locally advanced pancreatic adenocarcinoma MedDRA version: 14.1 Level: LLT Classification code 10051971 Term: Pancreatic adenocarcinoma System Organ Class: 100000004864
Conditions
Sponsors
ABCSG (Austrian Breast & Colorectal Cancer Study Group)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients with histologically proven PDAC, classified as locally advanced disease, borderline resectable, if one or more of the following criteria are detectable: o Tumor-associated deformity of the superior mesenteric vein (SMV) or portal vein (PV) o Abutment of the SMV or PV = 180° o Short-segment occlusion of the SMV or PV amenable to resection and venous reconstruction o Short-segment involvement of the hepatic artery (HA) or its branches amenable to resection and reconstruction o Abutment of the superior mesenteric artery (SMA) =180° • Patients scheduled for neoadjuvant treatment by the interdisciplinary tumour board • Radiologically determinable disease defined by RECIST version 1.1 within 4 weeks prior to randomization • Patients with suspicious peripancreatic lymph nodes at initial staging, accessible by surgery are included in the study • ECOG performance status =1 (see Appendix 4) or Karnofsky =70% • Adequate hematologic function, as follows (= 28 d prior to randomization): o absolute neutrophil count (ANC) = 1.5 x 109/L (in case ANC is not routinely measured, as alternative relative neutrophil count > 50% is acceptable) o leucocyte count=3.0 x 109/L o platelet count = 100 x 109/L o haemoglobin = 9 x g/dL • Adequate renal function, as follows (= 28 d prior to randomization): o creatinine = 1.5 x upper limit of normal (ULN) • Adequate hepatic function, as follows (= 28 d prior to randomization): o aspartate aminotransferase (ASAT) = 5 x ULN o alanine aminotransferase (ALAT) = 5 x ULN o total bilirubin = 2.5 x ULN • Any age = 18-80 years • Life expectancy > 6 months • Informed consent signed prior to randomization and prior to any study specific procedure • Ability to comply with the protocol and attend follow up • Women of childbearing potential must have a negative serum pregnancy test done 1 week prior to study drug administration. Patients are not considered of childbearing potential: o after having undergone hysterectomy and/or bilateral ovarectomy 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 51 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 39
Exclusion criteria
Exclusion criteria: • Major surgery within 4 weeks prior start of study treatment • Any past or current history of other malignancies 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 PDCA prior to study inclusion • Concurrent or prior systemic antitumor therapy within the last 2 years • Active infection requiring systemic treatment or any uncontrolled infections 1 o Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or IMP administration, or which, in the judgment of the investigator, would make the patient inappropriate for enrolment into this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that in patients suffering from locally advanced PDAC, the addition of radiochemotherapy to standard neoadjuvant chemotherapy is superior to chemotherapy alone with respect to R0 resection rate.;Secondary Objective: To demonstrate superior efficacy of radiochemotherapy to neoadjuvant chemotherapy with respect to • Tumor response according to RECIST criteria • Progression- (PFS) and/or disease-free survival (DFS) and overall survival (OS) • Toxicity according to NCI CTCAE v.4.0 • Perioperative complications • Radiochemotherapy quality assurance (adherence to protocol) ;Primary end point(s): Histological R0 resection rate in the intention to treat group.;Timepoint(s) of evaluation of this end point: Evaluation after neoadjuvant treatment and 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 (see appendix 8) • total duration and interruptions of radiochemotherapy, total dose of the radiotherapy and administration of concomitant chemotherapy during radiotherapy ;Timepoint(s) of evaluation of this end point: • Tumor response, histo-pathological tumor response, perioperative complications: Evaluation after neoadjuvant treatment and surgery. • DFS, PFS and OS: Evaluation after last patient had the last follow-up visit | — |
Countries
Austria
Contacts
Public ContactTrial Office
ABCSG /Austrian Breast & Colorectal Cancer Study Group)
Outcome results
None listed