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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.
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 18 Years and Over |
Gender | All |
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT06878664 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 3 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Grupo Espanol de Tumores Neuroendocrinos |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Rocio Garcia Carbonero Garcia Carbonero, M.D., Ph.D.Eric Baudin Baudin, M.D., Ph.D. |
Principal Investigator Affiliation | Hospital Universitario 12 de OctubreGustave Roussy, Cancer Campus, Grand Paris |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Other |
Overall Status | Not yet recruiting |
Countries | France, Spain |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Grade1-2 Advanced Midgut Neuroendocrine Tumors (NETs) |
1. Rationale The main hypothesis is 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. 2. Objectives Primary Objectives. -To demonstrate decreased serious hematological toxicity with a less intensive RLT regimen in slowly progressive advanced Grade 1-2 midgut NETs. Secondary Objectives.
Experimental: 177Lu-Dotatate every 16 weeks
Experimental arm: 1. Treatment with 177Lu-Dotatate (7.4 Gigabecquerel/cycle) during 30 min intravenous infusion every 16 weeks (q16w) x 4 cycles 2. Renal protection starting 30 minutes before targeted radioligand therapy (RLT) lasting 4 hours (iv amino acid solution of 14.4-20g of lysine and 14.9-20.7g of arginine in 1 to 2 liters of solution) 3. Long-acting standard doses of SSA (Lanreotide autogel 120 mg subcutaneous or Octreotide LAR 30 mg intramuscular, starting 24h after RLT 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.
Active Comparator: 177Lu-Dotatate every 8 weeks
1. Treatment with 177Lu-Dotatate (7.4 Gigabecquerel/cycle) during 30 min intravenous infusion every 8 weeks (q8w) x 4 cycles 2. Renal protection starting 30 minutes before targeted radioligand therapy (RLT) lasting 4 hours (iv amino acid solution of 14.4-20g of lysine and 14.9-20.7g of arginine in 1 to 2 liters of solution); 3. Long-acting standard doses of SSA (Lanreotide autogel 120 mg subcutaneous or Octreotide LAR 30 mg intramuscular, starting 24h after RLT every 4 weeks during RLT (q8w 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
Drug: - 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.
Drug: - 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.
Drug: - 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)
Drug: - 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.
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
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Hopital BEAUJON
Clichy, Paris, 92110
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A responsible person Selected by Sponsor,, M.D., Ph.D.
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Centre François BACLESSE
Caen, , 14000
Site Contact
A responsible person Selected by Sponsor,, M.D., Ph.D.
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Chu Dijon
Dijon, , 21000
Site Contact
A responsible person Selected by Sponsor,, M.D., Ph.D.
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Hospital Center University De Lille
Lille, , 59000
Site Contact
A responsible person Selected by Sponsor,, M.D., Ph.D.
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Hospices civiles de Lyon
Lyon, , 69002
Site Contact
A responsible person Selected by Sponsor,, M.D., Ph.D.
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Institut Paoli Calmette
Marseille, , 13009
Site Contact
A responsible person Selected by Sponsor,, M.D., Ph.D.
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Hopital COCHIN
Paris, , 75014
Site Contact
A responsible person Selected by Sponsor,, M.D., Ph.D.
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Centre Eugène MARQUIS
Rennes, , 35000
Site Contact
A responsible person Selected by Sponsor,, M.D., Ph.D.
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Hospital Universitario Central de Asturias
Oviedo, Asturias, 33011
Site Contact
A responsible person Selected by Sponsor,, M.D., Ph.D.
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Hospital Universitario de Burgos
Burgos, Baleares, 09006
Site Contact
A responsible person Selected by Sponsor,, M.D., Ph.D.
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Instituto Catalán de Oncología - Hospital Duran i Reynals
L'Hospitalet de Llobregat, Barcelona, 08908
Site Contact
A responsible person Selected by Sponsor,, M.D., Ph.D.
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Complexo Hospitalario Universitario de Santiago
Santiago de Compostela, La Coruña, 15706
Site Contact
A responsible person Selected by Sponsor,, M.D., Ph.D.
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Hospital Universitari Vall d'Hebrón
Barcelona, , 08035
Site Contact
A responsible person Selected by Sponsor,, M.D., Ph.D.
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Hospital Virgen de las Nieves de Granada
Granada, , 18014
Site Contact
A responsible person Selected by Sponsor,, M.D., Ph.D.
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Hospital General Universitario Gregorio Marañón
Madrid, , 28007
Site Contact
A responsible person Selected by Sponsor,, M.D., Ph.D.
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Hospital Universitario Ramón y Cajal
Madrid, , 28034
Site Contact
A responsible person Selected by Sponsor,, M.D., Ph.D.
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Hospital 12 de Octubre
Madrid, , 28041
Site Contact
Investigator Selected Selected by Sponsor,, M.D., Ph.D.
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Hospital Universitario La Paz
Madrid, , 28046
Site Contact
A responsible person Selected by Sponsor,, M.D., Ph.D.
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Hospital Universitario Virgen del Rocío
Sevilla, , 41013
Site Contact
A responsible person Selected by Sponsor,, M.D., Ph.D.
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Hospital Clínico de Valencia
Valencia, , 46010
Site Contact
A responsible person Selected by Sponsor,, M.D., Ph.D.
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Hospital Universitario y Politécnico La Fe
Valencia, , 46026
Site Contact
A responsible person Selected by Sponsor,, M.D., Ph.D.