Resectable pancreatic neuroendocrine tumors MedDRA version: 21.0 Level: LLT Classification code 10067518 Term: Pancreatic neuroendocrine tumor System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Lutathera 370 MBQ/ML- SOLUZIONE PER INFUSIONE- USO ENDOVENOSO- FLACONCINO (VETRO)- 20,5- 25 ML- 1 FLACONCINO
Product Name: Lutathera
Product Code: [Lutezio (177Lu) oxodotreotide]
Pharmaceu
Sponsors
OSPEDALE SAN RAFFAELE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: o Age > 18 years o Morphological confirmation by high-quality imaging technique (MR or CT scan) o Cytological or histologically confirmed sporadic resectable nonfunctioning PanNETs (NF-PanNETs) with positive 68Ga-DOTATOC PET/CT (with primary lesion uptake greater than the normal liver and SUV bw max = 15) and at least one of the following “high-risk features”: o Radiological tumour size > 40 mm o Well differentiated G2 NF-PanNETs with Ki67 >10% or well differentiated NF-PanNETs G3 o Presence of nearby organs involvement o Vascular invasion (excluding the presence of superior mesenteric vein/portal vein invasion > 180° and/or celiac trunk/superior mesenteric artery invasion) o Mesenteric and/or portal and/or splenic vein thrombosis o Presence of a single resectable liver metastasis o Presence of enlarged hypervascularized lymph nodes at imaging that are positive at 68Ga-DOTATOC PET/CT o Absence of extra-abdominal disease o Absence of peritoneal carcinomatosis o Karnofsky Performance Status = 90 or o ECOG-PS=0 o ASA 2,500/ml [ANC> 1,500/mcl]; Hb> 10g/dL; PTL> 100,000/mcl; bilirubin=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: o Age 0 o ASA > 3 o Inadequate bone marrow, liver and kidney function. o Presence of serious disease which can compromise safety (cardiac failure, previous myocardial infarction within prior 6 months, history of psychiatric disabilities, synchronous malignancy) o Bone marrow invasion o Life expectancy less than 6 months o Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product, o Known or suspected non-compliance, drug or alcohol abuse. o Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant, o Participation in another study with investigational drug within the 30 days preceding and during the present study or 5 half-life of the experimental drug. o Enrolment of the investigator, his/her family members, employees and other dependent persons o Creatinine clearance 3 x normal rate o Serum albumin < 3.0 g/dL u o Hb concentration < 5.0 mmol/L (<8.0 g/dL); WBC < 2x10E9/L (2000/mm3); platelets < 75x10E9/L (75x10E3/mm3) o Pregnancy or lactation o Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant are not allowed to participate in this study UNLESS they are using highly effective methods of highly effective contraception (failure rate <1%/year) throughout the study and for 12 months after the administration of the last cycle of 177Lu-DOTATATE (see par. 8.1) o Potential fertile men with female partner of child-bearing potential, during the study period and for at least 1 cycle of spermatogenesis (90 days) after the administration of the last cycle of 177Lu-DOTATATE (see par. 8.1)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main aim of this study is to evaluate the safety of neoadjuvant PRRT with 177Lu-DOTATATE followed by surgical resection for resectable non-functioning PanNETs at high risk of recurrence.;Secondary Objective: The secondary aim is to evaluate the efficacy of neoadjuvant PRRT with 177Lu-DOTATATE.;Primary end point(s): Rate of postoperative 90-day morbidity and mortality after neoadjuvant PRRT with 177Lu-DOTATATE followed by pancreatic resection;Timepoint(s) of evaluation of this end point: 12 week (from week 40 until week 52) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Rate of objective radiological response to PRRT with 177Lu-DOTATATE according to modified RECIST criteria (mRECIST); Quality of life (QoL) after neoadjuvant PRRT followed by pancreatic surgical resection.;Timepoint(s) of evaluation of this end point: at 38th week; Week 0, Week 38, Week 52 | — |
Countries
Italy
Contacts
Public ContactMonitoraggio e dati sulla sicurezza
Pharmaceutical Development and Services srl
Outcome results
None listed