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A Prospective Randomised Multicentre Phase III Clinical Trial Comparing the Effects of Panorex Injection Plus 5-Fluorouracil (5-FU)/Leucovorin versus 5-Fluorouracil/Leucovorin versus PANOREX alone, in patients with Surgically resected Stage III (Dukes C) Carcinoma of the Colon

A Prospective Randomised Multicentre Phase III Clinical Trial Comparing the Effects of Panorex Injection Plus 5-Fluorouracil (5-FU)/Leucovorin versus 5-Fluorouracil/Leucovorin versus PANOREX alone, in patients with Surgically resected Stage III (Dukes C) Carcinoma of the Colon

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN18439984
Enrollment
Unknown
Registered
2002-08-19
Start date
1998-01-01
Completion date
Unknown
Last updated
2020-04-20

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

Conditions

Colon cancer Cancer Colon

Interventions

1. Arm 1: Panorex (900 mg) (1 x 500 mg 5-FU, 4 x 100 mg Luecovorin) 2. Arm 2: 5-FU - 425 mg/m2/d x 5 days for six courses
Leucovorin - 20 mg.m2/day x 5 days for six courses 3. Arm 3: Panorex alone (900 mg)

Sponsors

Glaxo Wellcome (UK)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Histopathologically documented stage III (Dukes C) colon cancer 2. Less than 6 weeks since surgical removal of the tumour 3. Tumour-free margin of resection 4. Total resection of tumour by laparoscopy is an exclusion 5. Age >18: World Health Organisation (WHO) performance status of 0, 1 or 2: Life expectancy at least 12 months 6. Adequate haematological, hepatic and renal function 7. No metastatic, recurrent, locally advanced cancer or previous history of cancer

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