Preoperative radiochemotherapy versus immediate surgery for resectable and borderline resectable pancreatic cancer: a multicentre randomized phase III clinical trial

Phase 3

Recruiting

Conditions: Pancreatic cancer
10015674
10017991

Registration Number: NL-OMON45151

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 244

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint<br /><br><br /><br>Overall survival is defined as the period of time between randomization and<br /><br>death from any cause. Patients alive at last follow-up are censored.</p><br>

Secondary Outcome Measures