Real-world Retrospective Data Analysis of Adjuvant Therapy for Patients With Stage II-III Colon Cancer After Radical Surgery

NCT03958435 | Unknown

• 1 other identifier: REDUCE201809
• Study Type: observational
• Target: 20,000
• Locations: 1 country
• Sites: 3

Brief Summary

Background:

1. 1.. The incidence and mortality of colon cancer are high in China and in the world.
2. 2.. 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.
3. 3.. Current status of adjuvant therapy for stage II-III colon cancer in the real world: chemotherapy regimen, chemotherapy time, efficacy, safety, etc.
4. 4.. 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
5. 5.. 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

Conditions

Stage II Colon Cancer; Stage III Colon Cancer; Adjuvant Therapy

Keywords

Current status; Chemotherapy regimen; Chemotherapy time; Efficacy; Safety; Adjuvant therapy; Stage II-III colon cancer; RWS(Real World Study)

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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

  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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.)

You may qualify if:

• Patients who are sick after January 2010
• Age is older than 18
• Surgical pathology confirmed TNM stage II-III (AJCC 7th edition) colon cancer

You may not qualify if:

• Combine other tumors
• Pathological information is not clear
• Researchers believe that other reasons are not suitable for enrollment

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (3)

Jiangsu Province People Hospital

Nanjing, Jiangsu, China

RECRUITING

Changhai Hospital of Shanghai

Shanghai, Shanghai Municipality, China

RECRUITING

SAHZU

Hangzhou, Zhejinag, 310009, China

RECRUITING

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Central Study Contacts

Ying Yuan, Ph.D&MD

CONTACT

+86-571-87784795; yuanying1999@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 25, 2018
• First Posted: May 22, 2019
• Study Start: November 9, 2018
• Primary Completion: October 15, 2022
• Study Completion: December 15, 2023
• Last Updated: July 15, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share

Locations

CN (3)