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FOLFIRI vs XELIRI in the treatment of advanced colo-rectal untreated carcinoma: a phase II randomized study of the Gruppo Oncologico dell'Italia Meridionale - ND

FOLFIRI vs XELIRI in the treatment of advanced colo-rectal untreated carcinoma: a phase II randomized study of the Gruppo Oncologico dell'Italia Meridionale - ND

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-002181-11-IT
Enrollment
Unknown
Registered
2007-07-05
Start date
2005-07-12
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

Untreated colo-rectal carcinoma MedDRA version: 9.1 Level: LLT Classification code 10052360 Term: Colorectal adenocarcinoma

Interventions

Trade Name: CAMPTO*1FL 100MG/5ML Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Irinotecan CAS Number: 136572-09-3 Concentration unit: mg milligram(s) Concentration ty

Sponsors

OSPEDALE ONCOLOGICO DI BARI
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Locally advanced or metastatic colo-rectal carcinoma 2. Presence of at least one measurable lesion 3. Age between 18 and 75 years 4. Life expectancy >= 3 months 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: 1. Brain metastasis 2. Previous chemotherapy for locally advanced or metastatic colo-rectal carcinoma 3. Pregnancy and breast-feeding 4. Any other contemporary tumour

Design outcomes

Primary

MeasureTime frame
Main Objective: Percentage of objective responses of the combination XELIRI with respect to FOLFIRI;Secondary Objective: 1. Safeness of the combination 2. Average time of the progression 3. Average duration of the response 4. Global survival;Primary end point(s): To estimate the two combinations FOLFIRI vs XELIRI—

Countries

Italy

Outcome results

None listed

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