ISRCTN58705307已完成1 期
A phase I/IIa study combining curcumin (Curcumin C3 Complex, Sabinsa) with standard care FOLFOX chemotherapy in patients with inoperable colorectal cancer
niversity of Leicester (UK)0 个研究点目标入组 28 人开始时间: 2011年10月28日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 28
研究概览
简要总结
2015 protocol in https://www.ncbi.nlm.nih.gov/pubmed/25872567 2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31132111 (added 04/09/2019)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Histological or cytological diagnosis of metastatic colorectal cancer
- •2. Measurable disease by Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1)
- •3. Adequate haematological, hepatic and renal function
- •4. Age more than or equal to 18 years
- •5. Eastern Cooperative Oncology Group (ECOG) Performance status 0 or 1
- •6. Patients must have recovered from effects of any recent major surgery
- •7. Willing to use contraception if applicable
- •8. Informed consent
- •9. Life expectancy estimated to be more than 12 weeks; Target Gender: Male & Female ; Lower Age Limit 18 no age limit or unit specified
排除标准
- •1.Contraindications to FOLFOX chemotherapy: Peripheral neuropathy National Cancer Institute Common Toxicity Criteria (NCI CTC) >1, Liver failure, uncontrolled coronary heart disease, myocardial infarction within the previous 6 months.
- •2. Unwilling or unable to comply with the study protocol
- •3. Patients who are pregnant or lactating or contemplating pregnancy. Patients or their partners who become pregnant during the study will be referred to the appropriate experts.
- •4. Undergone chemotherapy (other than adjuvant for CRC) or participating in another drug study.
- •5. Previous cancer <5 years (other than colorectal, basal cell carcinoma, in-situ cervical cancer)
- •6. Major surgery within 4 weeks of starting the study
- •7. Co-existing active infection or serious concurrent medical condition
- •8. Significant cardiovascular disease
- •9. Bone metastases
- •10. Known brain or leptomeningeal metastases
- •11. Surgery or hospital admissions for symptomatic intra-abdominal adhesions
- •12. Active endoscopically proven peptic ulcer disease or colitis
研究者
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