Prospective Epidemiological Study to Expand Knowledge on Efficacy and Safety of a Routine Post-operative Supportive Therapy With the Mistletoe Extract Iscador® Qu Within Oncological Treatment of Colorectal Cancer Stages UICC II-IV
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 9
- 主要终点
- Disease-free survival time (DFS).
研究概览
简要总结
Efficacy and safety of a supportive treatment with European mistletoe extract Iscador® Qu ("quercus", i.e. from oak tree) in patients with colorectal cancer (Union for International Cancer Control, UICC stages II-IV), in addition to post-operative conventional oncological therapy (radio-, chemo-, targeted therapy) as compared to a parallel group with conventional therapy only.
Primary Endpoints: Reduction of adverse effects of conventional therapy; reduction of therapy or disease induced symptoms (both are quality of life parameters and evaluated after 1 year); prolongation of disease free and/or overall survival (DFS, OS) after 5 years.
Prospective observational confirmation study of previous retrospective cohort study.
As this is a non-interventional cohort study, all therapies and measurements are performed on directive by the treating physician and/or request by the patient only.
详细描述
see summary
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of colorectal cancer, UICC stage II-IV
- •Age between 18 (Austria: 19) and 85 years
- •No previous malign tumor
- •Surgical resection of the tumor if indicated
- •(Post-operative) conventional oncological therapy and measurements, or passive after-care ("best care")
- •Follow-up for several years feasible
- •Patient gives written consent to use the anonymized date for evaluation
排除标准
- •Anal cancer
- •Other Iscador® sorts than Qu in the test group
- •Other mistletoe preparations in the test group
- •Any mistletoe preparation in the control group
- •Non-oncological immunomodulating, -stimulating or -suppressive drugs (e.g. Echinacea, interferons, Polyerga®, BCG, azathioprine). Allowed are approved tumor inhibiting immuno- or targeted therapies (e.g. bevacizumab, cetuximab) and tumor specific vaccines
- •HIV infection, Aids, organ transplantation
- •High-dose systemic glucocorticoids
- •Contraindications for Iscador® Qu (allergy against mistletoe, acute inflammatory disease or fever > 38.5°C, active tuberculosis, hyperthyreosis with not-adjusted metabolism, primary brain or spinal tumor, brain metastases)
- •Known mistletoe intolerance
- •Patients participating in another clinical study with non-approved substances
结局指标
主要结局
Disease-free survival time (DFS).
时间窗: 5 years
次要结局
- Number of patients with at least one therapy or disease induced symptom (surrogate parameter for quality of life)(1 year)
- Mean values of Karnofsky performance status, Eastern Cooperative Oncology Group (ECOG) score(1 year)
- Interim analysis on overall survival time (OS) in UICC stage IV patients(2 years)
- Safety of Iscador® Qu (number of patients with systemic or local adverse events (AE) to Iscador® Qu)(5 years)
- Number of patients with unexpected adverse events (UAE) contributed to conventional oncological therapy (radio-, chemo-, targeted therapy).(1 year)