Stage II Colon CancerNCT03958435
Real-world Retrospective Data Analysis of Adjuvant Therapy for Patients With Stage II-III Colon Cancer After Radical Surgery
An observational study of Stage II Colon Cancer and Stage III Colon Cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 3 sites in China.
Trial summary
Background: 1. . The incidence and mortality of colon cancer are high in China and in the world. 2. . The treatment of many patients in the real world is not standardized, and there are problems such as over-treatment or under-treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage II Colon Cancer, Stage III Colon Cancer, Adjuvant Therapy
- How many people
- 20,000 participants
- Where
- 3 sitesChina
- Study dates
- 9 Nov 2018to 15 Dec 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 20000 patients diagnosed with stage II-III colon cancer and undergo radical surgery since January 2010. The demographic analysis of this study will include but limited in： * Demographic characteristics (age, gender, height, weight), * Clinical information (Site, TNM(Tumor, regional lymph Node, Metastasis) staging, CEA(Carcinoembryonic Antigen), imaging findings, patient ECOG(Eastern Cooperative Oncology Group)score, PS(Performance Status) score), * Pathology information (MMR(Mismatch Repair) status, RAS status, BRAF status, HER2 status, Lymph node, Number of detections, Nerve infiltration, Vascular invasion, Histological type, etc.)
Who may be able to join
- Patients who are sick after January 2010
- Age is older than 18
- Surgical pathology confirmed TNM stage II-III (AJCC 7th edition) colon cancer
Who cannot join
- Combine other tumors
- Pathological information is not clear
- Researchers believe that other reasons are not suitable for enrollment
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Recruiting
SAHZU
Hangzhou, Zhejinag, 310009
Ying Yuan, Ph.D & MD, yuanying1999@zju.edu.cn
Ying Yuan, yuanying1999@zju.edu.cn
- Recruiting
Jiangsu Province People Hospital
Nanjing, Jiangsu
Yanhong Gu, MD
- Recruiting
Changhai Hospital of Shanghai
Shanghai, Shanghai Municipality
Wei Zhang, MD
About this study
Background:
- . The incidence and mortality of colon cancer are high in China and in the world.
- . The treatment of many patients in the real world is not standardized, and there are problems such as over-treatment or under-treatment. To explore the adjuvant treatment of colon cancer in the Chinese population, this study will retrospectively analyze real-world data on adjuvant therapy for colon cancer in Chinese patients after radical surgery.
Read more
The purpose of research:
- . Current status of adjuvant therapy for stage II-III colon cancer in the real world: chemotherapy regimen, chemotherapy time, efficacy, safety, etc.
- . Comparison of efficacy and safety of different adjuvant chemotherapy time (<3 months vs. >=3 months) in high-risk stage II and III colon cancer patients in the real world
- . Comparison of efficacy and safety of different adjuvant chemotherapy regimens (XELOX vs. FOLFOX) in high-risk stage II and III colon cancer patients in the real world
- Keywords
- Current status, Chemotherapy regimen, Chemotherapy time, Efficacy, Safety, Adjuvant therapy, Stage II-III colon cancer, RWS(Real World Study)
- Medical subject headings
- Colonic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with chemotherapy regimen for adjuvant therapy after stage II and stage III colon cancer
Percentage of patients with chemotherapy regimen for adjuvant therapy after stage II and stage III colon cancer
Measured: From patients after stage II and stage III colon cancer radical resection to until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months.
Percentage of patients with different chemotherapy time for adjuvant therapy for stage II and stage III colon cancer
Percentage of patients with different chemotherapy time for adjuvant therapy for stage II and stage III colon cancer
Measured: From patients after stage II and stage III colon cancer radical resection to until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months.
Percentage of Participants with treatment-related Adverse Events as Assessed by CTCAE v4.0 for adjuvant therapy for stage II and stage III colon cancer
Percentage of Participants with treatment-related Adverse Events as Assessed by CTCAE v4.0 for adjuvant therapy for stage II and stage III colon cancer
Measured: From patients after stage II and stage III colon cancer radical resection to until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2019
- Study start9 Nov 2018
- Primary completion15 Oct 2022 (estimated)
- Study completion15 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage II Colon CancerStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 20,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03958435
- Sponsor's protocol ID
- REDUCE201809
- Status last verified
- May 2021
- First submitted
- 25 Dec 2018
- Last updated
- 15 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Retrospective Data Analysis of Adjuvant Therapy for Patients With Stage II-III Colon Cancer After Radical Surgery
- ClinicalTrials.gov ID
- NCT03958435
- Acronym / sponsor ID
- REDUCE201809
- Keywords
- Current status, Chemotherapy regimen, Chemotherapy time, Efficacy, Safety, Adjuvant therapy, Stage II-III colon cancer, RWS(Real World Study)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 9 Nov 2018 (actual)
- Primary completion
- 15 Oct 2022 (estimated)
- Study completion
- 15 Dec 2023 (estimated)
- First posted
- 22 May 2019 (actual)
- 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.
Background:
- . The incidence and mortality of colon cancer are high in China and in the world.
- . The treatment of many patients in the real world is not standardized, and there are problems such as over-treatment or under-treatment. To explore the adjuvant treatment of colon cancer in the Chinese population, this study will retrospectively analyze real-world data on adjuvant therapy for colon cancer in Chinese patients after radical surgery.
The purpose of research:
- . Current status of adjuvant therapy for stage II-III colon cancer in the real world: chemotherapy regimen, chemotherapy time, efficacy, safety, etc.
- . Comparison of efficacy and safety of different adjuvant chemotherapy time (<3 months vs. >=3 months) in high-risk stage II and III colon cancer patients in the real world
- . Comparison of efficacy and safety of different adjuvant chemotherapy regimens (XELOX vs. FOLFOX) in high-risk stage II and III colon cancer patients in the real world
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 20000 patients diagnosed with stage II-III colon cancer and undergo radical surgery since January 2010. The demographic analysis of this study will include but limited in： * Demographic characteristics (age, gender, height, weight), * Clinical information (Site, TNM(Tumor, regional lymph Node, Metastasis) staging, CEA(Carcinoembryonic Antigen), imaging findings, patient ECOG(Eastern Cooperative Oncology Group)score, PS(Performance Status) score), * Pathology information (MMR(Mismatch Repair) status, RAS status, BRAF status, HER2 status, Lymph node, Number of detections, Nerve infiltration, Vascular invasion, Histological type, etc.)
Key inclusion criteria (3 listed)
- Patients who are sick after January 2010
- Age is older than 18
- Surgical pathology confirmed TNM stage II-III (AJCC 7th edition) colon cancer
Key exclusion criteria (3 listed)
- Combine other tumors
- Pathological information is not clear
- Researchers believe that other reasons are not suitable for enrollment
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
Percentage of patients with chemotherapy regimen for adjuvant therapy after stage II and stage III colon cancer
Time frame: From patients after stage II and stage III colon cancer radical resection to until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months.
Percentage of patients with chemotherapy regimen for adjuvant therapy after stage II and stage III colon cancer
Percentage of patients with different chemotherapy time for adjuvant therapy for stage II and stage III colon cancer
Time frame: From patients after stage II and stage III colon cancer radical resection to until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months.
Percentage of patients with different chemotherapy time for adjuvant therapy for stage II and stage III colon cancer
Percentage of Participants with treatment-related Adverse Events as Assessed by CTCAE v4.0 for adjuvant therapy for stage II and stage III colon cancer
Time frame: From patients after stage II and stage III colon cancer radical resection to until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months.
Percentage of Participants with treatment-related Adverse Events as Assessed by CTCAE v4.0 for adjuvant therapy for stage II and stage III colon cancer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2021.
- Individual participant dataSharing planned: Yes
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stage II Colon Cancer and Stage III Colon Cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 3 sites 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 3 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 15 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Contact Ying Yuan, Ph.D&MD (+86-571-87784795, yuanying1999@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with chemotherapy regimen for adjuvant therapy after stage II and stage III colon cancer (time frame: From patients after stage II and stage III colon cancer radical resection to until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months.). The study lists 3 primary outcomes in all. 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 15 Jul 2021; AzTrials last refreshed its copy on 7 Nov 2026.