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A randomised trial of infusional 5-fluorouracil and concomitant radiotherapy in locally advanced rectal cancer, comparing three and six months of infusional 5-fluorouracil

A randomised trial of infusional 5-fluorouracil and concomitant radiotherapy in locally advanced rectal cancer, comparing three and six months of infusional 5-fluorouracil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN93845533
Enrollment
Unknown
Registered
2002-08-19
Start date
1990-01-01
Completion date
Unknown
Last updated
2019-02-11

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

Conditions

Cancer of rectum Cancer

Interventions

All patients receive continuous infusional 5-fluorouracil for 12 weeks plus radiotherapy to the pelvis, minimum 45 Gy given in twenty-five fractions over 5 weeks to start at the beginning of the 5th w

Sponsors

The Royal Marsden NHS Foundation Trust (UK)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Histologically verified adenocarcinoma of the rectum, which is either: 1.1. Inoperable primary tumour 1.2. Locally recurrent tumour 1.3. Residual pelvic disease after resection as assessed either surgically or histopathologically 2. No evidence of metastatic disease 3. No past history of malignancy 4. No previous radiotherapy to the pelvis 5. Normal bone marrow, liver and renal function 6. No concurrent severe or life threatening illness

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