NCT03792269Unknown2 期
An Open-label, Randomized, Phase II Clinical Trial Comparing the Efficacy and Safety of Intraperitoneal and System Chemotherapy Versus XELOX as First-line Chemotherapy for Metastatic Colorectal Cancer
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年1月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Progression-free Survival (PFS)
研究概览
简要总结
XELOX as first-line treatment regimen has limited efficacy against patients with metastatic colorectal cancer (mCRC). Peritoneal metastasis is one of the most lethal factor for mCRC. Intraperitoneal chemotherapy has became a widely accepted strategy in the treatment of peritoneal dissemination. We hypothesized that combined multi-channel administration, such as intraperitoneal chemotherapy, oral chemotherapy, and intravenous chemotherapy, can produce better results than XELOX for first-line treatment for mCRC patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Patients must have histologically confirmed adenocarcinoma of clorectal with inoperable locally advanced or metastatic disease, not amenable to curative therapy.
- •Patients must have measurable disease, according to the Response Evaluation Criteria in Solid Tumors (RECIST, v1.1), assessed using imaging techniques (CT or MRI).
- •Women of childbearing potential must be non-pregnant (negative pregnancy test within 72 hours prior to chemotherapy, postmenopausal woman must have been amenorrheic for at least 12 months to be considered of non-childbearing potential) and nonlactating, and men and women must be willing to exercise an effective form of birth control (abstinence/contraception) while on study and for 6 months after therapy completed Eastern Cooperative Oncology Group (ECOG) Performance status 0, 1 or
- •Absolute neutrophil count (ANC) >=1,500/ul Platelets (PLT) >=75,000/ul Serum bilirubin <= 1.5 × upper limit of normal (ULN) Aspartate transaminase (AST) or alanine aminotransferase (ALT) <= 2.5 × ULN (or <= 5 × ULN in patients with liver metastases) Alkaline phosphatase <= 2.5 × ULN (or <= 5 × ULN in patients with liver metastases, or <= 10 × ULN in patients with bone but no liver metastases) Albumin >= 25 g/L. Creatinine clearance >= 60 mL/min. Life expectancy of at least 3 months. Signed informed consent.
排除标准
- •Previous chemotherapy for advanced/metastatic disease (prior adjuvant/neoadjuvant therapy is allowed if at least 6 months has elapsed between completion of adjuvant/neoadjuvant therapy and enrolment into the study).
- •Patients with active (significant or uncontrolled) gastrointestinal bleeding. Residual relevant toxicity resulting from previous therapy (with the exception of alopecia), e.g. neurological toxicity ≥ grade 2 NCI-CTCAE 4.
- •Other malignancy within the last 5 years, except for carcinoma in situ of the cervix, or basal cell carcinoma.
- •History of documented congestive heart failure; angina pectoris requiring medication;evidence of transmural myocardial infarction on ECG; poorly controlled hypertension (systolic BP > 180 mmHg or diastolic BP > 100 mmHg); clinically significant valvular heart disease; or high risk uncontrollable arrhythmias.
- •Baseline left ventricular ejection fraction (LVEF) < 50% (measured by echocardiography or MUGA).
- •Patients with dyspnoea at rest due to complications of advanced malignancy or other disease, or who require supportive oxygen therapy.
- •Patients receiving chronic or high dose corticosteroid therapy. (Inhaled steroids and short courses of oral steroids for anti-emesis or as an appetite stimulant are allowed).
- •Clinically significant hearing abnormality. Known dihydropyrimidine dehydrogenase (DPD) deficiency. History or clinical evidence of brain metastases. Serious uncontrolled systemic intercurrent illness, e.g. infections or poorly controlled diabetes.
- •Positive serum pregnancy test in women of childbearing potential. Received any investigational drug treatment within 4 weeks of start of study treatment.
- •Radiotherapy within 4 weeks of start of study treatment (2 week interval allowed if palliative radiotherapy given to bone metastatic site peripherally and patient recovered from any acute toxicity;prior adjuvant radiotherapy is allowed if complete at least 6 months ).
- •Major surgery within 4 weeks of start of study treatment, without complete recovery.
- •Patients with known active infection with HIV, hepatitis B virus (HBV), or hepatitis C virus (HCV).
- •Known hypersensitivity to any of the study drugs.
研究组 & 干预措施
Multi-channel chemotherapy
Experimental
Patients will receive intraperitoneal irinotecan (50mg, d1, q2w).
干预措施: Irinotecan (Drug)
Control Group
Active Comparator
Patients will receive intravenous oxaliplatin (130mg/m^2, d1, q3w), and oral capecitabine (1.0g, d1-14, q3w).
干预措施: Oxaliplatin (Drug)
Control Group
Active Comparator
Patients will receive intravenous oxaliplatin (130mg/m^2, d1, q3w), and oral capecitabine (1.0g, d1-14, q3w).
干预措施: Capecitabine (Drug)
结局指标
主要结局
Progression-free Survival (PFS)
时间窗: up to 1 year
PFS is the period between the first course of treatment to disease recurrence. The follow-up work will be performed every 6 weeks until disease recurrence or loss to follow-up.
次要结局
- Objective Response Rate (ORR)(up to 24 weeks)
- Adverse Events (AE)(up to 2 years)
- Overall Survival (OS)(up to 2 years)
研究者
Jing Hu
investigator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
研究点 (1)
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