EUCTR2012-003181-40-NLActive, not recruitingNot Applicable
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 enrollmentStarted: August 9, 2012Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 244
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
Investigators
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