Significance of Chemoradiation Following Induction Chemotherapy in Locally Advanced,Unresectable Pancreatic Cancer -a Randomised Phase 3 Trial: Chemoradiation Following Induction Chemotherapy Compared With Chemotherapy Alone
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 830
- 试验地点
- 23
- 主要终点
- Overall survival
研究概览
简要总结
This randomized trial examines the effectiveness of chemoradiotherapy compared to chemotherapy alone after induction chemotherapy with 3 cycles of gemcitabine or 6 cycles of FOLFIRINOX in patients with locally advanced, non resectable and non-metastatic pancreatic cancer. Chemotherapeutic agent in chemoradiotherapy is gemcitabine administered in 5 cycles, the agent and its administration for sole chemotherapy is determined by induction chemotherapy. Operability of tumor is evaluated at week 11 after randomisation. Patients will be followed for the duration of therapy and for 5 years after the last study treatment. Overall survival at the end of follow up is defined as primary endpoint. Secondary endpoints are tumor-free survival, rate of local recurrence or local progression, rate of distant metastasis, acute and late toxicity of the chemoradiotherapy, quality of life, rate of remission, rate of curative resections (R0) after chemotherapy and chemoradiotherapy. It is planned to include a total number of 830 patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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
- •Age > 18 years
- •histologically confirmed adenocarcinoma of the pancreas
- •no evidence of distant metastasis based on computed tomography of the thorax and abdomen
- •non resectable pancreatic cancer
- •no evidence of peritoneal carcinosis
- •ECOG-performance status ≤ 2
- •signed study-specific consent form prior to therapy
排除标准
- •fertile patients who refuse effective contraception during study treatment
- •synchron second malignant neoplasm except basal cell carcinoma of the skin and carcinoma in situ of the cervix after curative therapy
- •the Inclusion of patients with prior or concurrent malignancy (≤ 5 years prior to enrolment in study) must be discussed
- •chronic inflammatory disease of the intestine
- •known allergic reactions on study medication
- •on-treatment participation on other trials
- •insufficient liver function: Bilirubin > 2,0 mg/dl; SGOT, SGPT, alkaline phosphatase, gGT more than 3 times upper limit of normal (after Stent implantation in case of obstructive jaundice); cirrhosis of the liver Child B and C
- •insufficient bone marrow function: WBC < 3,0 x 10^9/l, Platelets > 100 x 10^9/l
- •serum creatinine > 1,5 mg/dl, creatinin clearance < 60ml/min (or comparable test)
- •preexisting uncontrolled cardiac disease, signs of cardiac failure, or rhythm disturbances requiring therapy, myocardial infarction within the past 6 months, unstable angina pectoris, congestive heart failure, New York Heart Association (NYHA) class III or IV heart disease
- •neurological and/or psychiatric diseases: stroke, dementia, epilepsy, psychosis
- •active intractable or uncontrollable infection, HIV-infection
- •prior radiotherapy or chemotherapy
研究组 & 干预措施
Induction CT, chemoradiotherapy
Induction chemotherapy with gemcitabine or FOLFIRINOX; Radiotherapy, 28 x 1.8 Gy; Chemotherapy, gemcitabine;
干预措施: Induction chemotherapy with gemcitabine or FOLFIRINOX (Drug)
Induction CT, chemoradiotherapy
Induction chemotherapy with gemcitabine or FOLFIRINOX; Radiotherapy, 28 x 1.8 Gy; Chemotherapy, gemcitabine;
干预措施: Radiotherapy, 28 x 1.8 Gy (Radiation)
Induction CT, chemoradiotherapy
Induction chemotherapy with gemcitabine or FOLFIRINOX; Radiotherapy, 28 x 1.8 Gy; Chemotherapy, gemcitabine;
干预措施: Chemotherapy, gemcitabine (Drug)
Induction CT, chemotherapy
Induction chemotherapy with gemcitabine or FOLFIRINOX; Chemotherapy with gemcitabine or FOLFIRINOX according to induction chemotherapy
干预措施: Induction chemotherapy with gemcitabine or FOLFIRINOX (Drug)
Induction CT, chemotherapy
Induction chemotherapy with gemcitabine or FOLFIRINOX; Chemotherapy with gemcitabine or FOLFIRINOX according to induction chemotherapy
干预措施: Chemotherapy with gemcitabine or FOLFIRINOX according to induction chemotherapy (Drug)
结局指标
主要结局
Overall survival
时间窗: Participants will be followed for the duration of therapy and for 5 years after the last study treatment
次要结局
- rate of local recurrence or local progression(Participants will be followed for the duration of therapy and for 5 years after the last study treatment)
- Rate of curative resections (R0) after chemotherapy and chemoradiotherapy(Participants will be followed for the duration of therapy and for 5 years after the last study treatment)
- Tumor-free survival(Participants will be followed for the duration of therapy and for 5 years after the last study treatment)
- Rate of remission(Participants will be followed for the duration of therapy and for 5 years after the last study treatment)
- Rate of distant metastasis(Participants will be followed for the duration of therapy and for 5 years after the last study treatment)
- Acute and late toxicity of the chemoradiotherapy(Participants will be followed for the duration of therapy and for 5 years after the last study treatment)
- Changes in Quality of life(Participants will be followed for the duration of therapy and for 5 years after the last study treatment)