Status:
COMPLETED
Neoadjuvant PRRT With 177Lu-DOTATATE Followed by Surgery for Resectable PanNET
Lead Sponsor:
IRCCS San Raffaele
Conditions:
Neuroendocrine Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Peptide Receptor Radionuclide Therapy (PRRT) is based on specific somatostatin receptor targeting with radiolabelled analogues 90Y-DOTATOC and 177Lu-DOTATATE. These two most commonly used radiopeptide...
Detailed Description
Rationale: In a recent study un initial experience was reported with neoadjuvant PRRT followed by surgical resection in patients affected by PanNETs. In this study, patients with resectable or potent...
Eligibility Criteria
Inclusion
- Age \> 18 years
- Morphological confirmation by high-quality imaging technique (MR or CT scan)
- 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:
- Radiological tumour size \> 40 mm
- Well differentiated G2 NF-PanNETs with Ki67 \>10% or well differentiated NF-PanNETs G3
- Presence of nearby organs involvement
- Vascular invasion (excluding the presence of superior mesenteric vein/portal vein invasion \> 180° and/or celiac trunk/superior mesenteric artery invasion)
- Mesenteric and/or portal and/or splenic vein thrombosis
- Presence of a single resectable liver metastasis
- Presence of enlarged hypervascularized lymph nodes at imaging that are positive at 68Ga-DOTATOC PET/CT
- Absence of extra-abdominal disease
- Absence of peritoneal carcinomatosis
- Karnofsky Performance Status ≥ 90 or o ECOG-PS=0
- ASA ≤ 3
- Preserved hematologic, hepatic and renal parameters (WBC\> 2,500/ml \[ANC\> 1,500/mcl\]; Hb\> 10g/dL; PTL\> 100,000/mcl; bilirubin\< 2.5 mg/dl, creatinine\< 2 mg/dl)
- Absence of serious disease which can compromise safety (cardiac failure, previous myocardial infarction within prior 6 months, history of psychiatric disabilities, synchronous malignancy)
Exclusion
- Age \< 18 years
- Negative functional Imaging (68Ga-DOTATOC PET/CT)
- Presence of genetic syndrome (MEN1, VHL, NF)
- Functioning PanNET
- NF-PanNEC G3
- Absence of "high-risk features" as defined above
- Presence of extra abdominal disease
- Presence of multiple liver metastases
- Presence of peritoneal carcinomatosis
- Previous PanNET-directed treatment
- Karnofsky Performance Status \< 90% or ECOG-PS \> 0
- ASA \> 3
- Inadequate bone marrow, liver and kidney function
- Presence of serious disease which can compromise safety (cardiac failure, previous myocardial infarction within prior 6 months, history of psychiatric disabilities, synchronous malignancy)
- Bone marrow invasion
- Life expectancy less than 6 months
- Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product,
- Known or suspected non-compliance, drug or alcohol abuse
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
- 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
- Enrolment of the investigator, his/her family members, employees and other dependent persons
- Creatinine clearance \< 30 mL/min calculated by the Cockroft Gault method
- Uncontrolled congestive heart failure (NYHA III, IV).
- Total bilirubin \> 3 x normal rate
- Serum albumin \< 3.0 g/dL u
- Hb concentration \< 5.0 mmol/L (\<8.0 g/dL); WBC \< 2x10E9/L (2000/mm3); platelets \< 75x10E9/L (75x10E3/mm3)
- Pregnancy or lactation
Key Trial Info
Start Date :
March 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 26 2023
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT04385992
Start Date
March 9 2020
End Date
June 26 2023
Last Update
June 27 2023
Active Locations (1)
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1
Ospedale San Raffaele
Milan, Italy, 20132