Pancreatic cancer
Conditions
Interventions
Laparoscopy
In the radiochemotherapy arm, a laparoscopy will be planned so that the start
of radiochemotherapy will not be later than 4 weeks after randomization.
Laparoscopy is performed according
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint Overall survival is defined as the period of time between randomization and death from any cause. Patients alive at last follow-up are censored. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints that will be compared between the randomization arms are defined as follows: - Resection rate is defined as the percentage of eligible randomized patients that actually underwent a resection. Patients that do not undergo an explorative laparotomy at all or do undergo an explorative laparotomy but not a resection are considered a failure. - R0 resection rate is defined as the percentage of eligible randomized patients that underwent a microscopically complete (or R0) resection. The resection is considered R0 if the inked margin is further than 1 mm distinct from any tumour cells. - Disease free survival is defined as survival without overt recurrent pancreatic cancer from the date of randomization, as discovered following complaints of the patient or on routine CT-scan at 6 months intervals. Any sign of recurrent or persistent disease, locoregional or distant, as well as death from any cause is considered an event for this endpoint. Patients that do not undergo an explorative laparotomy at all or do undergo an explorative laparotomy but not a resection are considered a failure at time point zero. - Time to locoregional failure is defined as the period of time without locoregional recurrence after randomisation. Locoregional recurrence is considered an event and patients are censored at death or distant metastases without locoregional recurrence. Patients that do not undergo an explorative laparotomy at all or do undergo an explorative laparotomy but not a resection are considered a failure at time point zero. - Time to distant metastases is defined as the period of time without distant metastases after randomisation. Distant metastases are considered an event and patients are censored at death. - Postoperative complications are defined according to the internationally-accepted Clavien-Dindo classification and definitions of post-pancreatic surgery complications (pancreatic fistula, delayed gastric emptying, bleeding) b | — |
Countries
Netherlands
Outcome results
None listed