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Pan-European Trials in Adjuvant Colon Cancer. PETACC-1: The Value of Tomudex Relative to Standard Leucovorin Modulated Bolus 5-Fluorouracil (5-FU)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN72194324
Enrollment
Unknown
Registered
2002-08-19
Start date
1998-01-01
Completion date
Unknown
Last updated
2015-01-13

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

Conditions

Colon Cancer Colon

Interventions

1. Standard Arm: LV 20 mg/m2 iv bolus followed by 425 (or 370) mg/m2 5-FU iv bolus. 2. Experimental Arm: Tomudex 3.0 mg/m2 15 min iv infusion on day 1, repeated on day 22 for eight cycles (24 weeks).

Sponsors

AstraZeneca Clinical Research Group (UK)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients with Dukes C Colon Cancer who have had a curative resection within 56 days and are fit for both treatments. Inclusion: 1. Written informed consent 2. Histologically confirmed Dukes C colon cancer 3. Curative radical resection within the last 56 days 4. Aged 18 years or over 5. World Health Organisation (WHO) performance status 0, 1

Exclusion criteria

Exclusion criteria: Not provided at time of registration

Design outcomes

Primary

MeasureTime frame
Not provided at time of registration—

Secondary

MeasureTime frame
Not provided at time of registration—

Countries

United Kingdom

Outcome results

None listed

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