A phase III trial of postoperative cisplatin, interferon alpha-2b, and 5-FU combined with external radiation treatment versus 5-FU alone for patients with resected pancreatic adenocarcinoma

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN62866759

Enrollment

110

Registered

2005-02-16

Start date

2004-08-01

Completion date

Unknown

Last updated

2016-11-28

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

Patients in study arm A will be treated with: 1. 200 mg/m^2/day 5-Fluorouracil (5-FU) by continuous intravenous (IV) infusion on days 1 - 38 2. 30 mg/m^2 Cisplatin IV over 60 minutes (with pre- and po

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Biopsy proven completely resected (R0 or R1) pancreatic adenocarcinoma of the pancreatic head or uncinate process (American Joint Committee on Cancer [AJCC] Stage I-III) 2. Protocol treatment must begin within 12 weeks of surgery 3. Men and women over eighteen years of age

Exclusion criteria

Exclusion criteria: Does not comply with above inclusion criteria

Design outcomes

Primary

Measure	Time frame
Overall survival at two years postoperatively	—

Secondary

Measure	Time frame
1. Role and the mechanism of interferon alpha-2b in patient's chemoradiation regimen 2. Toxicity 3. Disease-free interval 4. Quality of life	—

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 3, 2026