A Randomised Trial of 5-Fluorouracil (5FU) and Leucovorin (LV) versus 5-Fluorouracil, leucovorin and Interferon-Alpha 2a for Advanced Colorectal Adenocarcinoma

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN95638591

Enrollment

260

Registered

2002-08-19

Start date

2000-08-01

Completion date

Unknown

Last updated

2019-12-10

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

Conditions

Advanced colorectal adenocarcinoma Cancer

Interventions

Patients are randomised to one of two treatment arms: 1. Arm 5FU-LV: Chemotherapy with 5-fluorouracil and leucovorin repeated every 14 days for six cycle. Following reassessment patie

Eligibility

Inclusion criteria

Inclusion criteria: 1. Histologically confirmed adenocarcinoma of the colon or rectum not amenable to surgery or radiotherapy 2. Objectively assessable disease 3. No previous treatment with 5-fluorouracil or interferon 4. Adequate bone marrow function 5. No concurrent uncontrolled medical illness 6. Not on systemic corticosteroids at the time of study entry 7. Life expectancy of >3 months 8. World Health Organisation (WHO) performance status 0-2

Exclusion criteria

Exclusion criteria: Not provided at time of registration.

Design outcomes

Primary

Measure	Time frame
Not provided at time of registration.	—

Secondary

Measure	Time frame
Not provided at time of registration.	—

Countries

United Kingdom

Outcome results

None listed

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