Triplet (FOLFOXIRI) vs. Doublet (FOLFOX or FOLFIRI) Regimen as a 1st Line Treatment in Metastatic Colorectal Carcinoma

Metastatic Colorectal Cancer Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05316818
• Other study ID #: I-160317
• Status: Completed
• Phase: Phase 2
• Start date: January 16, 2018
• Est. completion date: April 10, 2021

Study information

• Verified date: March 2022
• Source: Kasr El Aini Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: April 10, 2021
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Intervention

Drug:
• FOLFOXIRI Protocol
Triplet chemotherapy regimen consists from active three cytotoxic agents aiming to improve outcomes

Locations

Country	Name	City	State
Egypt	Kasr El AiniH	Cairo	El Manial

Sponsors (1)

Lead Sponsor	Collaborator
Kasr El Aini Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate (ORR)	the percentage of patients, relative to the total of enrolled subjects, achieving a complete (CR) or partial (PR) response, according to RECIST 1.1 criteria	6 months ( from staring treatment till finishing 12 cycles, each cycle every 2 weeks)
Primary	Rate of adverse events	Adverse events (haematological & non-haematological) were assessed before each cycle using the Common Terminology Criteria for Adverse Events version (CTCAE) 5.0, 2017 with scale from (G0-5) for each event.	During the study treatment period till 30 days following the end of therapy
Secondary	Progression free survival (PFS)	the time from randomization to the first documentation of objective disease progression or death due to any cause, whichever occurs first. Documentation of disease progressive disease is defined as per RECIST 1.1 criteria based on investigator assessment	18 months
Secondary	Overall survival time (OS)	Defined as the length of time from date of randomization to the date of death due to any cause or due to lost follow up	18 months