Clinical trial NCT05316818: Triplet (FOLFOXIRI) vs. Doublet (FOLFOX or FOLFIRI) Regimen as a 1st Line Treatment in Metastatic Colorectal Carcinoma
Official title: The Efficacy and Toxicity of Triplet Regimen (FOLFOXIRI) Versus Doublet Regimen (FOLFOX or FOLFIRI) as First Line Treatment in Locally Advanced, Recurrent or Metastatic Colorectal Carcinoma.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Colorectal Cancer
Keywords: First line chemotherapy
FOLFOXIRI
standard doublet
Efficacy
Toxicity
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2022-04-07
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 the first line for treatment of metastatic colorectal carcinoma by adding third agent to standard doublet regimen on oncological outcomes \& assess tolerance to the intensified treatment

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 receive FOLFOXIRI (experimental arm) or FOLFIRI or FOLFOX4 (control arm) biweekly up to 12 cycles.

Randomization was done by enclosed envelope method Evaluation of the patients for surgical resection of residual metastases was done every 12 weeks. In the case of secondary resection of metastases, patients completed with the same chemotherapy regimen received before resection up to 12 cycles Maintenance therapy with capecitabine for 6 months was administered for patients who achieved complete or partial tumor response. In case of disease progression, second line chemotherapy was then administered in both groups until tumor progression, the occurrence of an unacceptable adverse event, or patient refusal

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Overall response rate (ORR)
timeFrame: 6 months ( from staring treatment till finishing 12 cycles, each cycle every 2 weeks)
measure: Rate of adverse events
timeFrame: During the study treatment period till 30 days following the end of therapy
Secondary outcomes:
measure: Progression free survival (PFS)
timeFrame: 18 months
measure: Overall survival time (OS)
timeFrame: 18 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr El AiniH
state: El Manial
Study officials:
References: