Actively Recruiting
Receptor Radionuclide Therapy With 177Lu-DOTATOC (177Lu-edotreotide or 177Lu-octreotide) in SSTR Positive Patients: a Multicenter, Prospective, Phase II Trial
Led by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS · Updated on 2024-08-13
100
Participants Needed
2
Research Sites
99 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial studies neuroendocrine tumors, paraganglioma, pheochromocytoma, and other SSTR-positive tumors that are not currently approved for lutetium therapy called LUTATHERA. It aims to evaluate the effectiveness and safety of a similar treatment called lutetium (177Lu) edotreotide or 177Lu-DOTATOC in patients who have these diseases but are outside the standard indications for LUTATHERA. The study focuses on expanding knowledge about this therapy's role in controlling disease and managing side effects. Participants receive treatment with 177Lu-DOTATOC given by slow intravenous infusion over 30 minutes using a pump system. The dose depends on patient risk factors: those with fewer than two risk factors receive 7.4 GBq per cycle, while those with two or more risk factors receive 5.5 GBq per cycle. Each participant will receive 4 cycles of treatment. Risk factors include kidney impairment, previous toxicities, uncontrolled diabetes or hypertension, prior therapies, and disease burden. During the study, participants will have regular assessments over several months, including scans to measure disease control at 32 months and ongoing monitoring up to 44 months for progression-free survival, overall survival, safety, and quality of life. Researchers will check blood tests, organ function, and side effects. This non-randomized phase 2 study allows patients with measurable or evaluable disease and progressive tumors confirmed by imaging to be included, with follow-up to evaluate response and safety.
CONDITIONS
Brief Title
"Receptor Radionuclide Therapy With 177Lu-DOTATOC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histological or cytological confirmation of neuroendocrine tumors or other tumor types positive for somatostatin receptor 2 (sst2) that may benefit from receptor radionuclide therapy
- Measurable or evaluable disease according to RECIST 1.1 criteria
- Any disease stage with significant uptake (Grade 3 or 4) in most lesions on PET/CT imaging
- Progressive disease within the last 12 months despite standard treatments
- With or without concurrent somatostatin analog therapy at stable dose
- Life expectancy greater than 6 months
- ECOG performance status less than 2
- Adequate blood counts, liver and kidney function meeting specified thresholds
- For women of childbearing potential, use of highly effective birth control methods during and for 6 months after treatment
- Willing and able to provide informed consent
You will not qualify if you...
- Chemotherapy or therapeutic radiotherapy within 4 weeks, palliative radiotherapy within 2 weeks, or recent hormonal/biological therapy
- Known allergy to lutetium-177, edotreotide, DOTA, or related compounds
- Allergy to lysine, arginine, or nephroprotective amino acids used with treatment
- Prior external beam radiation to over 25% of bone marrow
- Previous PRRT exceeding dose limits to kidney or bone marrow
- Patients eligible for LUTATHERA treatment
- Unresolved acute toxicities from prior therapies above grade 1
- ECOG performance status greater than 2
- Participation in another investigational trial within 30 days
- Uncontrolled illnesses such as infections, heart failure, unstable angina, arrhythmias, or psychiatric/social issues limiting compliance
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of 4 treatment cycles
Participants receive 4 cycles of receptor radionuclide therapy with 177Lu-DOTATOC through slow intravenous infusion over 30 minutes per cycle. Dose depends on individual risk factors.
4 infusions with associated visits
Duration - Up to 44 months following treatment
Participants are monitored for safety, disease control, progression, survival, and quality of life after treatment completion.
Scheduled follow-up visits over months
Trial Site Locations
Total: 2 locations
1
AUSL Romagna - Ospedale "M. Bufalini"
Cesena, Forlì-Cesena, Italy, 47521
Not Yet Recruiting
2
IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l.
Meldola, Forlì-Cesena, Italy, 47014
Actively Recruiting
Research Team
O
Oriana Nanni
B
Bernadette Vertogen
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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