SEQUENTIAL TREATMENT STRATEGY FOR METASTATIC COLORECTAL CANCER: A PHASE III PROSPECTIVE RANDOMIZED MULTICENTER STUDY OF CHEMOTHERAPY (CT) WITH OR WITHOUT BEVACIZUMAB AS FIRST-LINE THERAPY FOLLOWED BY TWO PHASE III RANDOMIZED STUDIES OF CT ALONE OR CT PLUS BEVACIZUMAB WITH OR WITHOUT CETUXIMAB AS SECOND-LINE THERAPY ITACa: Italian Trial in Advanced Colorectal Cancer - ITACa

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-004539-44-IT

Enrollment

1000

Registered

2007-11-12

Start date

2007-10-09

Completion date

Unknown

Last updated

2025-01-27

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

Conditions

Diagnosis of Metastatic Colonrectal cancer MedDRA version: 9.1 Level: LLT Classification code 10038099 Term: Rectosigmoid cancer stage IV

Interventions

Trade Name: AVASTIN Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Bevacizumab Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentratio

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ·Histologically or cytologically confirmed untreated metastatic or locally advanced, non resectable CRC; previous adjuvant chemotherapy for CRC or neoadjuvant/adjuvant chemoradiotherapy for rectal cancer is permitted but must have been completed at least 6 months prior to enrolment; ·Measurable disease according to RECIST criteria; ·Age ≥ 18 years and 70 years with ECOG ≤ 1; ·Estimated life expectancy of at least 12 weeks; ·Adequate hematological, hepatic and renal function.·Ability to understand and the willingness to sign a written informed consent document. 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: ·Prior treatment with cetuximab, bevacizumab or other antiEGRF or anti-angiogenesis agents; ·Prior chemotherapy for metastatic or advanced disease; ·Participation in another clinical trial with any investigational agents ≤ 30 days prior to study randomization; ·Prior immunotherapy; ·Contraindications or hypersensitivity to study drugs;

Design outcomes

Primary

Measure	Time frame
Main Objective: For the the entire sequential treatment strategy (1st and 2nd line):overall survival (OS);Secondary Objective: For the the entire sequential treatment strategy (1st and 2nd line):total progression free survival (TPFS) I line study: Primary Objective: Progression-Free Survival (PFS) Secondary Objectives: Overall Response Rate (ORR according to RECIST criteria)and Safety. II line studies: Primary Objective: Progression-Free Survival (PFS) Secondary Objectives: Overall Response Rate (ORR according to RECIST criteria)and Safety.;Primary end point(s): Overall survival(OS)	—

Measure

Time frame

Main Objective: For the the entire sequential treatment strategy (1st and 2nd line):overall survival (OS);Secondary Objective: For the the entire sequential treatment strategy (1st and 2nd line):total progression free survival (TPFS) I line study: Primary Objective: Progression-Free Survival (PFS) Secondary Objectives: Overall Response Rate (ORR according to RECIST criteria)and Safety. II line studies: Primary Objective: Progression-Free Survival (PFS) Secondary Objectives: Overall Response Rate (ORR according to RECIST criteria)and Safety.;Primary end point(s): Overall survival(OS)

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Countries

Italy

Outcome results

None listed

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