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A randomised study of continuous infusional 5-Fluorouracil (5FU) with or without mitomycin-C in patients with neuroendocrine tumours

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN53478221
Enrollment
Unknown
Registered
2002-08-19
Start date
1995-09-12
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

Neuroendocrine tumours Cancer Malignant neoplasm of other endocrine glands and related structures

Interventions

Two arms: Regimen 1. Protracted venous infusion (PVI) 5FU 300 mg/m2/day over 24 weeks Regimen 2. PVI 5FU 300 mg/m2/day over 24 weeks Mitomycin-C 7 mg/m2 (total dose must not exceed 56 mg) four cours

Sponsors

The Royal Marsden NHS Foundation Trust (UK)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Histological evidence of neuroendocrine tumours not amenable to surgery or radiotherapy 2. Patients evaluable for response must have bi-dimensionally measurable disease as assessed by chest X-ray or computed tomography (CT) scan 3. This disease must be outside previously irradiated areas

Exclusion criteria

Exclusion criteria: Not provided at time of registration

Design outcomes

Primary

MeasureTime frame
1. Response rate 2. Toxicity 3. Time to disease progression 4. Survival 5. Quality of life—

Secondary

MeasureTime frame
No secondary outcome measures—

Countries

United Kingdom

Outcome results

None listed

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