Neoadjuvant mFOLFOXIRI Chemotherapy Alone for Extramural Vascular Invasion(EMVI) Positive Rectal Cancer: A Phase II, Single-arm, Prospective Clinical Study
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- MFS
研究概览
简要总结
Extramural Vascular Invasion Positive(EMVI+) is a high risk of distant metastasis for locally advanced rectal cancer(LARC) after resection. The study is to evaluate the efficacy and safety of mFOLFOXIRI as neoadjuvant chemotherapy alone for EMVI+ LARC.
详细描述
It is an investigator-initiated, single institution, prospective, single-arm clinical study to evaluate the efficacy and safety of FOLFOXIRI as neoadjuvant chemotherapy alone for EMVI+ LARC.Patients of LARC with EMVI+ evaluated by pelvic magnetic resonance imaging (MRI) were enrolled in this trial. All EMVI+ LARC will receive the study regimen every 2 weeks for 6 cycles. MRI will be performed after 3 cycles of chemotherapy to assess clinical response.MRI was performed to assess clinical response after chemotherapy. Patients with mesorectal fascia-positive or ycT4a/b after re-evaluation would receive radiation before surgery, whereas responders would have immediate total mesorectal excision (TME).If the tumor response is good enough(partial response or complete response), the patient will receive another 3 cycles of FOLFOXIRI then surgery. On the contrary, if the tumor shows poor response(stable disease or progressive disease) or with mesorectal fascia-positive or ycT4a/b after re-evaluation, radiotherapy will be performed combined with capecitabine before operation. All patients will receive 6 cycles of mFOLFOX6 or 4 cycles XELOX as adjuvant chemotherapy after TME.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥ 18 to 75 years at diagnosis;
- •ECOG status 0 or 1;
- •Signed informed consent; able to comply with study and/or follow- up procedures;
- •Diagnosis of rectal adenocarcinoma;
- •Distal border of the tumor must be located < 12 cm from the anal verge;
- •MRI examination diagnosed EMVI-positive;
- •Tumor amenable to curative resection;
- •Adequate bone marrow, hepatic and renal function as assessed by the following laboratory requirements conducted within 7 days of starting study treatment: (1) Neutrophilic granulocytes ≥ 3.0 x10^9/L, Platelet count ≥ 75 x 10^9/L, Hemoglobin (Hb) ≥ 90g/L; (2) bilirubin ≤1.5 x the upper limit of normal (ULN),Alanine aminotransferase (ALT)/Aspartate aminotransferase (AST) ≤ 2.5 x ULN; (3) Serum creatinine ≤ 1.5 x ULN.
- •No renal disease that would preclude study treatment or follow-up
排除标准
- •Hypersensitivity to fluorouracil, oxaliplatin or irinotecan;
- •Patient had received pelvic radiotherapy;
- •Patient had received systemic chemotherapy;
- •History of invasive colon or rectal malignancy, regardless of disease-free interval;
- •Had metastatic disease;
- •Patient had second malignant disease within 5 years;
- •Uncontrolled co-morbid illnesses or other concurrent disease;
- •Patients refused to signed informed consent.
- •Pregnant and Nursing women;
研究组 & 干预措施
mFOLFOXIRI
patients received FOLFOXIRI alone for 6 cycles before surgery.
干预措施: mFOLFOXIRI (Drug)
结局指标
主要结局
MFS
时间窗: Three years
metastasis free survival
次要结局
- Reported Adverse events(2 years)
- Tumor downstaging rate(2 years)
- DFS(3 years)
- OS(5 years)
- pCR(2 years)
- R0 rate(2 years)
- locoregional recurrence(3 years)
研究者
Hanju Hua
Associate chief physician
First Affiliated Hospital of Zhejiang University