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A prospective study of precision treatment for pT1 stage colon cancer based on genotyping

A study of precise treatment model for pT1 stage colon cancer based on genotyping

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000036349
Enrollment
Unknown
Registered
2020-08-22
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colon cancer

Interventions

Group A:Radical surgery+Targeted drugs
Group B:Local excision

Sponsors

Fudan University Shanghai Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged >=18 years old; 2. Pathologically confirmed pT1 colon cancer patients; 3. ECOG performance status of 0 to 2; 4. ASA score of 1 to 2; 5. Adequate bone marrow, liver and renal function to receive chemotherapy and subsequently to undergo surgery: (1) white blood cells >3,000/uL, absolute neutrophil count >=1,500/UL, platelets >=100,000/uL, hemoglobin >=9 g/dL; (2) serum creatinine =60 mL/min according to Cockroft-Gault formula or to local lab measurement; (3) serum bilirubin <1.25 UNL, AST(SGOT) and ALT(SGPT) <2.5 UNL; 6. Comply with the study protocol and follow-up; 7. Written informed consent.

Exclusion criteria

Exclusion criteria: 1. Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ; 2. Any other concurrent medical conditions contraindicating surgery or chemotherapy that could compromise the adherence to the protocol; 3. Other conditions, such as religious, psychological and other factors, that could interfere with provision of informed consent, compliance to study procedures, or follow-up.

Design outcomes

Primary

MeasureTime frame
AE;SAE;Overall Survival;Progression-Free Survival;

Countries

China

Contacts

Public ContactDawei Li

Fudan University Shanghai Cancer Center

davidleehero@126.com+86 13774201693

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026