The Purpose of This Study is to Evaluate the Effectiveness of MB-6 as Adjuvant Therapy in Reducing Neutropenia When Given Oxaliplatin-based Chemotherapy in Patients With Stage 3 Colorectal Cancer Previously Treated With Surgery.
试验速览
- 阶段
- 不适用
- 入组人数
- 184
- 试验地点
- 1
- 主要终点
- The primary endpoint is the incidence of grade 4 neutropenia during the chemotherapy period, defined as an absolute neutrophil count (ANC) <500/mm3.
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled multi-center phaseⅢstudy to evaluate efficacy and safety of oxaliplatin-based chemotherapy plus MB-6(320 mg/capsule, 6 capsules tid) in patients with stage 3 colorectal cancer who underwent surgical excision of their primary tumor.
详细描述
The investigational new drug, MB-6, in the proposed clinical trial is to be used as an adjuvant therapy for metastatic colorectal cancer patients. All of six extracts have been used in human with a long history, and many literatures reported the medicinal use either individually or as ingredients of formulations. MB-6 may provide its therapeutic benefits via inhibition of tumor induction or enhancing the efficacy of chemotherapy in colorectal cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women 20 years of age or older.
- •Histologically or cytologically confirmed stage 3 colorectal adenocarcinoma.
- •Complete resection of the primary tumor without gross or microscopic evidence of residual disease.
- •No more than 8 weeks have elapsed from the time of surgery and have recovered from the effects.
- •Eastern Cooperative Oncology Group Performance Status (ECOG PS) < 2 at the time of screening.
- •Hematological function: ANC≥1500/mm3, Hemoglobin ≥9.0 g/dL, Platelet count ≥100000/mm
- •Kidney function:Serum creatinine <2 mg/dL.
- •Liver function: AST ≤3 times ULN, ALT ≤3 times ULN, Total Bilirubin ≤2 times ULN.
- •Ability to understand and the willingness to sign a written informed consent document according to institutional guidelines.
- •Men and women of childbearing potential must agree to employ adequate contraception during the study period.
排除标准
- •History of second primary malignancies except for adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix.
- •Systemic chemotherapy, immune therapy or experimental or approved antibodies/proteins (e.g. bevacizumab) administered after surgery and prior to randomization.
- •Concurrent treatment with any other anticancer therapy.
- •Radiotherapy ≤14 days prior to randomization.
- •Any unresolved toxicity > CTC (Common Toxicity Criteria) grade 1 from previous anti-cancer therapy (including radiotherapy) except haematological toxicity and alopecia.
- •Patients with congestive heart failure, epilepsy, or other significant medical conditions as judged by the investigator.
- •Contraindications to FOLFOX chemotherapy: peripheral neuropathy NCI CTC >1, liver failure, uncontrolled coronary heart disease, myocardial infarction within the previous 6 months before randomization.
- •Patient of child-bearing potential is evidently pregnant or is breast feeding.
研究组 & 干预措施
MB-6+FOLFOX chemotherapy
MB-6, 6 capsules tid be taken with meals plus FOLFOX chemotherapy, will be given for 18 weeks
干预措施: MB-6 (Drug)
Placebo+FOLFOX chemotherapy
Placebo, 6 capsules tid be taken with meals plus FOLFOX chemotherapy, will be given for 18 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
The primary endpoint is the incidence of grade 4 neutropenia during the chemotherapy period, defined as an absolute neutrophil count (ANC) <500/mm3.
时间窗: 18 weeks
The primary endpoint is the incidence of grade 4 neutropenia during the chemotherapy, defined as an absolute neutrophil count (ANC)\<500/mm3
次要结局
- Health-Related Quality of Life (HRQoL) - QLQ-C30(18 weeks)
- Quality of Life -VAS on Fatigue, Constipation, Appetite(18 weeks)
- Time to first Grade 4 Neutropenia(18 weeks)
- Incidence of Febrile Neutropenia(18 weeks)
- Incidence of Grade 3 or 4 Neutropenia(18 weeks)
- Increase in Body Weight(18 weeks)
- Change in Serum Creatinine level(18 weeks)
- Compliance with Chemotherapy(18 weeks)