Colorectal CancerNCT00689364
Comprehensive Therapy to Relieving the Risk of Recurrence and Metastasis for Colorectal Cancer
An observational study of Colorectal Cancer, run by Ministry of Science and Technology of the People´s Republic of China at 1 site in China.
Trial summary
Comprehensive therapy of traditional Chinese medicine (CTTCM) could relieve risk of recurrence and metastasis for stage II \& III colorectal cancer, the investigators take this clinical trial with retrospective-prospective cohort study based on previous studies by international multi-center way. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer
- How many people
- 480 participants
- Where
- 1 siteChina
- Study dates
- Apr 2007to Mar 2014
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: CTTCT plus CWMT cohort in China:160 CWMT cohort in China:160 CWMT cohort in Norway:300
Who may be able to join
- Patient who is diagnosed colorectal cancer by patho\& cytologic diagnosis since accepting radical operation within half a year.
- Stage II or III colorectal cancer.
- 18-75 yr.
- Being able to participate and sign the informed consent.
Who cannot join
- Pregnant woman, Psychotic.
- Patient who put together with other cancer.
- Existed serious complaint and functional disturbance (impairment) with non-tumorous in arch-organ.
- Reactiveness cerebrovascular disease (CVD) .
- Uncontrolled infection and metabolic disease.
- One item of tumor marks is progressed, and it still is progressed when patient recheck.
- Tumor that it is neo-occurred in each organ or pelvic cavity or abdominal cavity without definite patho-quality.
Trial locations and contacts
1 site in 1 country.
China1 site
Xi-Yuan Hospital, China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, 100091
About this study
Official title: Retrospective-Prospective Cohort Study Effectiveness of Comprehensive Therapy of TCM to Relieving the Risk of Recurrence and Metastasis for Stage II & III Colorectal Cancer Based on Conventional Western Medicine Therapy
Comprehensive therapy of traditional Chinese medicine (CTTCM) could relieve risk of recurrence and metastasis for stage II \& III colorectal cancer, the investigators take this clinical trial with retrospective-prospective cohort study based on previous studies by international multi-center way.
If the study shows a positive result, a pragmatic randomized controlled study with prospective, multi-centre and large-sample design will be given continuously. The aim is to establish recommended programs suggested by CTTCM strategies under conventional Western medicine therapy (CWMT) for stage II \& III colorectal cancer.
Read the detailed description
CTTCM: taking TCM decoction based on syndrome differentiation daily and each dosage is decocted two times for intervention one year with a Chinese patent medicine at least.
CWMT: with or without chemotherapy/or radiotherapy after the radical operation (R0) (according to the latest NCCN clinical guideline).
- Conditions
- Colorectal Cancer
- Keywords
- Cohort Study, Colorectal Cancer, Traditional Chinese Medicine, Risk of recurrence and metastasis
- Medical subject headings
- Colorectal Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CTTCT+CWMT | CTTCM:taking TCM decoction based on syndrome differentiation daily and each dosage is decocted two times for intervention one year with a Chinese patent medicine at least. CWMT :with or without chemotherapy/or radiotherapy after the radical operation (R0) (according to the latest NCCN clinical guideline). | |
| CWMT cohort | CWMT :with or without chemotherapy/or radiotherapy after the radical operation (R0) (according to the latest NCCN clinical guideline). |
What is being measured
The primary outcome is the main question the study is designed to answer.
The recurrence and metastasis rates for 1、2、3、4 and 5-year.
Measured: one year
Secondary outcomes (1)
Survival index: the survival rate for1、2、3、4 and 5-year.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2008 (estimated)
- Study startApr 2007
- Primary completionMar 2012 (estimated)
- Study completionMar 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ministry of Science and Technology of the People´s Republic of China
- Sponsor type
- Other government
- Collaborators
- National Research Centre of Complementary and Alternative Medicine, Norway
- Investigators
- Yang Yufei, doctor, Study director, Xi-Yuan Hospital, China Academy of Chinese Medical Sciences, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00689364
- Sponsor's protocol ID
- WJB730603
- Status last verified
- Jun 2011
- First submitted
- 27 May 2008
- Last updated
- 22 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective-Prospective Cohort Study Effectiveness of Comprehensive Therapy of TCM to Relieving the Risk of Recurrence and Metastasis for Stage II & III Colorectal Cancer Based on Conventional Western Medicine Therapy
- ClinicalTrials.gov ID
- NCT00689364
- Acronym / sponsor ID
- WJB730603
- Conditions
- Colorectal Cancer
- Keywords
- Cohort Study, Colorectal Cancer, Traditional Chinese Medicine, Risk of recurrence and metastasis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Ministry of Science and Technology of the People´s Republic of ChinaOther government
- Collaborators
- National Research Centre of Complementary and Alternative Medicine, Norway
- Study start
- Apr 2007
- Primary completion
- Mar 2012 (estimated)
- Study completion
- Mar 2014 (estimated)
- First posted
- 3 Jun 2008 (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.
Comprehensive therapy of traditional Chinese medicine (CTTCM) could relieve risk of recurrence and metastasis for stage II \& III colorectal cancer, the investigators take this clinical trial with retrospective-prospective cohort study based on previous studies by international multi-center way.
If the study shows a positive result, a pragmatic randomized controlled study with prospective, multi-centre and large-sample design will be given continuously. The aim is to establish recommended programs suggested by CTTCM strategies under conventional Western medicine therapy (CWMT) for stage II \& III colorectal cancer.
Detailed description
CTTCM: taking TCM decoction based on syndrome differentiation daily and each dosage is decocted two times for intervention one year with a Chinese patent medicine at least.
CWMT: with or without chemotherapy/or radiotherapy after the radical operation (R0) (according to the latest NCCN clinical guideline).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CTTCT+CWMT | – | –CTTCM:taking TCM decoction based on syndrome differentiation daily and each dosage is decocted two times for intervention one year with a Chinese patent medicine at least. CWMT :with or without chemotherapy/or radiotherapy after the radical operation (R0) (according to the latest NCCN clinical guideline). |
| CWMT cohort | – | –CWMT :with or without chemotherapy/or radiotherapy after the radical operation (R0) (according to the latest NCCN clinical guideline). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- CTTCT plus CWMT cohort in China:160 CWMT cohort in China:160 CWMT cohort in Norway:300
Key inclusion criteria (4 listed)
- Patient who is diagnosed colorectal cancer by patho\& cytologic diagnosis since accepting radical operation within half a year.
- Stage II or III colorectal cancer.
- 18-75 yr.
- Being able to participate and sign the informed consent.
Key exclusion criteria (7 listed)
- Pregnant woman, Psychotic.
- Patient who put together with other cancer.
- Existed serious complaint and functional disturbance (impairment) with non-tumorous in arch-organ.
- Reactiveness cerebrovascular disease (CVD) .
- Uncontrolled infection and metabolic disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The recurrence and metastasis rates for 1、2、3、4 and 5-year.
Time frame: one year
1 secondary outcome
Survival index: the survival rate for1、2、3、4 and 5-year.
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2011.
- Related InfoLink provided by the sponsor.
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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.
Yang Yufei, doctor study director
Xi-Yuan Hospital, China Academy of Chinese Medical Sciences, 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 Colorectal Cancer, run by Ministry of Science and Technology of the People´s Republic of China 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 4 inclusion and 7 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 22 Jul 2011. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The recurrence and metastasis rates for 1、2、3、4 and 5-year. (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jul 2011.