Phase II Study of Oxaliplatin, Continuous 5-Fluorouracil and External Beam Radiation Followed by Gemcitabine in Patients With Locally Advanced Pancreatic Cancer
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
- 1-year survival rate
研究概览
简要总结
This phase II trial is studying how well giving radiation therapy together with oxaliplatin and fluorouracil followed by gemcitabine works in treating patients with locally advanced, unresectable pancreatic cancer. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy, such as oxaliplatin, fluorouracil, and gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Oxaliplatin may also make the tumor cells more sensitive to radiation therapy. Giving radiation therapy with chemotherapy may kill more tumor cells.
详细描述
PRIMARY OBJECTIVES:
I. Determine the 1-year survival rate in patients with locally advanced, unresectable adenocarcinoma of the pancreas treated with concurrent external beam radiotherapy, oxaliplatin, and fluorouracil followed by gemcitabine.
SECONDARY OBJECTIVES:
I. Determine overall survival, time to disease progression, and confirmed response rate in patients treated with this regimen.
II. Determine toxicity of this regimen in these patients.
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
- •Histologically or cytologically confirmed adenocarcinoma of the pancreas
- •Unresectable disease, including subtotal resection and gross residual disease
- •Locally advanced disease
- •No cystadenocarcinoma of the pancreas
- •No pancreatic tumors of neuroendocrine origin
- •No microscopic residual disease as only evidence of pancreatic cancer
- •All disease must be encompassable within standard radiotherapy fields for pancreatic cancer
- •No distant metastases (liver or lung metastases or peritoneal spread)
- •No evidence of metastatic disease outside the planned radiotherapy field
- •Performance status - ECOG 0-1
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Hemoglobin ≥ 9.0 g/dL
- •Bilirubin ≤ 2 times upper limit of normal (ULN)
- •AST ≤ 3 times ULN
- •Creatinine ≤ 1.5 times ULN
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •Able to maintain adequate oral nutrition
- •No significant infection
- •No significant nausea or vomiting
- •No other medical condition that would preclude study participation
- •No other malignancy within the past 3 years except nonmelanoma skin cancer, carcinoma in situ of the cervix, or organ-confined prostate cancer (Gleason score < 7)
- •No known allergy to platinum compounds
- •No prior biologic therapy
- •No concurrent biologic therapy
- •No concurrent immunotherapy
- •No prior chemotherapy
- •No other concurrent chemotherapy
- •No prior radiotherapy that would overlap planned radiotherapy fields
- •No other concurrent radiotherapy
- •See Disease Characteristics
- •At least 21 days since prior laparotomy
排除标准
- 未提供
研究组 & 干预措施
Arm I
Patients undergo radiotherapy once daily, 5 days a week, for 5.5 weeks. Beginning concurrently with radiotherapy, patients receive oxaliplatin IV over 2 hours on days 1, 15, and 29 and fluorouracil IV continuously for 5.5 weeks. Beginning 4-6 weeks after the completion of chemoradiotherapy, patients receive gemcitabine IV over 30 minutes on days 1 and 8. Treatment with gemcitabine repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
干预措施: radiation therapy (Radiation)
Arm I
Patients undergo radiotherapy once daily, 5 days a week, for 5.5 weeks. Beginning concurrently with radiotherapy, patients receive oxaliplatin IV over 2 hours on days 1, 15, and 29 and fluorouracil IV continuously for 5.5 weeks. Beginning 4-6 weeks after the completion of chemoradiotherapy, patients receive gemcitabine IV over 30 minutes on days 1 and 8. Treatment with gemcitabine repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
干预措施: oxaliplatin (Drug)
Arm I
Patients undergo radiotherapy once daily, 5 days a week, for 5.5 weeks. Beginning concurrently with radiotherapy, patients receive oxaliplatin IV over 2 hours on days 1, 15, and 29 and fluorouracil IV continuously for 5.5 weeks. Beginning 4-6 weeks after the completion of chemoradiotherapy, patients receive gemcitabine IV over 30 minutes on days 1 and 8. Treatment with gemcitabine repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
干预措施: fluorouracil (Drug)
Arm I
Patients undergo radiotherapy once daily, 5 days a week, for 5.5 weeks. Beginning concurrently with radiotherapy, patients receive oxaliplatin IV over 2 hours on days 1, 15, and 29 and fluorouracil IV continuously for 5.5 weeks. Beginning 4-6 weeks after the completion of chemoradiotherapy, patients receive gemcitabine IV over 30 minutes on days 1 and 8. Treatment with gemcitabine repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
干预措施: gemcitabine hydrochloride (Drug)
结局指标
主要结局
1-year survival rate
时间窗: At 1 year
1-year survival will be considered "success". The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. If more than 1 patients is lost to follow-up, we will use Kaplan-Meier estimates for the 6-month and 12-month overall survival rates. 95% confidence intervals for the true success proportion will be calculated according the approach of Duffy and Santner.
次要结局
- Survival time(Time from registration to death due to any cause, assessed up to 3 years)
- Confirmed tumor response, defined to be a CR or PR noted as the objective status on 2 consecutive evaluations at least 4 weeks apart(Up to 6 months)
- Time to disease progression(Time from registration to documentation of disease progression, assessed up to 3 years)
- Duration of response(Date at which the patient's objective status is first noted to be either a CR or PR to the date progression is documented, assessed up to 3 years)
- Time to treatment failure(Time from the date of randomization to the date at which the patient is removed from treatment due to progression, toxicity, or refusal, assessed up to 3 years)