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

NCT05316818 | Completed Phase 2

• 1 other identifier: I-160317
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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

Conditions

Metastatic Colorectal Cancer

Keywords

First line chemotherapy; FOLFOXIRI; standard doublet; Efficacy; Toxicity

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (2)

• Progression free survival (PFS)

  18 months

• Overall survival time (OS)

  18 months

Study Arms (2)

Triplet regimen (FOLFOXIRI)

EXPERIMENTAL

The treatment planned consisted of irinotecan 160 mg/m² in 250 ml of NaCl 0.9% over 1 hr, followed by 85 mg/m² oxaliplatin in 250 ml dextrose 5% given concurrently with a 400 mg/m² leucovorin intra venous infusion in 250 ml dextrose 5% for 120 min, followed by 2400 mg/m² for 44-hr continuous infusion

Drug: FOLFOXIRI Protocol

standard duplet regimen (FOLFOX or FOLFIRI)

ACTIVE COMPARATOR

Regimen consisted of 180 mg/m² intravenous infusion of irinotecan for 60 min OR 85 mg/m² oxaliplatin day 1 only followed by a 200 mg/m² intra venous infusion of leucovorin for 120 min, a 400 mg/m² intravenous bolus of fluorouracil, and a 600 mg/m² continuous infusion of fluorouracil for 22 hr to be repeated on day 2

Drug: FOLFOXIRI Protocol

Interventions

FOLFOXIRI Protocol DRUG

Triplet chemotherapy regimen consists from active three cytotoxic agents aiming to improve outcomes

Triplet regimen (FOLFOXIRI); standard duplet regimen (FOLFOX or FOLFIRI)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Kasr El AiniH

Cairo, El Manial, 11555, Egypt

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

FOLFOXIRI protocol

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer of clinical oncology

Study Record Dates

• First Submitted: March 7, 2022
• First Posted: April 7, 2022
• Study Start: January 16, 2018
• Primary Completion: December 1, 2020
• Study Completion: April 10, 2021
• Last Updated: April 7, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)