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A Randomised Trial Comparing the Efficacy of Infusional 5-Fluorouracil (5-FU) to 5-FU plus Alpha Interferon in Patients with Unresectable Colorectal Cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN42493631
Enrollment
Unknown
Registered
2002-08-19
Start date
2002-01-01
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, Rectum Cancer Cancer

Interventions

1. Regimen A: 5-fluorouracil, continuous intravenous infusion 2. Regimen B: 5-fluorouracil, continuous intravenous infusion, plus alpha-interferon five mega units given subcutaneously three times a we

Sponsors

The Royal Marsden NHS Foundation Trust (UK)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Histological evidence of metastatic adenocarcinoma of the colon or rectum not amenable to surgery or radiotherapy 2. Patients evaluable for response must have bi-dimensionally measurable disease 3. Patients with no measurable disease 4. No prior treatment with 5-fluorouracil or other cyctotoxic agent or interferon 5. Adequate bone marrow function 6. Life expectancy of greater than 3 months 7. Eastern Cooperative Oncology Group (ECOG) performance status 0-2 8. No history of other malignant disease other than non melanotic skin cancer or carcinoma in situ of the cervix 9. No intracerebral metastases or meningeal carcinomatosis 10. No medical contraindications to treatment

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