Treatment Groups.
时间窗: Following resection performed at time of surgery, day 36 of treatment +/- 5 days
Difference in positive margin resection (R1) rate in patients who undergo surgery between the two treatment groups. Margin resection rate is defined as number of patients with R1 margin divided by the total number of patients who received surgery in that arm. Eligible patients will be equally (1:1 ratio) randomized to one of the two arms to receive either Gemcitabine and Erlotinib or Gemcitabine and Erlotinib and radiation as preoperative therapy. Surgery to be performed approximately 4 weeks after preoperative therapy. R1 resection defined as as tumor within 2mm of the surgical margin on the final pathology report
次要结局
未报告次要终点