NCT02923622

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
384

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

September 23, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 4, 2016

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
Last Updated

October 4, 2016

Status Verified

September 1, 2016

Enrollment Period

3.5 years

First QC Date

September 23, 2016

Last Update Submit

October 1, 2016

Conditions

Advanced Colorectal CancerTraditional Chinese Medicine

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    3 years

Secondary Outcomes (5)

  • 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

Study Arms (3)

Traditional Chinese and Western medicine combined group

Other: Integrated traditional Chinese and Western medicine

Traditional Chinese medicine group

Other: Traditional Chinese medicine herbals

Western medicine group

Other: Western medicine

Interventions

Traditional Chinese medicine herbalsOTHER

TCM herbal treatment based on TCM syndrome differentiation，without any anti tumor therapy in Western Medicine

Traditional Chinese medicine group
Integrated traditional Chinese and Western medicineOTHER

TCM herbal treatment combine with anti tumor therapy in Western Medicine ( including non recommended chemotherapy, radiotherapy and targeted therapy in clinical guidelines)

Traditional Chinese and Western medicine combined group
Western medicineOTHER

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

Western medicine group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

the patients with advanced colorectal cancer and the tumor progressed after conventional chemotherapy

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Beijing, Beijing Municipality, 100091, China

Location

Related Publications (1)

  • Hao TT, Xu Y, Cui N, Qu Q, Liang BY, Yuan JH, Zhao Y, Li QN, Lu F, Wu Y. Effectiveness and Safety Evaluation of Chinese Medicine in Treatment of Metastatic Colorectal Cancer after Chemotherapy Failure: Protocol of a Prospective Multicenter Cohort Study. Chin J Integr Med. 2021 Sep;27(9):674-679. doi: 10.1007/s11655-020-3420-0. Epub 2020 Aug 19.

    PMID: 32820453DERIVED

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2016

First Posted

October 4, 2016

Study Start

September 1, 2016

Primary Completion

March 1, 2020

Last Updated

October 4, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)