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

NCT ID: NCT05316818

Last Updated: 2022-04-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-16
• Study Completion Date: 2021-04-10

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

Conditions

Metastatic Colorectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Triplet regimen (FOLFOXIRI)

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

Group Type: EXPERIMENTAL

FOLFOXIRI Protocol

Intervention Type: DRUG

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

standard duplet regimen (FOLFOX or FOLFIRI)

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

Group Type: ACTIVE_COMPARATOR

FOLFOXIRI Protocol

Intervention Type: DRUG

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

Interventions

FOLFOXIRI Protocol

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kasr El Aini Hospital

OTHER

Sponsor Role: lead

Responsible Party

Khaled Ahmed Khalil Hassan

Assistant lecturer of clinical oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kasr El AiniH

Cairo, El Manial, Egypt

Countries

Egypt

Other Identifiers

I-160317

Identifier Type: -

Identifier Source: org_study_id