EUCTR2012-003181-40-NL
Active, Not Recruiting
N/A
Preoperative radiochemotherapy versus immediate surgery for resectable and borderline resectable pancreatic cancer: a multicentre randomized phase III clinical trial - PREOPANC
Foundation for Liverdisease0 sites244 target enrollmentAugust 9, 2012
Conditionspatients with resectable or borderline resectable pancreatic cancer.Therapeutic area: Diseases [C] - Cancer [C04]
DrugsGemcitabine
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- patients with resectable or borderline resectable pancreatic cancer.
- Sponsor
- Foundation for Liverdisease
- Enrollment
- 244
- Status
- Active, Not Recruiting
- Last Updated
- 13 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
Not specified
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