Advanced Colorectal Cancer, Traditional Chinese Medicine
Conditions
Brief summary
Although patients of colorectal cancer use Traditional Chinese Medicine (TCM) herbal therapy extensively in China, no strong evidence exists to demonstrate the safety and survival outcomes of TCM herbal therapy combined with conventional western medicine for treatment of this disease. The purpose of this multi-center perspective cohort study is to evaluate the relationship between TCM herbal therapy and survival outcomes in patients with advanced colorectal cancer.
Interventions
OTHERTraditional Chinese medicine herbals
TCM herbal treatment based on TCM syndrome differentiation，without any anti tumor therapy in Western Medicine
TCM herbal treatment combine with anti tumor therapy in Western Medicine ( including non recommended chemotherapy, radiotherapy and targeted therapy in clinical guidelines)
OTHERWestern medicine
Anti tumor therapy in Western Medicine ( including non recommended chemotherapy, radiotherapy and targeted therapy in clinical guidelines)
Sponsors
Beijing Municipal Science & Technology Commission
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* histologically confirmed adenocarcinoma of the colon or rectum * TNM classification of stage IV disease according to American Joint Committee on Cancer * Between 18 and 80 years old * Progression or inability undergone conventional chemotherapy (Conventional chemotherapy regimen containing fluorouracil, oxaliplatin, irinotecan based chemotherapy, and all the above regimen should be used before) * Expected survival time is over 3 months * Signed informed consent
Exclusion criteria
* serious non-malignant diseases such as heart, renal, and hepatic illnesses * the presence of other types of malignancies * The patients can not take medicine for intestinal obstruction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | 3 years |
Secondary
| Measure | Time frame |
|---|---|
| TCM syndrome score | 3 years |
| Number of participants with treatment-related adverse events as assessed by Chinese version of CTCAE v4.0 | 3 years |
| Quality of life as assessed by FACT-C v4.0 | 3 years |
| Tumor control rate | 3 years |
| Progress free survival | 3 years |
Countries
China
Outcome results
None listed