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

Advanced Colorectal Cancer Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02923622
• Other study ID #: D161100005116002
• Status: Not yet recruiting
• Phase: N/A
• First received: September 23, 2016
• Last updated: October 1, 2016
• Start date: September 2016

Study information

• Verified date: September 2016
• Source: Xiyuan Hospital of China Academy of Chinese Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Beijing Municipal Science and Technology Commission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 384
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Advanced Colorectal Cancer
• Colorectal Neoplasms
• Traditional Chinese Medicine

Intervention

Other:
• Traditional Chinese medicine herbals
TCM herbal treatment based on TCM syndrome differentiation,without any anti tumor therapy in Western Medicine
• Integrated traditional Chinese and 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 medicine
Anti tumor therapy in Western Medicine ( including non recommended chemotherapy, radiotherapy and targeted therapy in clinical guidelines)

Locations

Country	Name	City	State
China	Oncology Department of Xiyuan hospital of China Academy of Chinese Medical Sciences	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Xiyuan Hospital of China Academy of Chinese Medical Sciences	Beijing Municipal Science & Technology Commission

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		3 years	Yes
Secondary	Progress free survival		3 years	Yes
Secondary	Quality of life as assessed by FACT-C v4.0		3 years	Yes
Secondary	Tumor control rate		3 years	Yes
Secondary	TCM syndrome score		3 years	Yes
Secondary	Number of participants with treatment-related adverse events as assessed by Chinese version of CTCAE v4.0		3 years	Yes