Tandem therapy LutaPol/ltraPol ( I 77Lu / 90Y-DOTATATE) as an effective method in the treatment of neuroendocrine neoplasmas.

Phase 3

Not yet recruiting

Conditions: Diagnosed and histopathologically confirmed diffuse or locally unresectable, well and intermediate differentiated neuroendocrine tumour of the gastrointestinal tract

Registration Number: 2024-516503-17-01

Lead Sponsor: Narodowe Centrum Badan Jadrowych

Brief Summary: The aim of the study is to develop an algorithm for the treatment of GEPNET patients using ItraPol and LutaPol isotope mixtures (177Lu-DOTATATE and 90Y-DOTATATE) based on personalized dosimetry.

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised, recruitment pending

Sex: Not specified

Target Recruitment: 92

Inclusion Criteria

Associated with neuroendocrine tumour: a)Presence of advanced, unresectable, histopathologically confirmed well and intermediate differentiated (G1 and G2) neuroendocrine tumour with high expression of somatostatin receptors on somatostatin receptor imaging (SRI) PET/CT with 68Ga-DOTA-TATE performed up to 12 weeks prior to first administration of therapy b)Detection of tumour progression according to RECIST criteria 1. 1 on multiphasic CT or dynamic MR imaging within 18 months, with a qualifying study performed up to 12 weeks prior to the first administration of therapy c)Laboratory tests*: ◦ Blood count with smear Hb > 9g/dl, platelets > 100,000/μl, leukocytes > 3,000/μl, neutrocytes > 1.5,000/μl, ◦ Creatinine <120 μmol/l (1.36 mg/dl) or eGFR>45 ml/min. ◦ ALT, AspAT, total bilirubin (values not exceeding 3x the reference standard) **it is acceptable to use for qualification the results of biochemical and haematological tests that are part of the medical history if they were performed up to 12 weeks before the qualifying visit and if, in the opinion of the investigator, there is no need and no indication to repeat them Patient-related: Patient's overall Karnofsky score ≥60%. Expected survival of more than 6 months. Age over 18 years, with no upper age limit. Ability to give informed consent to participate in the study. Signing an informed consent form to participate in the study.

Exclusion Criteria

Cancer-related: Patient disability (Karnofsky <60) Expected survival of less than 6 months. Treatment for another malignancy less than 5 years prior to randomisation. Associated with current and past medical therapies and interventions: PRRT in the past. Chemotherapy or molecular treatment (for NEN or other cancer) in the past. Patient-related: Age under 18 years. Pregnancy or breastfeeding. Patients with impaired bladder outflow or untreated urinary incontinence without catheter protection. Lack of capacity to give informed consent to participate in the study. Failure to sign an informed consent form to participate in the study.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease progression assessed by CT or MRI according to RECIST 1.1. Timepoints of Primary End Point evaluation: control imaging investigations (CT or MRI) using the technique identical with the one based on which the patient was qualified for the trial, performed after 3,6,12,24,36,49,60 months after completion of therapy with assessment according to RECIST 1.1		Disease progression assessed by CT or MRI according to RECIST 1.1. Timepoints of Primary End Point evaluation: control imaging investigations (CT or MRI) using the technique identical with the one based on which the patient was qualified for the trial, performed after 3,6,12,24,36,49,60 months after completion of therapy with assessment according to RECIST 1.1

Secondary Outcome Measures

Name	Time	Method
Assessment of effectiveness and safety of personalized therapy. It is planned to perform biochemical tests during visit W1, during hospitalization and in the course of observation every 3 months (tests of blood morphology, urea, creatinine, eGFR, bilirubin). Total volume of blood collected at single timepoint - 6.8 ml.		Assessment of effectiveness and safety of personalized therapy. It is planned to perform biochemical tests during visit W1, during hospitalization and in the course of observation every 3 months (tests of blood morphology, urea, creatinine, eGFR, bilirubin). Total volume of blood collected at single timepoint - 6.8 ml.

Trial Locations

Locations (4): Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach
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Kielce, Poland
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
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Warsaw, Poland
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
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Warsaw, Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
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Cracow, Poland
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach
🇵🇱Kielce, Poland
Alicja Kowalska
Site contact
413674315
badania.kliniczne@onkol.kielce.pl