NCT00005979 is a Phase 3 clinical trial of FOLFIRI regimen in Colorectal Cancer, sponsored by UNICANCER.

Who is sponsoring NCT00005979?

NCT00005979 is sponsored by UNICANCER.

What drugs are being tested in NCT00005979?

Interventions in NCT00005979: FOLFIRI regimen, fluorouracil, irinotecan hydrochloride, leucovorin calcium.

What condition does NCT00005979 study?

NCT00005979 studies Colorectal Cancer.

Is NCT00005979 still recruiting?

NCT00005979 is currently completed. Last updated 17 February 2021.

Last reviewed 2021-02-17 · How we verify

NCT00005979

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Combination Chemotherapy With or Without Irinotecan in Treating Patients With Stage III Colon Cancer

Completed Phase 3 Last updated 17 February 2021

What this trial tests

Phase 3 trial testing FOLFIRI regimen in Colorectal Cancer. Completed in 1 September 2007.

Timeline

22 July 1998

Primary endpoint
26 September 2005

1 September 2007

Quick facts

Lead sponsor	UNICANCER
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Primary purpose	treatment
Start date	22 July 1998
Primary completion	26 September 2005
Estimated completion	1 September 2007
Sites	30 locations across France

Drugs / interventions tested

FOLFIRI regimen — full drug profile →
fluorouracil — full drug profile →
irinotecan hydrochloride (Irinotecan Hydrochloride) — full drug profile →
leucovorin calcium

Conditions studied

Colorectal Cancer — all drugs for Colorectal Cancer →

Sponsor

UNICANCER — full company profile →

Who can join

Adults 18 to 75, any sex, with Colorectal Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known if combination chemotherapy is more effective with or without irinotecan in treating colon cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without irinotecan in treating patients who have stage III colon cancer.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of FOLFIRI regimen

Trials testing the same drug.

NCT05983367 — A Study to Investigate Ompenaclid Combined With FOLFIRI Plus Bevacizumab in Advanced/Metastatic Colorectal Cancer · Phase 2 · terminated
NCT04926545 — XCHT for Irinotecan-Induced Gut Toxicities (Run-in Study) · NA · completed
NCT03635021 — Study to Evaluate the Efficacy of FOLFOX + Panitumumab Followed by FOLFIRI + Bevacizumab (Sequence 1) Versus FOLFOX + Be · Phase 3 · active not recruiting
NCT00066274 — Comparison of Combination Chemotherapy Regimens in Treating Patients With Metastatic Colorectal Cancer · Phase 2 · completed
NCT00023868 — Combination Chemotherapy With or Without Chemoembolization in Treating Patients With Colorectal Cancer Metastatic to the · Phase 3 · terminated

Other recruiting trials for Colorectal Cancer

Currently open trials in the same condition.

NCT07152821 — Botensilimab + Balstilimab vs Best Supportive Care as Therapy in Chemo-refractory, Unresectable, Colorectal Adenocarcino · Phase 3 · recruiting
NCT07353645 — KRAS Neoantigen Nanovaccine as Adjuvant Therapy for Colorectal Cancer/Pancreatic Cancer · Phase 1, PHASE2 · recruiting
NCT07432633 — [18F]FPyQCP PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications · Phase 1, PHASE2 · recruiting
NCT07523919 — Functional and Respiratory Determinants of Long-Term Colorectal Cancer Outcomes · recruiting
NCT07529301 — Functional and Respiratory Predictors of Early Postoperative Outcomes · recruiting

Other UNICANCER trials

Trials by the same sponsor.

NCT07340619 — Clinical Trial Evaluating the Biological Activity of a New Drug Identified as Prifetrastat (PF-07248144), Combined With · Phase 2 · not yet recruiting
NCT07340567 — Personalizing Chemotherapy Selection After Surgery for Patients With Stage III Colorectal Cancer Using a Blood Test · Phase 3 · not yet recruiting
NCT07360834 — Study Aiming to Test Whether Non-invasive Liquid Biopsies Can Safely Reduce Invasive Surveillance Methods in Lynch Syndr · NA · not yet recruiting
NCT07106632 — Optimising Adjuvant Chemotherapy Prescription in Young Patients With Hormone-dependent Breast Cancer Using Genomic Tests · Phase 3 · not yet recruiting
NCT07294430 — Antibody-based PET Imaging and Treatment Response in Breast Cancer Treated With an Antibody-drug Conjugate. · Phase 2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00005979 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by UNICANCER
Last refreshed: 17 February 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00005979.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing