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

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Xiyuan Hospital of China Academy of Chinese Medical Sciences

Status

Unknown

Conditions

Traditional Chinese Medicine
Advanced Colorectal Cancer

Treatments

Other: Integrated traditional Chinese and Western medicine
Other: Traditional Chinese medicine herbals
Other: Western medicine

Study type

Observational

Funder types

Other

Identifiers

NCT02923622
D161100005116002

Details and patient eligibility

About

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.

Enrollment

384 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

384 participants in 3 patient groups

Traditional Chinese and Western medicine combined group
Treatment:
Other: Integrated traditional Chinese and Western medicine
Traditional Chinese medicine group
Treatment:
Other: Traditional Chinese medicine herbals
Western medicine group
Treatment:
Other: Western medicine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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