NCT01941641进行中（未招募）2 期
A Phase II Study of Neoadjuvant FOLFOXIRI Followed by Concurrent Capecitabine and Radiotherapy for High Risk Rectal Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Objective tumour response rate
研究概览
简要总结
Objective tumour response rate to FOLFOXIRI to pre-operative therapy.
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
- •Age >= 18 years of either sex.
- •ECOG performance status 0-1
- •Measurable disease by RECIST 1.1 criteria.
- •Histologically confirmed rectal adenocarcinoma (defined as either mid- or low rectal cancer that is located within 12 cm from the anal verge OR below the peritoneal reflection) that is previously untreated.
- •'High risk' rectal cancer, or rectal cancers that are considered marginally operable where there is a significant risk of positive surgical margin:
- •T3 (low-lying tumour at or below the levators) or T4, or
- •Tumour infiltrating perirectal fat, or
- •Any T-stage (T1-4) and node-positive tumour (invading surrounding structures or peritoneum)
- •Adequate bone marrow, renal and hepatic function as defined by: absolute neutrophil count >= 1.5 x 109/L, hemoglobin >= 9 g/L, platelets >= 100 x 109/L, calculated creatinine clearance >= 55 ml/min, total bilirubin =<1.5 x the upper limit of normal, alanine aminotransferase (ALT) =<2.5 upper limit of normal.
排除标准
- •Known distant metastasis, even if the metastasis has been resected.
- •History of another invasive malignancy within the last 5 years, except for treated basal cell carcinoma of the skin, cervical intraepithelial neoplasia, or non-invasive DCIS of the breast.
- •Upper rectal cancer that is located above the peritoneal reflection.
- •Primary tumour associated with any one of the following features:
- •Frank intestinal obstruction, or
- •Endoscope unable to pass through the tumour's lumen plus worsening local obstructive symptoms. Note: Patients with such features should be assessed by the surgical team regarding stomal bypass prior to study enrolment. Such patients can still be considered for study enrolment after undergoing stomal bypass.
- •Known hypersensitivity reaction to the study drugs (i.e. fluoropyrimidine, irinotecan, oxaliplatin)
- •Known peripheral neuropathy of grade 2 or more in severity.
- •Patients who have received an experimental anticancer therapy within the last 28 days.
- •Previous pelvic radiotherapy. Previous oxaliplatin or irinotecan for the treatment of colon or rectal cancer
- •Patient with hip prosthesis
- •Major surgery within the last 28 days. Exception: Any patient who underwent stomal bypass for obstructing primary tumour within the last 14 days are still eligible, as long as the patient has sufficiently recovered from the surgery at the investigator's discretion.
研究组 & 干预措施
neoadjuvant FOLFOXIRI
Experimental
干预措施: neoadjuvant FOLFOXIRI (Drug)
neoadjuvant FOLFOXIRI
Experimental
干预措施: Capecitabine (Drug)
结局指标
主要结局
Objective tumour response rate
时间窗: 2 years
次要结局
- Number of Participants with Adverse Events(2 years)
- Tumour regression grade(2 years)
- Rate of tumour downstaging(2 years)
- disease-free survival, relapse-free survival(5 years)
- Time to local (and distant) recurrence(5 years)
- pathologic complete response(2 years)
- Compliance to study treatment(2 years)
- Number of response to neoadjuvant therapy(2 years)
- Overall survival(5 years)
- Number of patients with 30-day post-operative mortality(1 month)
- Rate of circumferential resection margin (CRM) clearance(2 years)
研究者
CCTU
Comprehensive Cancer Trials Unit
Chinese University of Hong Kong
研究点 (1)
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