Induction Chemotherapy, Fluorouracil, Leucovorin, Oxaliplatin and Irinotecan (FOLFIRINOX) Followed With Concurrent Capecitabine and Radiation Therapy in Treatment of Patients With Inoperable Locally Advanced Cancer Pancreas
试验速览
- 阶段
- 2 期
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability of FOLFIRINOX plus Concurrent Radiotherapy with Capecitabine
研究概览
简要总结
This prospective cohort, phase II, trial is studying induction chemotherapy combination, FOLFIRINOX regimen, consisted of oxaliplatin, irinotecan, leucovorin and fluorouracil (5-FU), for 4 cycles, followed by consolidation concurrent radiotherapy with capecitabine in non-progressed cases, in treating patients with locally advanced cancer pancreas.
详细描述
Design & Methodology:
- Nature of the study:
It is ( prospective cohort study). 2. Study subjects:
*Target Population: Patients, fulfilling the inclusion criteria for the research, will be selected from Assiut clinical oncology department in Assiut University Hospitals.
- Sample size:
20 patients.
- Characteristics of subjects:
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Disease characteristics:
- •Histological and radiological confirmation of locally advanced cancer pancreas
- •Inoperable disease
- •Disease must be able to be encompassed within a radical radiotherapy treatment volume
- •Not metastatic
- •Patient characteristics:
- •ECOG performance status 0 or 1
- •Life expectancy > 3 months.
- •Glomerular filtration rate ≥ 60 mL/min.
- •WBC > 3,000/mm³.
- •Absolute neutrophil count > 1,500/mm³.
- •Hemoglobin > 10.0 g/dL.
- •Platelet count > 100,000/mm³.
- •Alkaline phosphatase ≤ 1.5 times upper limit of normal (ULN)
- •Gamma-glutamyl-transferase < 1.5 times ULN.
- •Transaminases ≤ 1.5 times ULN.
- •Bilirubin ≤ 1.5 times ULN.
- •No medically unstable conditions (e.g., unstable diabetes, uncontrolled arterial hypertension, infection, hypercalcemia, or ischemic heart disease)
- •Not pregnant or nursing.
- •No other previous or current malignant disease likely to interfere with protocol treatment or comparisons
- •No prior chemotherapy or radiotherapy.
排除标准
- •ECOG performance status > 2
- •Life expectancy < 3 months.
- •Glomerular filtration rate < 30 mL/min.
- •Absolute neutrophil count < 1,500/mm³.
- •Alkaline phosphatase > 1.5 times upper limit of normal (ULN)
- •Gamma-glutamyl-transferase > 1.5 times ULN.
- •Transaminases>1.5 times ULN.
- •Bilirubin >1.5 times ULN.
- •medically unstable conditions (e.g., unstable diabetes, uncontrolled arterial hypertension, infection, hypercalcemia, or ischemic heart disease)
- •pregnant or nursing.
- •prior chemotherapy or radiotherapy.
研究组 & 干预措施
FOLFIRINOX + CRT
FOLFIRINOX regimen, consisted of oxaliplatin, irinotecan, leucovorin and fluorouracil (5-FU), for 4 cycles, followed by consolidation radiotherapy concurrent with capecitabine 625mg/m2 BID in non-progressed cases, in treating patients with locally advanced cancer pancreas.
干预措施: FOLFIRINOX + CRT (Drug)
结局指标
主要结局
Number of Participants with Adverse Events as a Measure of Safety and Tolerability of FOLFIRINOX plus Concurrent Radiotherapy with Capecitabine
时间窗: 6 months after enrolment
will be carried out, using (CTCAE) Common Terminology Criteria for Adverse Events, Version 4.0
次要结局
- Tumor response(6 months after enrolment)
研究者
Ahmed Allam Abdelhamed Mohamed
Dr
Assiut University