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Selection of gene to predict disease or guide prognosis in advanded/relapsed colorectal cancer with FOLFIRI as first-line therapy

Selection of gene to predict disease or guide prognosis in advanded/relapsed colorectal cancer with FOLFIRI as first-line therapy

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-TNC-11001535
Enrollment
Unknown
Registered
2011-07-28
Start date
2011-08-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

colorectal cancer

Interventions

Total:CPT-11, 5-Fu

Sponsors

Henan cancer hospital affiliated to Zhengzhou university
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. colorectal cancer was histologically confirmed; 2. aged between 18 to 70years; 3. Disease evaluated according to RESCIST standard, the size >=1cm in CT/MRI or the size >=2cm by physical examination; 4. locally advanced (no operation or not totally resection R1/R2) colotectal cancer; metastatic or relapsed colorectal cancer; 5. FOLFIRI as first-line therapy, an anti-cancer targeting durg (such as cetuximab and (Bevacizumab) permitted and the palliative radiotherapy besides pelvis permitted; 6. no pregnant; 7. KPS>=60% or ECOG <=2; 8. written informed consent; 9. impared liver and renal function rectified to standard level.

Exclusion criteria

Exclusion criteria: 1. total bilirubin more than 3 times upper limit; creatinine more than 1.5 times upper limit; AST or ALT more than 2. 5 times upper limit without liver metastasis; AST or ALT more than 5 times upper limit with liver metastasis; 2. symptomatic brain metastasis; 3. severe marrow failure not rectified; 4. psychosis not easily controlled; 5. pregnant or lactation; 6. secondary cancer; 7. severe systemic disease: unstable angina, myocardial infarction, severe brain hemorrhage or cerbral infarction within 3 months; 8. chronic enteritis and CPT-11 not suitable to use; 9. bowel obstruction.

Design outcomes

Primary

MeasureTime frame
SNP associated with the effects/side effects of CPT-11, 5-Fu;diarrhea neutropenia cytopenia (III/IV) TTF;TIP30 promoter methylation;ORR;

Secondary

MeasureTime frame
SNP associated with prognose;

Countries

China

Contacts

Public ContactLuo Suxia
luosxrm@163.com+86 371 65587783

Outcome results

None listed

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