P01 - A prospective, randomized, multicenter trial of additional radiochemotherapy to neoadjuvant chemotherapy in patients with locally advanced pancreatic adenocarcinoma

• Conditions: locally advanced pancreatic adenocarcinoma; MedDRA version: 14.1Level: LLTClassification code 10051971Term: Pancreatic adenocarcinomaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-001028-21-AT
• Lead Sponsor: ABCSG (Austrian Breast & Colorectal Cancer Study Group)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04-12
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

•Patients with histologically proven PDAC, classified as locally advanced disease, borderline resectable, if one or more of the following criteria are detectable:
oTumor-associated deformity of the superior mesenteric vein (SMV) or portal vein (PV)
oAbutment of the SMV or PV = 180°
oShort-segment occlusion of the SMV or PV amenable to resection and venous reconstruction
oShort-segment involvement of the hepatic artery (HA) or its branches amenable to resection and reconstruction
oAbutment 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):
oabsolute neutrophil count (ANC) = 1.5 x 109/L (in case ANC is not routinely measured, as alternative relative neutrophil count > 50% is acceptable)
oleucocyte count=3.0 x 109/L
oplatelet count = 100 x 109/L
ohaemoglobin = 9 x g/dL
•Adequate renal function, as follows (= 28 d prior to randomization):
ocreatinine = 1.5 x upper limit of normal (ULN)
•Adequate hepatic function, as follows (= 28 d prior to randomization):
oaspartate aminotransferase (ASAT) = 5 x ULN
oalanine aminotransferase (ALAT) = 5 x ULN
ototal 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:
oafter having undergone hysterectomy and/or bilateral ovarectomy
o = 60 years
owith 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

•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 < 14 days prior to randomization
•Concurrent administration of IMP during treatment phase; planned participation in P00 will not be considered as an exclusion criterion
•Concurrent participation in another clinical trial with the same primary endpoint
•Pregnancy, lactation, patients (and patients with partner fulfilling the following criteria) of childbearing potential not willing to use effective means of contraception until six months after completion of study treatment
•Previous irradiation within the actual fields of planned radiotherapy
•Any known hypersensitivity/allergic reaction to any of the components of study treatments
•Any severe and/or uncontrolled medical conditions including but not limited to:
oUnstable angina pectoris, symptomatic congestive heart failure, myocardial infarction = 12 months prior to enrolment, serious uncontrolled cardiac arrhythmia
oAcute and chronic, active infectious disorders and non-malignant medical illnesses that are uncontrolled or whose control may be jeopardized by the complications of this study therapy
oActive skin, mucosa, ocular or GI disorders of Grade > 1
oOther 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified