Preoperative chemotherapy and radiotherapy versus direct surgery in patients with pancreatic cancer: a multicentre study

• Conditions: patients with resectable or borderline resectable pancreatic cancer.; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-003181-40-NL
• Lead Sponsor: Foundation for Liverdisease

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08-09
• Last Update Posted: 17 December 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 244

Inclusion Criteria

1. Histologically or cytologicallyconfirmed adenocarcinoma of the pancreas
2. Primarilly resectable tumours or Borderline resectable tumours
3. Karnofsky performance status = 70%
4. Ability to undergo surgery and radiochemotherapy
5. Leucocytes = 3.5 X 10.9/l
6. Platelets = 100X 10.9/l
7. Hemoglobin = 6 mmol/l
8. renal function: E-GFR > 50 ml/min
9. Age = 18 jaar
10.Written informed concent
11. Patients with reproductive potential must use effective contraception
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 244
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 244

Exclusion Criteria

1.T1 resectable tumours, centrally located with no connection to the SMA, Celiac axis, CHA or SMV/PV
2. Claerly locally advanced, irresectable, tumours
3. Carcinoma of the Papilla Vateri
4. Co morbidity precluding surgery or radiochemotherapy
5. Distant metastases, including cytologically prove N2 lymph node metastases (base of the celiac trunk or between inferior vena cava and aorta)
6. Previous treatment of pancreatic cancer (i.e. radiotherapy or chemotherapy)
7. Pregnancy
8. Imminent bowel obstruction
9. Active bleeding
10 Uncontrolled infection
11 Anamnestically known positive status for HIV or hepatitis B or C

Study & Design

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