Application of radioisotope therapy as an effective method in the treatmentof neuroendocrine neoplasms

Phase 1

• Conditions: Diagnosed and confirmed histopathologically disseminated or locally unresectable, well and moderately differentiated (G1 and G2) neuroendocrine neoplasms of the gastrointestinal tract (GEP-NET); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2020-006068-99-PL
• Lead Sponsor: arodowe Centrum Badan Jadrowych, Osrodek Radioizotopów POLATOM

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-27
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

I. Related to the neuroendocrine tumor
a)advanced, unresectable, confirmed in histopathological test, well and moderately differentiated (G1 and G2) neuroendocrine neoplasms, in which high expression of somatostatin receptors have been confirmed by Somatostatin Receptor Imaging (SRI) in PET/CT using 68Ga-DOTA-TATE, which has been performed not earlier than 12 weeks prior to qualification.
b)disease progression according to RECIST 1.1 criteria diagnosed in multiphase CT or dynamic MRI within 18 months, given the qualification investigation is performed not earlier than 12 weeks prior to qualification.
c)Laboratory test:
? morphology with smear Hb > 9g/dl, platelets > 100 tys./µl, leukocytes > 3 k/µl, neutrocytes > 1,5 k/µl,
? creatinine <120 µmol/l (1,36 mg/dl), eGFR>45 ml/min.
? AlAT, AspAT, total bilirubin (values not higher than 3x reference standard)
II.Related to the patient
Overall status of the patient in Karnofsky’s scale =60%. Expected life span over 6 months. Age over 18 years, no age limit in adults. Ability to express informed consent to take part in the trial.

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 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 62

Exclusion Criteria

I. Related to the neuroendocrine tumor
Disability of the patient (Karnofsky <60)
Expected life span below 6 months
Anther malignant neoplastic disease treatment within 5 years prior to randomization
Related to current therapies and medical interventions or those in the past
Earlier PRRT
Chemotherapy or molecular therapy (due to NEN or another neoplasm) in the past
II.Related to the patient
Age less than 18 years
Pregnancy or breast feeding
Patients with urinary flow disorders or with non-treated urinary incontinence without catheter protection.
Disability to express informed consent to take part in the trial.
Unsigned informed consent form for taking part in the trial.

Study & Design

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