patients with resectable or borderline resectable pancreatic cancer.
Conditions
Interventions
Trade Name: Gemcitabine
Pharmaceutical Form: Powder and solvent for solution for injection
Sponsors
Foundation for Liverdisease
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: to compare between the study arms - the resection rate - the microscopically complete (R0) resection rate - the disease free survival - the time to locoregional failure - the time to distant metastases - the postoperative complications and morbidity To assess in experimental arm - the radiological response rates after preoperative radiochemotherapy (RECIST criteria) - the pathological response rates after preoperative radiochemotherapy - the toxicity of preoprative radiochemotherapy according to Common Terminology Criteria of Adverse Events 4 (CTC-AE-4) ;Primary end point(s): Overall survival is defined as the period of time between randomization and death from any cause. Patients alive at last follow-up are censored.;Timepoint(s) of evaluation of this end point: One of the interim analysis is planned after 100 patients have been followed until death or for at least 12 months after inclusion. All cause actuarial survival curves in the two randomization groups will be compared by intent to treat The log rank test statistics will be used to compare the Kaplan-Meier survical curves of two randomization groups;Main Objective: To investigate whether the addition of preoperative radiochemotherapy to the standard treatment, consisting of explorative laparotomy, pancreaticoduodenectomy if possible, followed by adjuvant chemotherapy, improves the overall survival (analyzed by intent to treat) of patients with resectable or borderline resectable pancreatic cancer. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - 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) by the International Study Group on Pancreatic Surgery (analysis on intent-to-treat and per-protoc | — |
Countries
Netherlands
Contacts
Public ContactProf Dr C.H.J. van Eijck
Foundation of Liverdisease
Outcome results
None listed