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A randomised study of continuous infusional 5-Fluorouracil (5FU) with or without bolus mitomycin-C in patients with carcinoma of unknown primary origin

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN63374575
Enrollment
88
Registered
2002-08-19
Start date
1995-01-01
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

Carcinoma of unknown primary origin Cancer Malignant neoplasm without specification of site

Interventions

1. Regimen 1. Protracted Venous Infusion (PVI) 5FU 300 mg/m/day over 24 weeks 2. Regimen 2. PVI 5FU 300 mg/m/day over 24 weeks Mitomycin-C 7 mg/m (total not to exceed 56 mg). Four courses over 24 wee

Sponsors

The Royal Marsden NHS Foundation Trust (UK)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Histological evidence of carcinoma of unknown primary site 2. Patients evaluable for response 3. Must have bi-dimensionally measurable disease as assessed by chest X-ray or Computed Tomography (CT) scan 4. Disease must be outside previously irradiated areas

Exclusion criteria

Exclusion criteria: Not provided at time of registration

Design outcomes

Primary

MeasureTime frame
Added 05/08/09: 1. tumour response 2. survival 3. toxicity 4. quality of life (QoL)

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