A Phase II Study of Induction Chemotherapy Followed by Concurrent Chemotherapy With Radiotherapy in Locally Advanced Pancreatic Cancer
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 45
- 试验地点
- 4
- 主要终点
- The primary end point is to evaluate the local response rate after induction chemotherapy and concurrent chemoradiotherapy in locally advanced pancreatic cancer.
研究概览
简要总结
Induction chemotherapy will be administered every 2 weeks for 6 cycles (about 3 months). Patients who have radiological evidence of progressive disease will be shifted to salvage chemotherapy. Patients who have responsive or stable disease after induction chemotherapy will receive concurrent chemoradiotherapy 3-4 weeks after the last dose of induction chemotherapy. Surgical evaluation will be performed 4-6 weeks after the completion of chemoradiotherapy. Patients who have resectable disease will undergo surgical resection. Postoperative adjuvant chemotherapy with GOFL for 6 cycles will be given for those who have curative resection. Patients who still have unresectable disease or non-curative resection will receive systemic chemotherapy of GOFL till disease progression or unacceptable toxicity.
详细描述
Induction chemotherapy will be administered on a biweekly basis. Reported adverse events and potential risks for gemcitabine, oxaliplatin, 5-FU and leucovorin are described in Section 6. Appropriate dose modifications for are described in Section 5. No investigational or commercial agents or therapies other than those described below may be administered with the intent to treat the patient's malignancy.
4.1.1 Treatment schedule of induction chemotherapy
For each dose of GOFL chemotherapy, intravenous infusion of gemcitabine at a fixed rate of 10 mg/m2/min will be immediately followed by a 2-hour intravenous infusion of oxaliplatin and then a 48-hour intravenous infusion of 5-FU and leucovorin.
4.1.2 Premedication before chemotherapy
Patients will receive 4mg of dexamethasone and anti-histamine and appropriate anti-emetics (serotonin antagonists) before each dose of 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
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients must have histologically or cytologically confirmed adenocarcinoma of pancreas.
- •Patients must have locally advanced pancreatic cancer.
- •Patients must have unresectable pancreatic cancer evaluated by radiologist and/or surgeon according to either abdominal CT or MRI, or intra-operative findings.
- •Locally advanced unresectable disease was defined by CT or MRI images as low-density tumor (primary and/or lymphadenopathy) with
- •extension to the celiac axis or superior mesenteric artery,
- •occlusion of the superior mesenteric-portal venous confluence
- •aortic, inferior vena cava (IVC) invasion or encasement
- •invasion of SMV below transverse mesocolon
- •rib, vertebral invasion
- •Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques or as >10 mm with spiral CT scan. See section 8.2 for the evaluation of measurable disease.
- •Age >20 years. Because no dosing or adverse event data are currently available on the use of study agents in patients <20 years of age, children are excluded from this study.
- •ECOG performance status 0-2; see Appendix A.
- •Patients must have normal organ and marrow function as defined below:
- •absolute neutrophil count >1,500/mL
- •platelets >100,000/mL
- •total bilirubin <3X institutional upper limit of normal
- •ALT(SGPT) <5 X institutional upper limit of normal
- •creatinine within normal institutional limits or creatinine clearance >60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
- •Patients who present with jaundice, temporary or permanent internal / external drainage before enrollment will be allowed.
- •The effects of study agents on the developing human fetus at the recommended therapeutic dose are unknown. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- •Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Patients with distant metastases are not eligible.
- •Patients may not be receiving any other investigational agents.
- •Patients who have had prior chemotherapy or radiotherapy are not eligible.
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agents used in the study.
- •Patients who have above grade II peripheral neuropathy.
- •Patients who had non-curable second primary malignancy.
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- •Pregnant women are excluded from this study because the study agents has the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with study agents, breastfeeding should be discontinued if the mother is treated with the study agents.
- •Because patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with study agent administered during the study. Appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated.
结局指标
主要结局
The primary end point is to evaluate the local response rate after induction chemotherapy and concurrent chemoradiotherapy in locally advanced pancreatic cancer.
chemotherapy and concurrent chemoradiotherapy in locally advanced pancreatic cancer. .
次要结局
- The secondary end points are to evaluate the distant metastasis rate and time to tumor progression, overall survival time and quality of life after induction