resectable pancreatic carcinoma or borderline resectable pancreatic carcinoma resectabel of borderline resectabel pancreascarcinoom.
Conditions
Interventions
Two arm, randomized trial for patients with resectable or borderline resectable pancreatic cancer.
Standard arm: Explorative surgery, if possible resulting in pylorus preserving or classical panc
Sponsors
Academic Medical Center
Department of radiation oncology
Meibergdreef 9
1105 AZ Amsterdam
The Netherlands
Phone: +31 20 5665591
E-mail: g.vantienhoven@amc.uva.nl
Eligibility
Inclusion criteria
Inclusion criteria: 1. Histologically or cytologically confirmed adenocarcinoma of the pancreas; 2. Primarily resectable tumours or Borderline resectable tumours (see table 1, p7 and hereunder) (exception, T1 centrally located tumours with no vascular involvement at all); 3. WHO performance status ≤ 1; 4. Ability to undergo surgery and radiochemotherapy; 5. Leucocytes ≥ 3.5 X 109/l; 6. Platelets ≥ 100X 109 /l; 7. Haemoglobin ≥ 6 mmol/l; 8. Renal function: E-GFR > 50 ml/min; 9. Age ≥ 18 years; 10. Written informed consent; 11. Patients with reproductive potential must use effective contraception.
Exclusion criteria
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 (see table 1, p7 and hereabove); 3. Carcinoma of the Papilla Vateri; 4. Co morbidity precluding surgery or radiochemotherapy; 5. Previous radiotherapy or chemotherapy precluding radiochemotherapy; 6. Distant metastases, including cytologically proven N2 lymph node metastases (base of the celiac trunk or between inferior vena cava and aorta); 7. Pregnancy; 8. Imminent bowel obstruction; 9. Active bleeding; 10. Uncontrolled infection; 11. Anamnestically known positive status for HIV or hepatitis B or C.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival. | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare between the study arms: 1. The resection rate; 2. The microscopically complete (R0) resection rate; 3. The disease free survival; 4. The time to locoregional failure; 5. The time to distant metastases; 6. The postoperative complications and morbidity. To assess in the experimental arm: 1. The radiological response rates after preoperative radiochemotherapy (RECIST criteria); 2. The pathological response rates after preoperative radiochemotherapy; 3. The toxicity of preoperative radiochemotherapy according to Common Terminology Criteria for Adverse Events 4 (CTC-AE 4). | — |
Contacts
Public ContactG. Tienhoven, van
Academic Medical Center Department of radiation oncology Meibergdreef 9
Outcome results
None listed