Re-Play: Impact of FOLFIRINOX Chemotherapy in IV Colorectal Cancer Patients Previously Exposed to Irinotecan, Fluoropyrimidine and Oxaliplatin
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Assess response rate after 4 cycles of FOLFIRINOX
研究概览
简要总结
The purpose of this work is to verify prospectively what the rate of response after triple chemotherapy with mFOLFIRINOX in patients in IV stage of Colorectal Cancer who have already failed after at least two lines of dual combinations with fluoropyrimidine, oxaliplatin, irinotecan and anti-EGFR if wild-type RAS.
Currently at ICESP, patients are frequently re-exposed in third line to double combinations.
详细描述
Single-arm phase II study. The chemotherapy regimen with mFOLFIRINOX will be administered every 14 for 4 cycles, after evaluation of tumor response, you can maintain treatment until disease progression.
The FOLFIRINOX regimen, as well as the drugs used (oxaliplatin, 5-Fluorouracil, leucovorin and irinotecan) is already indicated in the package insert for the treatment of colorectal cancer.
If treatment is discontinued after cycle 4 with the patient responding, for response maximum or unmanageable toxicity, it is suggested to maintain imaging control every 60 days (7-day window) until disease progression. This interval is already commonly used for patients with metastatic disease who are on treatment pause. Treatment in progression of illness will be at the discretion of the treating physician. Cancer patients undergoing chemotherapy routinely perform evaluation of organ functions and CEA, as well as clinical evaluation before each cycle of treatment
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of metastatic colon/rectal adenocarcinoma, with measurable by RECIST v. 1.1
- •Disease progression to at least two lines of chemotherapy with chemotherapy regimens that contain fluoropyrimidine, irinotecan and oxaliplatin
- •Patients with RAS research in tumor sample with result wild animals must have previously received anti-EFGR therapy.
- •ECOG (Eastern Cooperative Oncology Group) 0 or 1
- •Availability of tumor material for molecular analysis
- •Hb > 8, neutrophils > 1,500 and PLQ > 100,000
- •Adequate kidney and liver function
排除标准
- •Active neoplasm with other primary site, except in situ tumors
- •Contraindication to treatment with fluoropyrimidine, oxaliplatin and irinotecan, including previous unmanageable G3 or greater toxicities, in previous exhibitions.
- •Presence of comorbidities that, according to the investigator's assessment, may compromise participant safety
- •Prior exposure to the FOLFIRINOX regimen
- •Pregnant or lactating women
- •Total bilirubin above 1.5mg/dL
- •Hepatic transaminases greater than 3 times the upper limit of normality
研究组 & 干预措施
mFolfirinox
干预措施: mFOLFIRINOX (Drug)
结局指标
主要结局
Assess response rate after 4 cycles of FOLFIRINOX
时间窗: 2 years
次要结局
- Overall Survival(2 years)
- Progression-free survival(2 years)