Status:
COMPLETED
Triplet (FOLFOXIRI) vs. Doublet (FOLFOX or FOLFIRI) Regimen as a 1st Line Treatment in Metastatic Colorectal Carcinoma
Lead Sponsor:
Kasr El Aini Hospital
Conditions:
Metastatic Colorectal Cancer
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief Summary
This is a prospective randomized phase II trial was done in clinical oncology department at Kasr Alainy hospital, Cairo university (NEMROCK) to evaluate the role of intensification of chemotherapy in ...
Detailed Description
Patients with histologically proven adenocarcinoma of the colon or rectum, with unresectable measurable metastatic disease, were enrolled and randomized in a 1:1 ratio. Patients were assigned to rece...
Eligibility Criteria
Inclusion
- Patients with histologically proven adenocarcinoma of the colon or rectum, with unresectable measurable metastatic disease
- No previous treatment for the metastatic disease was allowed, only previously fluoropyrimidine-based adjuvant chemotherapy was allowed if ended more than 6 months before enrollment in the study
- Adequate haematological parameters (leukocyte count of at least 3,500/mm₃, neutrophil count of at least 1,500/ mm and platelet count of at least 100,000/mm
- Adequate liver and renal function parameters (serum creatinine ≤ 1.3 mg/dL, serum bilirubin ≤ 1.5 mg/dL and AST, ALT and alkaline phosphatase 2.5 x upper normal values or less.
- Patient had no co-morbidity disease
Exclusion
- Poor performance status 3-4 according to ECOG score, prior chemotherapy for advanced, recurrent or metastatic disease, other simultaneous malignancies and pregnant or lactating female
Key Trial Info
Start Date :
January 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 10 2021
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT05316818
Start Date
January 16 2018
End Date
April 10 2021
Last Update
April 7 2022
Active Locations (1)
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1
Kasr El AiniH
Cairo, El Manial, Egypt, 11555