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The clinical research about Joint detection of toxicity and efficacy related marker of chemotherapy drug in individual therapy of colorectal cancer

The clinical research about Joint detection of toxicity and efficacy related marker of chemotherapy drug in individual therapy of colorectal cancer

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-ONC-13004542
Enrollment
Unknown
Registered
2013-12-05
Start date
2012-06-04
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

case series:FOLFIRI??

Sponsors

Sichuan Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Advanced colorectal cancer confirmed by histology and cytology diagnosis; 2. At least one measurable objective tumor lesions, its largest diameter should be 1 cm or greater under spiral CT examination or PET - CT; its largest diameter should be 2 cm or greater under ordinary CT or MRI; 3. Expected life time for at least 12 weeks; 4. Aged 18 years old or above; 5. ECOG physical state of 0-2; 6. Has stopped chemotherapy or radiotherapy 3 weeks before involved into the group and has recovered from toxic effects of previous treatment.Patients received drugs with delayed toxicity (such as mitomycin or nitrourea) should stop treatment for 6 weeks; 7. Granular leukocytes=1.5×10^9/L, platelet>80×10^9/L; 8. Serum bilirubin should be =1.5 times of upper limits of normal (ULN); 9. ASTALT=2.5 times of upper limits of normal(=5times of ULN in patients with hepatic metastases); 10. Serum creatinine=1.5 times of upper limits of normal (ULN); 11. To be able to compliance research and follow-up procedures; 12. For all possible pregnant women,must do a pregnancy test within 72 hours before starting treatment and the results should be negative; 13. Signed informed consent to participate in this clinical trial.

Exclusion criteria

Exclusion criteria: 1. Any instable systemic diseases(including gastrointestinal ulcers, active infection, four levels of high blood pressure, unstable angina pectoris, congestive heart failure, liver, kidney, metabolic disease, or fracture, the wound has not healed); 2. With any other malignant tumours within 5 years(excluding completely cured cervical carcinoma in situ or basal cell or squamous cell skin cancer); 3. Systemic infection, infective wounds in delay no more; 4. Bone metastases as the only outcome; 5. Pregnant or lactating women; 6. Specifications specified contraindications for irinotecan and fluorouracil; 7. Known to be allergic to irinotecan and fluorouracil.

Design outcomes

Primary

MeasureTime frame
safety;Time to progression;

Secondary

MeasureTime frame
Objective response rate;one-year survival rate;

Countries

China

Contacts

Public ContactJingrui Yu

Sichuan Cancer Hospital

dysgirl2000@sina.com+86 13551237583

Outcome results

None listed

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