A Phase I Study of TS-1 With Concurrent Radiotherapy Followed by Gemcitabine and TS-1 in Metastatic Pancreatic Cancer (SR-GS Study)
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- maximum-tolerated dose
研究概览
简要总结
The purpose of this study is to determine whether combination of TS-1 and concurrent and short-course radiotherapy is feasible in metastatic pancreatic cancer. The rationale of this study primarily bases on the good efficacy of gemcitabine plus TS-1 and the great potential of local control of concurrent chemoradiotherapy in pancreatic cancer.
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, newly diagnosed pancreatic adenocarcinoma or adenosquamous carcinoma
- •no previous radiotherapy, chemotherapy, targeted therapy, curative surgery, or immunotherapy used for pancreatic cancer
- •presence of at least one measurable lesion, which must meet the criteria of being ≥ 20 mm in at least one dimension by conventional CT/MRI or ≥ 10 mm by spiral CT scan
- •age between 20 and 79 years at registration
- •ECOG PS of 0 or 1
- •adequate major organ functions
- •ability to take the oral study medication (TS-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 or significant co-morbid medical conditions
- •moderate or severe ascites or pleural effusion that requires drainage
- •central nervous system metastasis
- •prior or concurrent malignancies within the last 3 years
- •concomitant treatment with flucytosine, phenytoin or warfarin
- •pregnant women or nursing mothers, or positive pregnancy test
- •severe mental disorder
- •judged ineligible by physician for participation in the study due to safety concern
研究组 & 干预措施
S-1-CCRT
There are five dose levels and one arm only. Level 1: S-1, 25 mg/m2, bid, Day 1-14; RT 25 Gy/10 fx, Day 1-5, 8-12 Level 2: S-1, 25 mg/m2, bid, Day 1-14; RT 30 Gy/10 fx, Day 1-5, 8-12 Level 3: S-1, 30 mg/m2, bid, Day 1-14; RT 30 Gy/10 fx, Day 1-5, 8-12 Level 4: S-1, 30 mg/m2, bid, Day 1-16; RT 36 Gy/12 fx, Day 1-5, 8-12, 15-16 Level 5: S-1, 35 mg/m2, bid, Day 1-16; RT 36 Gy/12 fx, Day 1-5, 8-12, 15-16 All dose levels are followed by Gemcitabine/S-1 (G 1000 mg/m2, iv, D1 and 15 plus S-1 60/80/100 mg/day based on BSA, po, D1-7, D15-21, q4w) after the CCRT
干预措施: S-1-CCRT (Drug)
结局指标
主要结局
maximum-tolerated dose
时间窗: 6 weeks
maximum tolerated dose
时间窗: 6 weeks
Dose-limiting toxicities (DLT) are defined as the following manifestations of toxicity observed until completion of CCRT: 1. grade 3 leucopenia and/or neutropenia with a fever ≥ 38°C lasting 3 days or more 2. grade 3 leucopenia and/or neutropenia with infection 3. grade 4 leucopenia and/or neutropenia lasting 3 days or more 4. grade 4 leucopenia and/or neutropenia requiring G-CSF 5. platelet \< 25,000/mm3 6. , grade 3 thrombocytopenia requiring transfusion 7. hemoglobin \< 8.0 g/dL g. serum AST/ALT ≥ 10 times ULN h. total bilirubin ≥ 3 times ULN i. creatinine \>3.0 - 6.0 times ULN (grade 3) i. grade 3 or 4 nonhematological toxicities including nausea, vomiting, anorexia, fatigue, constipation, hyperglycemia, and abnormality of sodium, potassium, and calcium If three or more patients experience DLT at a given dose level, then the previous dose level will be considered as the MTD.
次要结局
未报告次要终点