NCT01237665Unknown2 期
A Phase II Trial of Neoadjuvant IXO Regimen (Irinotecan, Capecitabine [Xeloda], Oxaliplatin) Followed by Combined Modality Capecitabine and Radiation for Locally Resectable Advanced Rectal Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Pathological complete response (pCR)
研究概览
简要总结
This is a prospective open label single-arm, single-institution phase II clinical trial to test the efficacy of neoadjuvant treatment with IXO (Irinotecan, Capecitabine [Xeloda], Oxaliplatin) followed by chemoradiotherapy and resection in patients with resectable non-metastatic primary rectal cancer of stage cT3-T4 N0-N2.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically confirmed rectal adenocarcinoma
- •T3 or T4 or N1 (node ≥1 cm on short axis) adenocarcinoma of the rectum.
- •ECOG performance status equal or less than 1
- •Male and female patients, aged ≥ 18 years and ≤ 80 years
- •Written informed consent
- •Adequate haematological, liver, renal function
- •Resectability
- •Patients categorized as having resectable locally advanced cancer
- •Favorable general condition
排除标准
- •Resectability
- •Diagnosis of metastatic disease
- •Clear indication of involvement of pelvic wall(s), on imaging.
- •Peritoneal carcinomatosis, portal vein occlusion, ascites, non-regional lymph nodes
- •Histology other than adenocarcinoma
- •Obstructed rectal carcinoma without defunctionalizing colostomy
- •Prior treatment
- •Previously undergone treatment for this disease
- •Prior chemotherapy for colorectal cancer
- •Prior chemotherapy for other malignancies in past 12 months
- •Prior radiotherapy other than skin cancer
- •Concomitant use of St John's Wort
- •Treatment with any other investigational agent
- •Current use of full-dose of warfarin for therapeutic
- •Other conditions
- •Confirmed or suspected brain metastases
- •History or evidence of CNS disease
- •Past or current history of other malignancies
- •Clinically significant cardiovascular disease
- •Evidence of bleeding diathesis or coagulopathy
- •Known hypersensitivity to any of the study drugs
- •Serious, non-healing wound, ulcer or bone fracture
- •Major surgical procedure or significant traumatic injury within 28 days prior to treatment
- •Disease or condition that contraindicates the use of an investigational drug
- •Life expectancy less than 5 years
- •Inability or unwillingness to comply with the protocol
- •Neuropathy ≥ Gr.2
- •History of ulcerative colitis or Crohn's disease
- •Pelvic abscess or perforated pelvic carcinoma
- •Pregnancy / Contraception
- •Pregnancy or lactation
- •Positive serum pregnancy test within 7 days of starting study treatment
研究组 & 干预措施
IXO regimen
Experimental
single-group
干预措施: IXO regimen (Drug)
结局指标
主要结局
Pathological complete response (pCR)
时间窗: 26 weeks
To test the efficacy of neoadjuvant treatment with IXO followed by chemoradiotherapy and surgical resection, evaluated as histological therapy-induced tumour regression, assessed by the rate of pathological complete response (pCR) at the primary tumor site (pT0)
次要结局
- Objective Response(12 weeks and 18 weeks)
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability(every 3 weeks during neoadjuvant chemotherapy; before CRT; 3rd week of CRT; 2 days, 3 weeks and 6 weeks post CRT; pre-op; 2 days and 4 weeks post-op)
- Recurrence(q6 months)
- RFS, PFS, TTR(q6 months)
- Quality of life(enrolment, 12 weeks, 18 weeks, 26 weeks)
- Surgical morbidity and mortality(26 weeks)
- Rate of post-operative sphincter preservation(26 weeks)
- OS(q6 months first 2 years and annually thereafter)
研究者
研究点 (1)
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