Induction Chemotherapy With FOLFIRINOX ( 5 Fluorouracil, Oxaliplatine and Irinotecan) Followed by Short Course Radiotherapy in Locally Advanced Rectal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Pathologic complete response
研究概览
简要总结
A Single-arm phase II trial evaluating induction chemotherapy with FOLFIRINOXm followed by short course radiotherapy (RT) in locally advanced rectal carcinoma
详细描述
Total neoadjuvant treatment (TNT) is currently the standard of care in the management of locally advanced rectal cancer since recent studies have shown improved pathological complete response and disease-free survival with this approach. However, survival benefits remain unproven.
Two strategies of TNT are validated so far : induction chemotherapy with FOLFIRINOX followed by long course radio-chemotherapy (RCT) or short course RT (5x5 Gy) followed by consolidation chemotherapy with CAPOX (capecitabine and oxaliplatin) or FOLFOX (5 FU and oxaliplatin) .
The objective of investigators is to evaluate pathological complete response with a new strategy of TNT consisting in induction chemotherapy with FOLFIRINOXm followed by short course RT and a delayed surgery.
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
- •World Health Organization (WHO) performance status : 0 or 1
- •Histologically proven rectal adenocarcinoma < 10 cm from anal margin on rectoscopy
- •clinically T3 (cT3) or clinically T4 (cT4) and/ or N+ non metastatic rectal cancer
- •Neutrophil count > 1500 e/mm3
- •Platelet count >100000
- •Hemoglobin > 10 g/dl ( transfusion allowed)
- •Normal bilirubin level
- •Creatinine clearance > 50 ml/mn
排除标准
- •Distant metastases
- •History of chemotherapy or radiotherapy
- •Grade 1 neuropathy
- •Patient undergoing treatment for another cancer
- •Active infection or severe comorbidities contraindicating chemotherapy
研究组 & 干预措施
Induction CT followed by short course RT
Induction chemotherapy with modified 5 fluorouracil, oxaliplatin and irinotecan followed by short course radiotherapy ( 5x5 Gy), then 5 fluorouracil and oxaliplatin based chemotherapy. Surgery will be performed 6 to 8 weeks after completion of RT.
干预措施: Chemotherapy With FOLFIRINOX ( 5 Fluorouracil, Oxaliplatine and Irinotecan) (Drug)
Induction CT followed by short course RT
Induction chemotherapy with modified 5 fluorouracil, oxaliplatin and irinotecan followed by short course radiotherapy ( 5x5 Gy), then 5 fluorouracil and oxaliplatin based chemotherapy. Surgery will be performed 6 to 8 weeks after completion of RT.
干预措施: Radiotherapy (Radiation)
结局指标
主要结局
Pathologic complete response
时间窗: 1 month after surgery
no tumor identified in the rectum or associated lymph nodes by final pathology following surgical resection
次要结局
- Disease free survival(3 years)
- overall survival(3 years)
- objective response rate to induction chemotherapy(immediately after completion of 6 cycles of chemotherapy ( each cycle is 14 days))
研究者
Amel Mezlini
Professor in Medical Oncology
Salah Azaïz Cancer Institute