NL-OMON45151
Recruiting
Phase 3
Preoperative radiochemotherapy versus immediate surgery for resectable and borderline resectable pancreatic cancer: a multicentre randomized phase III clinical trial - PREOPANC
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Pancreatic cancer
- Sponsor
- Academisch Medisch Centrum
- Enrollment
- 244
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Histologically or cytologically confirmed 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
Exclusion Criteria
- •1\.T1 resectable tumours, centrally located with no connection to the SMA, Celiac axis, CHA or SMV/PV;2\. Clearly locally advanced, irresectable, tumours ;3\. Carcinoma of the Papilla Vateri;4\. Co morbidity precluding surgery or radiochemotherapy;5\. Distant metastases, including cytologically proven N2 lymph node metastases (base of the celiac trunk or between inferior vena cava and aorta);6\. Previous radiotherapy or chemotherapy precluding radiochemotherapy;7\. Previous active malignancy shorter than 5 years before diagnosis of pancreatic cancer;8\. Pregnancy;9\. Imminent bowel obstruction;10\. Active bleeding;11 Uncontrolled infection;12\. Anamnestically known positive status for HIV or hepatitis B or C
Outcomes
Primary Outcomes
Not specified
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