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

• Conditions: Advanced Colorectal Cancer; Traditional Chinese Medicine
• Interventions: Other: Traditional Chinese medicine herbals; Other: Western medicine; Other: Integrated traditional Chinese and Western medicine

• Registration Number: NCT02923622
• Lead Sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-09
• Study Start: 2016-09
• Study First Submitted: 2016-09-23
• Study First Submitted QC: 2016-10-01
• Last Update Submitted: 2016-10-01
• Study First Posted: 2016-10-04
• Last Update Posted: 2016-10-04
• Primary Completion: 2020-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 384

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Traditional Chinese medicine group	Traditional Chinese medicine herbals	-
Western medicine group	Western medicine	-
Traditional Chinese and Western medicine combined group	Integrated traditional Chinese and Western medicine	-

Primary Outcome Measures

Name	Time	Method
Overall survival	3 years

Secondary Outcome Measures

Name	Time	Method
Progress free survival	3 years
Quality of life as assessed by FACT-C v4.0	3 years
Tumor control rate	3 years
TCM syndrome score	3 years
Number of participants with treatment-related adverse events as assessed by Chinese version of CTCAE v4.0	3 years

Trial Locations

Locations (1)

Oncology Department of Xiyuan hospital of China Academy of Chinese Medical Sciences; 🇨🇳 Beijing, Beijing, China