First Line Avastin/FOLFIRI in Combination With Curcumin-containing Supplement in Colorectal Cancer Patients With Unresectable Metastasis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 44
- 主要终点
- Progression-free survival
研究概览
简要总结
Oral curcumin-containing supplement will be given to colorectal cancer patients with unresectable metastases who will be starting Avastin/FOLFIRI chemotherapy for up to completion of (or withdrawal from) chemotherapy.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age : 20 Years and older
- •Histologically confirmed adenocarcinoma of the colon or rectum
- •Patients with primary colon or rectal cancer and unresectable metastatic lesions.
- •Patients with no primary cancer related symptoms.
- •ECOG performance status of 0 - 2
- •Appropriate organ functions (hepatic transaminases - less than 5 times the normal range; bilirubin - less than 2 times the normal range; creatinine serum - less than 1.5 times the normal range; thrombocyte - more than 100,000/µl; neutrophil - more than 1,500/µl)
- •ASA score of < 3
- •An informed consent form has been signed by the patient.
排除标准
- •Colorectal cancer other than adenocarcinoma
- •The patient received adjuvant chemotherapy within the past 6 months.
- •The patient received chemotherapy for metastatic colon cancer.
- •The patient was planning to have curative surgery for the metastatic lesions.
- •Patients with peritoneal carcinomatosis.
- •Patients with primary tumor related complications such as intestinal obstruction, intractable bleeding, and perforation, that needs to be treated.
- •ASA score of > 4
- •The patient has chronic hepatitis or cirrhosis. An asymptomatic HBV or HCV carrier can participate.
- •Patients with an active infection, which need antibiotic therapy, during the randomization period.
- •Pregnant or breastfeeding women
- •Patients with another different malignant tumor during the past 5 years. Patients with treated non-melanoma skin cancer or cervical cancer can be enrolled in this study.
研究组 & 干预措施
Avastin/FOLFIRI with curcumin
Patients will receive first line Avastin/FOLFIRI in combination with curcumin-containing supplement
干预措施: Avastin/FOLFIRI (Drug)
Avastin/FOLFIRI with curcumin
Patients will receive first line Avastin/FOLFIRI in combination with curcumin-containing supplement
干预措施: Curcumin (Dietary Supplement)
结局指标
主要结局
Progression-free survival
时间窗: 2 years
The primary end point of this study is to evaluate progression-free survival in colorectal cancer patients with unresectable metastasis after treatment with first line Avastin/FOLFIRI in combination with a dietary supplement of nanostructured lipid curcumin particle (Aju Pharm, Korea), which improved biotransformation and bioavailability profiles of curcumin.
次要结局
- Overall survival rate(3 years)
- Overall response rate(2 years)
- Safety (assessed by toxicity grades defined by NCI-CTCAE (version 4.0)(2 years)
- Quality of life (QoL)(2 years)
- Fatigue (FACIT-Fatigue scale (version 4, Korean version)(2 years)
研究者
Jeong-Heum Baek, MD
Professor
Gachon University Gil Medical Center