Efficacy and Safety Evaluation of Traditional Chinese Medicine in the Treatment of Advanced Colorectal Cancer

Xiyuan Hospital of China Academy of Chinese Medical Sciences384 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

384

Conditions

Advanced Colorectal Cancer Traditional Chinese Medicine

Interventions

Traditional Chinese medicine herbalsOTHER

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)

Western medicineOTHER

Anti tumor therapy in Western Medicine ( including non recommended chemotherapy, radiotherapy and targeted therapy in clinical guidelines)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Oncology Department of Xiyuan hospital of China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

Overall survival

Time frame: 3 years

Secondary Outcomes

Progress free survival

Time frame: 3 years

Quality of life as assessed by FACT-C v4.0

Time frame: 3 years

Tumor control rate

Time frame: 3 years

TCM syndrome score

Time frame: 3 years

Number of participants with treatment-related adverse events as assessed by Chinese version of CTCAE v4.0

Time frame: 3 years

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.