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Effectiveness and Safety Evaluation of Chinese Medicine in Treatment of Metastatic Colorectal Cancer after Chemotherapy Failure: Protocol of a Prospective Multicenter Cohort Study
- Source :
- Chinese Journal of Integrative Medicine. 27:674-679
- Publication Year :
- 2020
- Publisher :
- Springer Science and Business Media LLC, 2020.
-
Abstract
- Background Colorectal cancer (CRC) is the second most common cause of cancer-related deaths and has the third highest incidence in the world. Almost half of the patients with CRC have metastases at the time of diagnosis. However, the treatment for patients with metastatic CRC that progresses after approved conventional chemotherapy is still controversial. Chinese medicine (CM) has unique characteristics and advantages in treating metastatic CRC. Objective To assess the effectiveness and safety of CM in patients with metastatic CRC after failure of conventional chemotherapy. Methods The study is a multicenter prospective cohort study. A total of 384 patients with documented metastatic CRC after failure of conventional chemotherapy will be included from 9 hospitals among Beijing, Shanghai, Nanjing, and Guizhou, and assigned to three groups according to paitents' wishes: (1) integrated Chinese and Western medicine (ICM) group receiving CM herbal treatment combined with Western medicine (WM) anti-tumor therapy, (2) Chinese medicine (CM) group receiving only CM herbal treatment, and (3) WM group receiving only WM anti-tumor therapy. The primary endpoint is the overall survival (OS). Secondary endpoints include the progression free survival (PFS), quality of life (QOL) assessed by the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) questionnaire, tumor control, and CM symptom score. Discussion This prospective study will assess the effectiveness and safety of CM in treating metastatic CRC after conventional chemotherapy failure. Patients in the ICM group will be compared with those in the WM group and CM group. If certified to be effective, national provision of CM treatment in metastatic CRC will probably be advised. (Registration No. NCT02923622 on ClinicalTrials.gov).
- Subjects :
- China
medicine.medical_specialty
Colorectal cancer
0211 other engineering and technologies
02 engineering and technology
Traditional Chinese medicine
030226 pharmacology & pharmacy
03 medical and health sciences
0302 clinical medicine
Quality of life
Internal medicine
Antineoplastic Combined Chemotherapy Protocols
021105 building & construction
medicine
Clinical endpoint
Humans
Pharmacology (medical)
Prospective Studies
Treatment Failure
Progression-free survival
Medicine, Chinese Traditional
Prospective cohort study
business.industry
Cancer
General Medicine
medicine.disease
Complementary and alternative medicine
Quality of Life
Colorectal Neoplasms
business
Cohort study
Subjects
Details
- ISSN :
- 19930402 and 16720415
- Volume :
- 27
- Database :
- OpenAIRE
- Journal :
- Chinese Journal of Integrative Medicine
- Accession number :
- edsair.doi.dedup.....ad7f56ce85c08b4364a87666121b81bb