Randomised phase II/III study comparing gemcitabine followed by gemcitabine plus concomitant radiation (50.4 Gy) versus gemcitabine alone after curative pancreaticoduodenectomy for pancreatic head cancer

• Conditions: Pancreatic head Cancer; MedDRA version: 7.0Level: LLTClassification code 10007071

• Registration Number: EUCTR2005-000933-39-DE
• Lead Sponsor: European Organisation for Research and Treatment of Cancer

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-04-13
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 538

Inclusion Criteria

History of pancreas head adenocarcinoma with R0 pancreaticoduodenectomy Documented histological examination of surgical margins including retroperitoneal margin. The examination must have been performed during the surgical process and by using frozen sections.
Proper documentation related to the number of lymph nodes (< 10 lymph nodes vs = 10 lymph nodes) examined according to the UICC 1997 criteria
Adequate liver (bilirubin < 1.5 times normal, ASAT / ALAT< 3.0 times normal) and renal
(creatinin < 1.2 mg/dl) functions
Presence of adequate contraception in fertile patients. Pregnant and lactating women are excluded.
Hb> 9.0 g/dl or 5.6 mmol/L, platelets > 150000 /mm3 , WBC > 3500/mm3
Abdominal spiral CT scan (with contrast enhancement) performed after surgery and/or a spiral CT scan performed before surgery but not older than 8 weeks at the time of randomization
Age > or = 18
ECOG/WHO PS < or = 2
Complete recovery from surgery within 8 weeks
Before patient registration/randomization, written informed consent must be given according to ICH GCP, and national/local regulations
Before patient registration /randomization , QoL assessment should have been completed
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

No previous or coexistant malignant disease except BCC of the skin or carcinoma in situ of the cervix
No previous chemotherapy or radiotherapy

Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
No periampullary cancer

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified