Phase II prospective randomized multicenter study of Folfiri versus Folfiri Cox-2 inhibitor versus Folfiri followed by Cox-2 inhibitor in the first-line treatment of colo-rectal cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-000591-13-IT

Enrollment

159

Registered

2007-03-14

Start date

2004-09-28

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

First-line treatment of colo-rectal cancer MedDRA version: 6.1 Level: PT Classification code 10061045

Interventions

Trade Name: CELEBREX Product Name: CELECOXIB Pharmaceutical Form: Capsule, hard CAS Number: 169590-42-5 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200-

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Main Objective: PFS AFTER 1 YEAR;Secondary Objective: OR, OS AND SAFETY- COX-2 ENZYME EVALUATION IN SAMPLES TISSUE - VEGF EVALUATION;Primary end point(s):	—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026