A Feasibility Phase II Study of Gemcitabine With Docetaxel With Concurrent 3-D Conformal Radiation Plus Continuous Infusion 5-Fluorouracil in the Treatment of Resected Cholangiocarcinoma, Gallbladder, Pancreatic and Ampullary Cancers
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Incidence of Severe Toxicities
研究概览
简要总结
To assess the feasibility of administering induction chemotherapy with gemcitabine and docetaxel followed by concurrent radiation and continuous infusion 5FU and consolidation gemcitabine/docetaxel chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 biopsy-proven, resected with curative intent cholangiocarcinoma, gallbladder, pancreatic or ampullary adenocarcinoma.
- •Patients must be 18 years or older.
- •Patients must have a NCI CTC Performance Status of 0-
- •Patients must not have any prior chemotherapy or radiation therapy for this current malignancy.
- •At least 3 weeks should have elapsed since any surgery requiring general anesthesia.
- •Patients must have no prior malignancies except for basal or squamous skin cancers, cervical carcinoma-in-situ, unless in remission for >5years
- •Pregnant patients are not eligible. Non-pregnant status will be determined in all women of childbearing potential. All patients will be required to use an effective means of contraception if sexually active during therapy.
- •Initial Required Laboratory Values:
- •Absolute neutrophil count ≥ 1,500/mm3, platelet count ≥ 150, 000/mm3, and hemoglobin ≥ 9 g/dL.
- •Serum creatinine should be ≤ 2 mg/dL.
- •Serum bilirubin should be ≤ 3.0 mg/dL (biliary stents allowed).
- •Serum transaminases should be ≤ 5-fold the institutional upper limits.
- •Patients must not have any co-existing severe medical illnesses, such as unstable angina, uncontrolled diabetes mellitus, uncontrolled arrhythmia or uncontrolled infection.
- •Patients must be able to sign an informed consent.
排除标准
- 未提供
研究组 & 干预措施
Arm 1 (gemcitabine, docetaxel, 5FU, radiation)
Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles
Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles
5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2)
Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week.
Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)
Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)
干预措施: Gemcitabine (Drug)
Arm 1 (gemcitabine, docetaxel, 5FU, radiation)
Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles
Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles
5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2)
Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week.
Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)
Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)
干预措施: Docetaxel (Drug)
Arm 1 (gemcitabine, docetaxel, 5FU, radiation)
Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles
Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles
5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2)
Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week.
Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)
Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation)
干预措施: Radiation (Radiation)
结局指标
主要结局
Incidence of Severe Toxicities
时间窗: 1 month after completion of treatment (treatment lasts approximately 19 weeks)
Toxicity was graded according to National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 2.0
次要结局
- Toxicities Associated With Treatment (Grade 1-2)(30 days after completion of treatment (treatment lasts approximately 19 weeks))
- Disease Free Survival (DFS) - Median(Median follow-up was 24 months (range 3.2-97 months))
- Overall Survival (OS) - Median(Median follow-up was 24 months (range 3.2-97 months))
- Overall Survival (OS)(2 years)
- Toxicities Associated With Treatment (Grade 3-4)(30 days after completion of treatment (treatment lasts approximately 19 weeks))