Randomized Interval Assessment Trial of Lu177-Dotatate in Slowly Progressive G1-2 Advanced Midgut Neuroendocrine Tumors
Condition(s) studied
Investigational drug(s) / intervention(s)
177Lu-Dotatate (7.4 Gigabecquerel/cycle) during 30 min intravenous infusion every 16 weeks (q8w) x 4 cycles; 2) and 3) as in the experimental arm.: Treatment with 177Lu-Dotatate (7.4 Gigabecquerel/cycle) during 30 min intravenous infusion every 16 weeks 177Lu-Dotatate, a radiopharmaceutical medicine which is an somatostatin analogue derived from octreotide that complexes via DOTA with non-carrier added (n.c.a) 177Lu radioconjugate. 177Lu-Dotatate will be supplied as a 370 MBq/mL solution for infusion. One mL of solution contains 370 MBq The total amount of radioactivity per single-dose vial is 7 400 MBq at the date and time of infusion. Given the fixed volumetric activity of 370 MBq/mL at the date and time of calibration, the volume of the solution in the vial ranges between 20.5 and 25.0 mL in order to provide the required amount of radioactivity at the date and time of infusion of lutetium (177Lu) oxodotreotide at the date and time of calibration.
177Lu-Dotatate (7.4 Gigabecquerel/cycle) during 30 min intravenous infusion every 8 weeks (q8w) x 4 cycles; 2) and 3) as in the experimental arm.: Treatment with 177Lu-Dotatate (7.4 Gigabecquerel/cycle) during 30 min intravenous infusion every 8 weeks (q8w) x 4 cycles 177Lu-Dotatate, a radiopharmaceutical medicine which is an somatostatin analogue derived from octreotide that complexes via DOTA with non-carrier added (n.c.a) 177Lu radioconjugate. Synonyms are: 177Lu-DOTA0-Tyr 3-Octreotate, 177Lu-DOTATE LUTATHERA, lutetium (177Lu) oxodotreotide 177Lu-Dotatate will be supplied as a 370 MBq/mL solution for infusion One mL of solution contains 370 MBq The total amount of radioactivity per single-dose vial is 7 400 MBq at the date and time of infusion. Given the fixed volumetric activity of 370 MBq/mL at the date and time of calibration, the volume of the solution in the vial ranges between 20.5 and 25.0 mL in order to provide the required amount of radioactivity at the date and time of infusion of lutetium (177Lu) oxodotreotide at the date and time of calibration.
Amino acid solution: Renal protection starting 30 minutes before RLT and lasting 4 hours (iv) amino acid solution of 14.4-20 g of lysine and 14.9-20.7 g of arginine in 1 to 2 liters of solution)
Lanreotide (Autogel formulation) or Octreotide LAR: Long-acting standard doses of SSA (Lanreotide autogel 120 mg subcutaneous (sc) or Octreotide LAR 30 mg im, starting 24h after RLT and every 4 weeks during RLT (q16w interval SSA administration should be adjusted to RLT administrations so that SSA is always given 24h after each RLT dose and at least 4 weeks prior to next RLT administration cycle) and q4w following last RLT administration until disease progression.
Study summary
This is a randomized Phase II/late phase I de-escalation clinical trial with approved investigational medicinal products in new use condition, low intervention.
Disease under study Patients with unresectable or metastatic, slowly progressive, well-differentiated (Grade1 and Grade2), somatostatin receptor-positive midgut neuroendocrine tumors (GEP-NETs).
It is planned to randomize 166 patients with a histologically confirmed diagnosis of slowly progressive grade 1 or grade 2 advanced midgut neuroendocrine tumors (NETs) candidates to receive 177Lu-Dotatate targeted radioligand therapy (RLT). Patients are required to have SSTR+ disease, as evidenced on somatostatin receptor imaging. Patients will be randomized into two arms:
1. control arm: regimen 177Lu-Dotatate every 8 weeks (q8w)
2. experimental arm: regimen 177Lu-Dotatate every 16 weeks (q16w)
Research hypothesis: Less intensive somatostatin-receptor (SST) targeted radioligand therapy (RLT) (7.4 GBq/cycle 177Lu-Dotatate every 16 weeks x 4 cycles) is associated with less severe hematological toxicities and may mitigate the risk to develop therapy-related myeloid neoplasms (t-MN) with similar antitumor efficacy in slowly growing gastrointestinal grade 1-2 NETs.
Eligibility
Primary outcome measure(s)
- Rate of Grade 2-5 hematological toxicity — Throughout the study period, from initiation of treatment with RLT up to 24 months
The primary endpoint for the RIALTO trial is the frequency of Grade 2-5 hematological toxicity (worst per patient) from initiation of treatment with RLT up to 24 months thereafter according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5 (NCI-CTCAE v5)
Trial sites (21)
| Facility | City | Region | Status |
|---|---|---|---|
| Centre François BACLESSE | Caen | Caen | Recruiting |
| Chu Dijon | Dijon | Dijon | Recruiting |
| Hospital Center University De Lille | Lille | Lille | Recruiting |
| Hospices Civiles de Lyon | Lyon | Lyon | Recruiting |
| Institut Paoli Calmette | Marseille | Marseille | Not Yet Recruiting |
| Hopital BEAUJON | Clichy | Paris | Recruiting |
| Hopital COCHIN | Paris | Paris | Recruiting |
| Institute Gustave Roussy | Villejuif | Paris | Recruiting |
| Centre Eugène MARQUIS | Rennes | Rennes | Not Yet Recruiting |
| Hospital Universitari Vall d'Hebrón | Barcelona | Barcelona | Recruiting |
| Instituto Catalán de Oncología - Hospital Duran i Reynals | L'Hospitalet de Llobregat | Barcelona | Recruiting |
| Hospital Universitario de Burgos | Burgos | Castille and León | Recruiting |
| Hospital Virgen de las Nieves de Granada | Granada | Granada | Recruiting |
| Hospital General Universitario Gregorio Marañón | Madrid | Madrid | Recruiting |
| Hospital Universitario Ramón y Cajal | Madrid | Madrid | Recruiting |
| Hospital 12 de Octubre | Madrid | Madrid | Recruiting |
| Hospital Universitario La Paz | Madrid | Madrid | Recruiting |
| Hospital Universitario Central de Asturias | Oviedo | Principality of Asturias | Recruiting |
| Hospital Universitario Virgen del Rocío | Seville | Sevilla | Recruiting |
| Hospital Clínico de Valencia | Valencia | Valencia | Recruiting |
| Hospital Universitario y Politécnico La Fe | Valencia | Valencia | Recruiting |
More Grupo Espanol de Tumores Neuroendocrinos trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06878664 on ClinicalTrials.gov ↗ ← All trials in France