Clinical trial NCT03958435: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
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)
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2019-05-22
Enrollment: 20000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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.)

Brief 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. 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:

1. . Current status of adjuvant therapy for stage II-III colon cancer in the real world: chemotherapy regimen, chemotherapy time, efficacy, safety, etc.
2. . 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
3. . 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


Eligibility 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

Primary outcomes:
measure: Percentage of patients with chemotherapy regimen for adjuvant therapy after stage II and stage III colon cancer
timeFrame: 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.
measure: Percentage of patients with different chemotherapy time for adjuvant therapy for stage II and stage III colon cancer
timeFrame: 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.
measure: 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
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jiangsu Province People Hospital
state: Jiangsu
city: Shanghai
country: China
facility: Changhai Hospital of Shanghai
state: Shanghai
city: Hangzhou
country: China
facility: SAHZU
state: Zhejinag
Study officials:
References: