A Phase II Study of S-1, Irinotecan, and Oxaliplatin in Locally-Advanced Pancreatic Cancer (SIROX Study) - Followed by Curative Surgery and Adjuvant Chemotherapy
试验速览
- 阶段
- 2 期
- 入组人数
- 35
- 主要终点
- resection rate
研究概览
简要总结
This phase II clinical trial will enroll patients with newly-diagnosed locally-advanced pancreatic adenocarcinoma and adopt the Simon's two-stage optimum design. After 4 cycles of SIROX regimen, patients will proceed to curative resection.
详细描述
This phase II clinical trial will enroll patients with newly-diagnosed locally-advanced pancreatic adenocarcinoma and adopt the Simon's two-stage optimum design. After 4 cycles of SIROX regimen, patients will proceed to curative resection. The primary endpoint of this study is resection rate after neoadjuvant chemotherapy. The first stage will enroll 18 patients. We will go into the second stage if at least 2 patients in stage I become resectable after treatment. There will be at most 35 patients enrolled. Based on this trial, we anticipate that the SIROX regimen has comparable response rate and resection rate but lower toxicities comparing to FOLFIRINOX.
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
- 20 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •histologically or cytologically proven pancreatic adenocarcinoma
- •newly diagnosed, unresectable, locally-advanced pancreatic cancer
- •no potential of R0 resection at diagnosis
- •presence of measurable pancreatic lesion, which must meet the criteria of being ≥ 10 mm in at least one dimension by conventional CT/MRI
- •age between 20 and 79 years at registration
- •ECOG performance status (PS) of 0 or 1
- •adequate major organ functions
- •ability to take the oral study medication (S-1)
- •no clinically significant abnormal ECG findings within 28 days (4 weeks) prior to registration
- •voluntarily signed the written informed consent form
排除标准
- •pulmonary fibrosis or interstitial pneumonitis diagnosed within 28 days prior to registration
- •presence of diarrhea ≥ CTCAE v.4.03 grade 2
- •concomitant active infection
- •significant co-morbid medical conditions, including, but not limited to , heart failure, renal failure, hepatic failure, hemorrhagic peptic ulcer, mechanical or paralytic ileus, or poorly controlled diabetes
- •moderate or severe ascites or pleural effusion that requires drainage
- •prior or concurrent malignancies within the last 3 years, with the exception of carcinoma in situ of the cervix, or basal type skin cancer
- •concomitant treatment with flucytosine, phenytoin or warfarin
- •peripheral neuropathy grade of 2 or higher
- •known Gilbert syndrome or homozygosity for UGT1A1 promoter TA repeats prone to high risk of drug toxicity (screening of UGT1A1 genotype will NOT performed routinely before study)
- •pregnant women or nursing mothers, or positive pregnancy test for women of childbearing potential. Patients of childbearing age should have effective contraception for both the patient and his or her partners during the study period
- •severe mental disorder
- •judged ineligible by physician for participation in the study due to safety concern
研究组 & 干预措施
SIROX
Tegafur-gimeracil-oteracil potassium, irinotecan, oxaliplatin combination
干预措施: Tegafur-gimeracil-oteracil potassium (Drug)
SIROX
Tegafur-gimeracil-oteracil potassium, irinotecan, oxaliplatin combination
干预措施: Oxaliplatin (Drug)
SIROX
Tegafur-gimeracil-oteracil potassium, irinotecan, oxaliplatin combination
干预措施: Irinotecan (Drug)
结局指标
主要结局
resection rate
时间窗: 3 years
patients with R0 or R1 resection of the primary tumor after study chemotherapy/patients receiving at least one dose of study chemotherapy
次要结局
- response rate (RR)(3 years)
- Overall survival (OS)(4 years)