Neoadjuvant FOLFOXIRI (Irinotecan, Oxaliplatin and Fluorouracil) Chemotherapy in Patients With Locally Advanced Colon Cancer：an Open-label, Single-arm, Multicenter Phase II Study
试验速览
- 阶段
- 2 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The ratio of tumor downstaging to stage 0 and stage I
研究概览
简要总结
To evaluate the efficacy and safety of neoadjuvant FOLFOXIRI chemotherapy (irinotecan, oxaliplatin and fluorouracil) in the patients with locally advanced colon cancer.
详细描述
For the patients with locally advanced colon cancer, adjuvant FOLFOX and XELOX chemotherapy have become standard treatment. However, 30% - 40% patients suffered from local recurrence or distant metastasis after this standard treatment. Neoadjuvant chemotherapy could shrink tumors, eliminate micrometastasis, reduce surgical trauma and accelerate recovery. Hence, we evaluate the efficacy and safety of FOLFOXIRI as neoadjuvant chemotherapy in treating patients with locally advanced colon cancer.
In this prospective study, 30 patients with locally advanced colon cancer will be treated with 4 cycles of neoadjuvant FOLFOXIRI chemotherapy followed by surgical resection. PET-CT scanning will be performed before and after the neoadjuvant FOLFOXIRI chemotherapy to assess SUVmax changes. The ctDNA in peripheral blood before and after each cycle of neoadjuvant FOLFOXIRI chemotherapy will be detected. In the course of treatment, safety evaluation will be carried out according to adverse reaction classification (CTCAE) 4. 0.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Previous treatment with oxaliplatin, irinotecan or fluorouracil
- •Hypersensitivity to fluorouracil, oxaliplatin or irinotecan.
- •With distant metastasis
- •Cardiovascular disease that would preclude study treatment or follow-up; New York Heart Association class III or IV heart disease; active ischemic heart disease; myocardial infarction within the past 6 months; symptomatic arrhythmia uncontrolled hypertension. Unexplained syncope occurred within 3 months
- •Digestive system diseases that would preclude study treatment or follow-up within the past 6 months
- •Gastric ulcers or duodenal ulcers for the treatment of resistance;
- •3 or 4 grade gastrointestinal bleeding / bleeding;
- •Gastrointestinal perforation / fistula;
- •abdominal abscess;
- •Infectious or inflammatory bowel disease
- •HIV infection and/or active hepatitis B virus infection
- •Pregnant or lactating women. Fertile patients must use effective contraception
- •Any serious acute or chronic disease that can not be involved in the study or to influence the interpretation of the results of the study
- •Other intervention clinical trials were combined at the same time.
- •Nerve or mental abnormality affecting cognitive ability
- •Other malignancy except effectively treated squamous cell or basal cell skin cancer,
- •Other situations that the researchers think should be excluded
研究组 & 干预措施
FOLFOXIRI
Patients received 4 cycles of neoadjuvant FOLFOXIRI chemotherapy before surgical resection.
干预措施: FOLFOXIRI (Drug)
结局指标
主要结局
The ratio of tumor downstaging to stage 0 and stage I
时间窗: 2 years
Tumor downstaging from stage II or III to pathologic complete response (stage 0) and stage I
次要结局
- Disease free survival(3 years)
- Quality of life (QLQ C30)(Every 2 weeks after the first treatment until 3 years)
- Overall survival time(3 years)
- Tumor regression grade (TRG)(2 years)
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability](3 years)
- ctDNA change(3 years)
- SUVmax changes(At the begin of Cycle 1 and the end of Cycle 4 (each cycle is 14 days))
研究者
Jingdong Zhang
Director
China Medical University, China