Advanced Colorectal CancerNCT02923622
Efficacy and Safety Evaluation of Traditional Chinese Medicine in the Treatment of Advanced Colorectal Cancer
An observational study of Advanced Colorectal Cancer and Traditional Chinese Medicine, run by Xiyuan Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Advanced Colorectal Cancer, Traditional Chinese Medicine
- What is being tested?
- Traditional Chinese medicine herbals, Integrated traditional Chinese and Western medicine and Western medicine
- How many people
- 384 participants
- Where
- 1 siteChina
- Study dates
- Sep 2016to Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: the patients with advanced colorectal cancer and the tumor progressed after conventional chemotherapy
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site
Oncology Department of Xiyuan hospital of China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, 100091
Yun Xu, M.D., 86 10 62835355, xyxiao78@163.com
Yu Wu, M.D., 86 10 62835438, wy713@vip.sina.com
About this study
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.
- Being tested
- Traditional Chinese medicine herbals, Integrated traditional Chinese and Western medicine, Western medicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional Chinese medicine herbalsOther
TCM herbal treatment based on TCM syndrome differentiation，without any anti tumor therapy in Western Medicine
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)
Western medicineOther
Anti tumor therapy in Western Medicine ( including non recommended chemotherapy, radiotherapy and targeted therapy in clinical guidelines)
| Study group | Role | What they receive |
|---|---|---|
| Traditional Chinese and Western medicine combined group | Not described Receives: Other: Integrated traditional Chinese and Western medicine | |
| Traditional Chinese medicine group | Not described Receives: Other: Traditional Chinese medicine herbals | |
| Western medicine group | Not described Receives: Other: Western medicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: 3 years
Secondary outcomes (5)
Progress free survival
Measured: 3 years
Quality of life as assessed by FACT-C v4.0
Measured: 3 years
Tumor control rate
Measured: 3 years
TCM syndrome score
Measured: 3 years
Number of participants with treatment-related adverse events as assessed by Chinese version of CTCAE v4.0
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2016 (estimated)
- Study startSep 2016
- Primary completionMar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 384 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiyuan Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Municipal Science & Technology Commission
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02923622
- Sponsor's protocol ID
- D161100005116002
- Status last verified
- Sep 2016
- First submitted
- 23 Sep 2016
- Last updated
- 4 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 32820453
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Evaluation of Traditional Chinese Medicine in the Treatment of Advanced Colorectal Cancer
- ClinicalTrials.gov ID
- NCT02923622
- Acronym / sponsor ID
- D161100005116002
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 384 participants (estimated)
- Lead sponsor
- Xiyuan Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Collaborators
- Beijing Municipal Science & Technology Commission
- Study start
- Sep 2016
- Primary completion
- Mar 2020 (estimated)
- First posted
- 4 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- the patients with advanced colorectal cancer and the tumor progressed after conventional chemotherapy
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Traditional Chinese medicine herbalsTCM herbal treatment based on TCM syndrome differentiation，without any anti tumor therapy in Western Medicine | Other | Traditional Chinese medicine group |
| Integrated traditional Chinese and Western medicineTCM herbal treatment combine with anti tumor therapy in Western Medicine ( including non recommended chemotherapy, radiotherapy and targeted therapy in clinical guidelines) | Other | Traditional Chinese and Western medicine combined group |
| Western medicineAnti tumor therapy in Western Medicine ( including non recommended chemotherapy, radiotherapy and targeted therapy in clinical guidelines) | Other | Western medicine group |
Primary outcome
Overall survival
Time frame: 3 years
5 secondary outcomes
Progress free survival
Time frame: 3 years
Quality of life as assessed by FACT-C v4.0
Time frame: 3 years
Tumor control rate
Time frame: 3 years
TCM syndrome score
Time frame: 3 years
Number of participants with treatment-related adverse events as assessed by Chinese version of CTCAE v4.0
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2016.
- Derived from this study: PubMed 32820453Hao 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oncology Department of Xiyuan hospital of China Academy of Chinese Medical Sciences
Beijing, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Colorectal Cancer and Traditional Chinese Medicine, run by Xiyuan Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02923622, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2016.