Prospective Randomized Multicenter Phase II Trial toInvestigate Intensified Neoadjuvant Chemotherapy inLocally Advanced Pancreatic Cancer
- Conditions
- ocally advanced pancreatic cancerMedDRA version: 21.0Level: LLTClassification code 10033604Term: Pancreatic cancerSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2013-004796-12-DE
- Lead Sponsor
- AIO-Studien-gGmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 168
- Adult patients = 18 years and = 75 years of age
- Histologic or cytologic proven ductal adenocarcinoma of the
pancreas (histologic confirmation of diagnosis is preferred)
- No distant metastases
- De novo, treatment-nai¨ve unresectable or borderline resectable
LAPC; evaluation of unresectable and borderline resectable status
based on recommendations in NCCN- Clinical Practice Guidelines in Oncology
pancreatic adenocarcinoma” version 1.2015. Applicable
criterion/criteria have to be indicated.
- Eastern Cooperative Oncology Group (ECOG) performance status
0 or 1
- Total bilirubin = 2 mg/dL. Patients with a biliary stent may be
included provided that bilirubin level after stent insertion
decreased to = 2 mg/dL and there is no cholangitis.
- Adequate renal, hepatic and bone marrow function
? Calculated creatinine clearance = 60 mL/min
according to CKD-EPI formula
? AST/GOT and/or ALT/GPT = 3.0 x ULN
? PTT = 1.5 x ULN and Quick value = 70%
? Absolute neutrophil count (ANC) = 1.5 x 109/L
? Haemoglobin = 8g/dL
? Platelets = 100 x 109/L
- Females of childbearing potential (FCBP) must have a negative
pregnancy test within 7 days of the first application of study
treatment and must agree to use effective contraceptive birth control measures (Pearl Index < 1) during the course of the trial and for at least 1 month after last application of study treatment.
A female subject is considered to be of childbearing potential
unless she is age = 50 years and naturally amenorrhoeic for = 2
year, or unless she is surgically sterile.
- Males must agree not to father a child during the course of the trial
and for at least 6 months after last administration of study drugs.
- Signed and dated informed consent before the start of any specific
protocol procedures
- Patient’s legal capacity to consent to study participation
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 168
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 168
- Evidence of distant metastases. In case of radiological suspicion of
peritoneal carcinomatosis or ascites histological or cytological
verification is required e.g. by means of exploratory laparoscopy
- Local relapse of the pancreatic adenocarcinoma prior treated with
surgical resection
- Any previous treatment of the pancreatic carcinoma
- Contraindication for pancreas resection
- Larger surgical interventions within 4 weeks before study
enrolment and/or diagnostic laparotomy with or without
gastroenterostomy and with or without biliodigestive anastomosis
within 2 weeks before first application of study treatment. Wound
healing must be also completed before first application of study
treatment.
- Known chronic diarrhoea
- Peripheral polyneuropathy > grade 1
- Known dihydropyrimidine dehydrogenase (DPD) deficiency
- Medical history of interstitial lung disease (ILD) or pulmonary
fibrosis
- Hypersensitivity against any of the study drugs (nab-paclitaxel,
gemcitabine, oxaliplatin, irinotecan, 5-fluorouracil, folinic acid),
or the ingredients of these drugs
- Active or uncontrolled bacterial, viral, or fungal infection that
requires systemic treatment
- Known HIV- infection or active HBV- or HCV –infection
- Convulsion disorder that requires anticonvulsive treatment
- Clinically significant cardiovascular or vascular disease or
disorder = 6 months before study enrolment (e.g. myocardial
infarction, unstable angina pectoris, chronic heart failure NYHA =
grade 2, uncontrolled arrhythmia, cerebral infarction)
- Any other severe concomitant disease or disorder, which could
influence patient’s ability to participate in the study and his/her
safety during the study or interfere with interpretation of study
results e.g. severe hepatic, renal, pulmonary, metabolic, or
psychiatric disorders
- Requirement for concomitant antiviral treatment with sorivudine
or brivudine
- Requirement of immunosuppressive treatment
- Continuing anticoagulant therapy with coumarin derivatives
(treatment with low-molecular weight heparin allowed)
- Continuing abuse of alcohol, drugs, or medical drugs
- Pregnant or breast feeding females
- Participation in any other clinical trial or treatment with any
experimental drug within 28 days before enrolment to the study or
during study participation until the end of treatment visit.
- Previous or concurrent malignant tumor disease other than
underlying tumor disease with the exception of cervical cancer in
situ, adequately treated basal cell carcinoma or squamous cell
carcinoma of the skin, superficial bladder tumors (Ta,Tis, and T1)
or any curatively treated tumors > 5 years prior to enrolment
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method