Taking people in PolandPhase 3
Tests two radioactive drugs for neuroendocrine gut tumours in adults
Tests two radioactive drugs, LutaPol and ItraPol, in adults with gut neuroendocrine tumours.
Key facts
- Who runs it
- Narodowe Centrum Badan Jadrowych
- Where
- Cracow, Kielce, and Warsaw, PolandSee the 4 sites
- Registry title
- Tandem therapy LutaPol/ltraPol ( I 77Lu / 90Y-DOTATATE) as an effective method in the treatment of neuroendocrine neoplasmas.
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 92 people, planned
- Started
- 11 Jan 2025
- Expected to end
- 15 Sept 2027
- Type of study
- Interventional
- Record updated
- 19 August 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with advanced neuroendocrine tumours of the gut or pancreas that cannot be removed by surgery and have grown. They would get radioactive treatment with 177Lu-DOTATATE and 90Y-DOTATATE.
- Age
- 18 years or older, no upper age limit.
- Sex
- All sexes can join.
- Disease stage
- Advanced neuroendocrine tumour that cannot be removed by surgery, well or intermediate differentiated (G1 and G2), with growth seen on CT or MR scans within 18 months.
- Earlier treatment
- People who had radioactive receptor therapy (PRRT), chemotherapy or molecular treatment in the past cannot join.
- Biomarker or test result
- High amount of somatostatin receptors on a 68Ga-DOTA-TATE PET/CT scan done up to 12 weeks before the first treatment.
Main reasons for not taking part
- Karnofsky score under 60%
- Expected survival of less than 6 months
- Treatment for another cancer less than 5 years ago
- Pregnancy or breastfeeding
- Impaired bladder outflow or untreated urinary incontinence without a catheter
The registry criteria, word for word
Show all 2 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Where in Poland
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W KrakowieCracow, PolandTaking people
- Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej w KielcachKielce, PolandTaking people
- Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut BadawczyWarsaw, PolandTaking people
- Wojskowy Instytut Medyczny Panstwowy Instytut BadawczyWarsaw, PolandTaking people
About the trial
What the trial wants to find out
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.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record
Print a page for my doctorData and sources
- Registry record
- Listed on the EU's official list of trials (CTIS).
- Official title
- Tandem therapy LutaPol/ltraPol ( I 77Lu / 90Y-DOTATATE) as an effective method in the treatment of neuroendocrine neoplasmas.
- Plain-language title
- Tests two radioactive drugs for neuroendocrine gut tumours in adultsGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Record updated
- 19 August 2026