A Randomised Study of continuous infusion 5-Fluorouracil (5FU) with or without bolus Mitomycin-C in Patients with Advanced Pancreatic Cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN61961630

Enrollment

208

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

Pancreatic cancer Cancer Malignant neoplasm of pancreas

Interventions

Two Arms: 1. Protracted venous infusion (PVI) 5FU 300 mg/m2/day over 24 weeks 2. PVI 5FU 300 mg/m2/day over 24 weeks MMC 7 mg/m2 (total dose not to exceed 56 mg) four courses over 24 weeks

Eligibility

Inclusion criteria

Inclusion criteria: Histological evidence of locally advanced or metastatic carcinoma of the pancreas not amenable to surgery or radiotherapy. Alternatively patients would have radiologically measurable evidence of locally advanced or metastatic carcinoma of the pancreas not amenable to surgery or radiotherapy, without histological evidence but with a carcinoembryonic antigen (CEA) above 50.

Exclusion criteria

Exclusion criteria: Does not match inclusion criteria

Design outcomes

Primary

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

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