(borderline) resectable pancreatic cancer MedDRA version: 21.0 Level: LLT Classification code 10033602 Term: Pancreatic adenocarcinoma resectable System Organ Class: 100000004864
Conditions
Interventions
Trade Name: LEUCOVORIN CALCIUM
Product Name: Leucovorin calcium
Pharmaceutical Form: Powder for solution for injection/infusion
INN or Proposed INN: Calcium folinate
CAS Number: 1492-18-8
Current Spo
Sponsors
Erasmus Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Histologically or cytologically confirmed pancreatic cancer (i.e. pancreatic ductal adenocarcinoma) • (Borderline) resectable tumor without metastatic disease* (see table 1 for definitions of resectability) • WHO performance status 0 or 1 • Ability to undergo surgery, chemoradiotherapy and chemotherapy** • Leucocytes (WBC) = 3.0 X 109/l • Platelets = 100X 109 /l • Hemoglobin = 6 mmol/l • Renal function: E-GFR = 50 ml/min • Age = 18 years • Written informed consent 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 300 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 68
Exclusion criteria
Exclusion criteria: • Prior radiotherapy, chemotherapy, or resection for pancreatic cancer. • Prior radiotherapy or chemotherapy precluding chemoradiotherapy or FOLFIRINOX • Previous malignancy (excluding non-melanoma skin cancer, pancreatic neuroendocrine tumor (pNET) <2cm, and gastrointestinal stromal tumor (GIST) <2cm), unless no evidence of disease and diagnosed more than 53 years before diagnosis of pancreatic cancer, or with a life expectancy of more than 5 years from date of inclusion. • Pregnancy. • Serious concomitant systemic disorders that would compromise the safety of the patient or his/her ability to complete the study, at the discretion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether neoadjuvant FOLFIRINOX followed by surgery improves overall survival compared to neoadjuvant chemoradiotherapy followed by surgery and adjuvant gemcitabine in patients with (borderline) resectable pancreatic cancer in an intention-to-treat setting.;Secondary Objective: To compare between the study arms: •Chemotherapy rate •Chemotherapy completion rate •Staging laparoscopy rate •Laparoscopy yield •Exploratory laparotomy rate •Resection rate •R0 resection rate •Progression-free survival (PFS) •Locoregional failure free interval (LFFI) •Distant metastases free interval (DMFI) •Postoperative complications •Toxicity •Quality of life years (QALYs) •Indirect and direct medical and nonmedical costs •Incremental cost-effectiveness ratio (ICER) •Predictive value of biomarkers in serum and resected tumors. •Disease free survival (DFS) •Locoregional recurrence free interval (LRFI) •Clinical response rate •Serum Cancer Antigen 19-9 (CA 19.9) and Carcino-Embryonal-Antigen (CEA) response •Pathologic response;Primary end point(s): •Overall survival (OS), 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: end of study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Chemotherapy rate, defined as the percentage of eligible randomized patients who received at least one cycle of chemotherapy. • Chemotherapy completion rate, defined as the percentage of eligible randomized patients who completed all cycles of scheduled chemotherapy. • Exploratory laparotomy rate, defined as the percentage of eligible randomized patients who actually underwent an exploratory laparotomy, regardless whether a resection was performed. • Resection rate, defined as the percentage of eligible randomized patients that underwent a curative-intent resection. • R0 resection rate, defined as the percentage of eligible randomized patients that underwent a microscopically complete (R0) resection. The resection is considered R0 if the inked margin is more than 1 mm away from tumor cells. • Progression-free survival, defined as survival without locoregional progressive disease , the occurence of distant metastases, the occurence of second or recurrent pancreatic cancer from the date of randomization. Death from any cause is also considered an event for this endpoint. • Locoregional failure free interval (LFFI), defined as the period of time without locoregional failure after randomization. A locoregional failure is any progressive or recurrent pancreatic cancer in the original tumor location, or the N1 lymph node areas, or the occurrence of second pancreatic cancer. • Distant metastases free interval (DMFI), defined as the period of time without distant metastases after randomization. • Postoperative complications, defined according to the Clavien-Dindo classification and definitions of post-pancreatic surgery complications (pancreatic fistula, delayed gastric emptying, and bleeding) by the International Study Group on Pancreatic Surgery. • Toxicity, gastro-intestinal and hematologic, according to CTCAE version 4.0.3, until 90 days after the last dose of chemotherapy. • Quality of life years (QALYs) from randomization until last follow | — |
Countries
Netherlands
Contacts
Public Contactproject manager
Erasmus Medical Center
Outcome results
None listed