Tandem therapy LutaPol/ltraPol ( I 77Lu / 90Y-DOTATATE) as an effective method in the treatment of neuroendocrine neoplasmas.
Key facts
- Where
- Cracow, Kielce és Warsaw, LengyelországSee the 4 sites
- Phase
- 3. fázis
Where in Lengyelország
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W KrakowieCracow, LengyelországToborzás még nem indult
- Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej w KielcachKielce, LengyelországToborzás még nem indult
- Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut BadawczyWarsaw, LengyelországToborzás még nem indult
- Wojskowy Instytut Medyczny Panstwowy Instytut BadawczyWarsaw, LengyelországToborzás még nem indult
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?
Trial details
- Who runs it
- Narodowe Centrum Badan Jadrowych
- Trial code
- EU 2024-516503-17-01
- Record updated
- 2026. augusztus 19.
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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: 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.