177Lutethium - Peptide Receptor Radionuclide Therapy (Lu-PRRT) plus Capecitabine versus Lu-PRRT in FDG positive, gastro-entero-pancreatic neuroendocrine tumors: a randomized phase II study. (Lu-Ca-S)

Phase 1

Active, not recruiting

• Conditions: gastro-entero-pancreatic neuroendocrine tumors (GEP-NET); MedDRA version: 20.0Level: PTClassification code 10052399Term: Neuroendocrine tumourSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-003067-38-IT
• Lead Sponsor: ISTITUTO SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI (IRST) S.R.L. IRCCS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-19
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 176

Inclusion Criteria

1.Histopathologic diagnosis of gastro-entero-pancreatic neuroendocrine tumor, well differentiated G1 – G2 (ki67= 20%) and G3 (ki67= 50%)
2.Male or Female, aged >18 years
3.Measurable disease according to RECIST 1.1 criteria
4.Patients with documented disease will be admitted to therapeutic phase only if the diagnostic receptor imaging, OctreoScan, with a significant uptake in the tumor (grade 2 or 3, according to Rotterdam scale) and/or PET/CT 68Ga-peptide images with a tumor uptake at least equal to liver background
5.Patients with documented disease will be admitted to therapeutic phase only if the 18FDG PET/CT is positive with a SUV > 2.5 at least in one documented lesion.
6.Non operable advanced disease
7.Documented progression after standard therapy such as long acting octreotide or lanreotide (SS-LAR), Everolimus in P-NETs or platinum based therapy in G3 patients.
8.Patients have to finish prior standard chemotherapy or therapeutical radiotherapy (less then 25% body surface) at least 6 weeks

Are the trial subjects under 18? no
Number of subjects for this age range: 1
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 116
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

1.Ki67 index > 50%
2.FDG PET negative
3.Patients treated with chemotherapy and therapeutic radiotherapy within 6 weeks
4.More then 25% body surface radiotherapy
5.Patients treated with previous radiometabolic therapy with an adsorbed dose to the kidney more than 23 Gy and 1,2 Gy for the bone marrow or as surrogate of dosimetry, a Total Cumulative Activity of >250 mCi of 90Y dotatoc or >800 mCi of 177Lu dotatate
6.All acute toxic effects of any prior therapy (including surgery radiation therapy, chemotherapy) must have resolved to a grade = 1 according to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE)
7.Life expectancy minor than 6 months.
8.ECOG performance status >2
9.Participation in another clinical trial with any investigational agents within 30 days prior to study screening.
10.Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
11.History of allergic reactions attributed to compounds of similar chemical or biologic composition
12.Known dihydropyrimidine dehydrogenase (DPD) deficiency.
13.Known hypersensitivity to Octreotide and/or Lanreotide, and/or somatostatin correlate peptides
14.Known hypersensitivity to capecitabine or to any of its components
15.Known hypersensitivity to 5 - fluorouracil.
16.Other known malignant neoplastic diseases in the patient’s medical history with a disease-free interval of less than 5 years (except for previously treated basal cell carcinoma and in situ carcinoma of the uterine cervix);

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: to evaluate the progression free survival (PFS) in the two arms.;Secondary Objective: - the efficacy (disease control rate, DCR)<br>- acute and late toxicity<br>- overall survival (OS).;Primary end point(s): progression free survival (PFS);Timepoint(s) of evaluation of this end point: 7 years

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1) disease control rate (DCR)<br>2) acute and late toxicity<br>3) overall survival (OS);Timepoint(s) of evaluation of this end point: 1) 7 years<br>2) 7 years<br>3) 7 years