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A randomised trial of adjuvant 5-fluorouracil, leucovorin and radiotherapy in colorectal adenocarcinoma

A randomised trial of adjuvant 5-fluorouracil, leucovorin and radiotherapy in colorectal adenocarcinoma

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN88796215
Enrollment
Unknown
Registered
2002-08-19
Start date
2002-08-01
Completion date
Unknown
Last updated
2016-10-17

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

Conditions

Colon, Rectal cancer Cancer 1. Malignant neoplasm of colon 2. Malignant neoplasm of rectum

Interventions

COLON CANCER: Following surgery patients are randomised to one of two groups: 1. Group A: No adjuvant therapy 2. Group B: Adjuvant chemotherapy with 5-fluorouracil and folinic acid repeated every 14

Sponsors

Wyeth-Lederle Ltd (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 80 years 2. World Health Organisation (WHO) performance status zero to two 3. Histological proof of colorectal adenocarcinoma 4. The entire colorectum must be visualised pre- or postoperatively to exclude synchronous carcinoma 5. Potentially curative surgery 6. Adjuvant treatment to be initiated within six weeks of surgery 7. Adequate bone marrow, renal and hepatic function

Exclusion criteria

Exclusion criteria: No previous malignancy except carcinoma in situ of cervix or basal cell carcinoma of skin

Design outcomes

Secondary

MeasureTime frame
Not provided at time of registration—

Primary

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