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

Phase 3

Completed

• Conditions: Pancreatic cancer; Cancer; Malignant neoplasm of pancreas

• Registration Number: ISRCTN62866759
• Lead Sponsor: niversity of Heidelberg (Germany)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-02-16
• Last Update Posted: 28 November 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 110

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

Does not comply with above inclusion criteria

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival at two years postoperatively

Secondary Outcome Measures

Name	Time	Method
1. Role and the mechanism of interferon alpha-2b in patient's chemoradiation regimen<br>2. Toxicity<br>3. Disease-free interval <br>4. Quality of life