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出境医 / 临床实验 / Real-world Retrospective Data Analysis of Adjuvant Therapy for Patients With Stage II-III Colon Cancer After Radical Surgery
Real-world Retrospective Data Analysis of Adjuvant Therapy for Patients With Stage II-III Colon Cancer After Radical Surgery
Study Description
Brief Summary:
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
| Condition or disease |
|---|
| Stage II Colon Cancer Stage III Colon Cancer Adjuvant Therapy |
Study Design
| Study Type : | Observational |
| Estimated Enrollment : | 20000 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Retrospective |
| Official Title: | Real-world Retrospective Data Analysis of Adjuvant Therapy for Patients With Stage II-III Colon Cancer After Radical Surgery |
| Actual Study Start Date : | November 9, 2018 |
| Estimated Primary Completion Date : | October 15, 2019 |
| Estimated Study Completion Date : | December 15, 2019 |
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
- 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
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
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.)
Criteria
Inclusion Criteria:
- Patients who are sick after January 2010
- Age is older than 18
- Surgical pathology confirmed TNM stage II-III (AJCC 7th edition) colon cancer
Exclusion Criteria:
- Combine other tumors
- Pathological information is not clear
- Researchers believe that other reasons are not suitable for enrollment
Contacts and Locations
Contacts
| Contact: Ying Yuan, Ph.D&MD | +86-571-87784795 | yuanying1999@zju.edu.cn |
Locations
| China, Zhejinag | |
| SAHZU | Recruiting |
| Hangzhou, Zhejinag, China, 310009 | |
| Contact: Ying Yuan, Ph.D & MD yuanying1999@zju.edu.cn | |
| Contact: Ying Yuan yuanying1999@zju.edu.cn | |
Sponsors and Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | December 25, 2018 | ||||
| First Posted Date | May 22, 2019 | ||||
| Last Update Posted Date | May 22, 2019 | ||||
| Actual Study Start Date | November 9, 2018 | ||||
| Estimated Primary Completion Date | October 15, 2019 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
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| Original Primary Outcome Measures | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures | Not Provided | ||||
| Original Secondary Outcome Measures | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Real-world Retrospective Data Analysis of Adjuvant Therapy for Patients With Stage II-III Colon Cancer After Radical Surgery | ||||
| Official Title | Real-world Retrospective Data Analysis of Adjuvant Therapy for Patients With Stage II-III Colon Cancer After Radical Surgery | ||||
| Brief Summary |
Background:
The purpose of research:
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| Detailed Description | Not Provided | ||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Case-Only Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| 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：
|
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| Condition |
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| Intervention | Not Provided | ||||
| Study Groups/Cohorts | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Unknown status | ||||
| Estimated Enrollment |
20000 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Estimated Study Completion Date | December 15, 2019 | ||||
| Estimated Primary Completion Date | October 15, 2019 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | China | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03958435 | ||||
| Other Study ID Numbers | REDUCE201809 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Second Affiliated Hospital, School of Medicine, Zhejiang University | ||||
| Study Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University | ||||
| Collaborators | Not Provided | ||||
| Investigators | Not Provided | ||||
| PRS Account | Second Affiliated Hospital, School of Medicine, Zhejiang University | ||||
| Verification Date | May 2019 | ||||