locally advanced, primarily inoperable pancreatic carcinoma
Conditions
Interventions
Product Name: Irinotecan
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: IRINOTECAN
CAS Number: 97682-44-5
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
C
Sponsors
ABCSG (Austrian Breast & Colorectal Cancer Study Group)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Informed consent signed prior to randomization and prior to any study specific procedure • Patients with histologically proven PDAC, classified as locally advanced, primarily inoperable disease; • patients with suspicious peripancreatic lymph nodes at initial staging, accessible by surgery are included in the study • Tumor must have at least one diameter of 15 mm assessed with conventional imaging techniques (e.g. CT, MRI) and at least on diameter of 10 mm measured by contrast enhanced CT • Patients scheduled for neoadjuvant treatment by the interdisciplinary tumor board • Radiologically determinable disease defined by RECIST version 1.1 within 4 weeks prior to randomization • ECOG performance status =1 or Karnofsky =70% • Adequate hematologic function, as follows (= 7d prior to randomization): o absolute neutrophil count (ANC) =1.5 x 109/L (in case ANC is not routinely measured, as alternatively relative neutrophil count > 50% is acceptable) o white blood cell count (WBC) = 3.0 x 109/L o platelet count = 100 x 109/L o haemoglobin = 9 x g/dL • Adequate renal function, as follows (= 7d prior to randomization): o creatinine = 1.5 x upper limit of normal (ULN) or GFR >50mL/min • Adequate hepatic function, as follows (= 7d prior to randomization): o aspartate aminotransferase (ASAT) = 5 x ULN o alanine aminotransferase (ALAT) = 5 x ULN o total bilirubin = 1.5 x ULN • Any age = 18 = 75 years • Ability to comply with the protocol and attend follow up • Women of childbearing potential must have a negative serum pregnancy test done within 1 week prior to study drug administration. Women are not considered of childbearing potential in case that the following criteria applies: o after having undergone hysterectomy and/or bilateral ovarectomy and/or bilateral tubal ligation o = 60 years o with FSH and E2 in the postmenopausal range 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 112 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 112
Exclusion criteria
Exclusion criteria: • External biliary drain (Common bile duct stenting allowed) • Major surgery within 4 weeks prior to start of study treatment • Any past or current history of other malignancies (except in situ carcinoma, non-metastatic non-melanomatous skin cancers) less than 2 years prior to randomization • Any radiological suspicion, or histological proof of distant metastases or extra-pancreatic disease other than regional lymph node enlargement at initial staging • Any chemo- or radiotherapy for PDAC prior to study inclusion • Concurrent or prior systemic antitumor therapy within the last 2 years • Active infection requiring systemic treatment or any uncontrolled infections Grade 1 o Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, risk associated with study participation or IMP administration, or which, in the judgment of the investigator, would make the patient inappropriate for this study participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that in patients suffering from a primarily inoperable LAPC neoadjuvant chemotherapy followed by concurrent neoadjuvant radiochemotherapy is superior to neoadjuvant chemotherapy alone in terms of R0-resectability;Secondary Objective: To demonstrate superior efficacy of neoadjuvant chemotherapy followed by concurrent neoadjuvant radiochemotherapy to neoadjuvant chemotherapy alone with respect to tumor response, histo-pathological tumor response, progression-free survival (PFS) and/or disease-free survval (DFS) and overall survival (OS), toxicity, perioperative complications, radiochemotherapy quality assurance;Primary end point(s): Histological R0 resection rate in the IIT population;Timepoint(s) of evaluation of this end point: Surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Tumor response measured by RECIST criteria • Histo-pathological tumor response with respect to proportion of severely degenerative cancer cells • DFS as time from surgery to PDAC recurrence in R0 patients • PFS as time from randomization until disease progression • OS as time from randomization to death from any cause • occurrence of treatment related toxicities • perioperative complications classified according to Clavien and Dindo • total duration and interruptions of concurrent neoadjuvant radiochemotherapy, total dose of the radiotherapy and administration of concomitant chemotherapy;Timepoint(s) of evaluation of this end point: • Tumor response, histo-pathological tumor response, perioperative complications, toxicities: after neoadjuvant treatment and surgery • DFS, PFS, OS: after last patient had last FU-Visit | — |
Countries
Austria
Contacts
Public ContactTrial Office
ABCSG (Austrian Breast & Colorectal Cancer Study Group)
Outcome results
None listed