Actively Recruiting
Randomized Interval Assessment Trial of Lu177-Dotatate in Slowly Progressive G1-2 Advanced Midgut Neuroendocrine Tumors
Led by Grupo Espanol de Tumores Neuroendocrinos · Updated on 2025-09-02
166
Participants Needed
21
Research Sites
185 weeks
Total Duration
On this page
Sponsors
G
Grupo Espanol de Tumores Neuroendocrinos
Lead Sponsor
G
Grupo Español de Tumores Neuroendocrinos y Endocrinos (GETNE)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Randomized Interval Assessment Trial of Lu177-Dotatate in Slowly Progressive G1-2 Advanced Midgut Neuroendocrine Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed diagnosis of unresectable, advanced or metastatic midgut NETs (jejunum-ileum or right colon) eligible for 177Lu-Dotatate therapy
- Ki-67 index less than or equal to 20%
- Disease progression within 36 months before study entry per RECIST v1.1
- Treatment naive or previously treated except no prior radioligand therapy
- All target and non-target lesions positive on somatostatin receptor imaging
- Measurable disease by RECIST v1.1 criteria
- Adequate hematological, renal, and liver function meeting specified lab values
- Karnofsky performance status of 70% or higher
- Signed informed consent and ability to comply with study procedures
- Age 18 years or older
- Recovery to Grade 1 or less from any prior treatment adverse events (excluding alopecia or asthenia)
- Life expectancy of at least 12 months
- Health coverage including clinical trial treatments and procedures
- Female participants with negative pregnancy test and agreement to use effective contraception
- Male participants agree to use condoms during study and 7 months after last treatment
- Agreement not to participate in another interventional study during treatment
You will not qualify if you...
- Known allergy to lutetium-177, oxodotreotide, DOTA, somatostatin analogues, lysine, arginine, or related agents
- Prior external beam radiation therapy to over 25% of bone marrow
- Prior whole liver internal radiation therapy
- Any prior radioligand therapy
- Major surgery, systemic therapy, embolization, or locoregional treatment within 4 weeks before study
- Active Hepatitis B or C infection or known HIV infection
- Other cancers unless cured and no recurrence for 3 years
- Serious non-cancer diseases interfering with study or safety
- Female patients unwilling to avoid breastfeeding or egg donation during and 7 months after study
- Male patients unwilling to avoid sperm donation during and 4 months after study
- Pregnancy or lactation
- Patients or partners not agreeing to use highly effective contraception during and 7 months after treatment
- Patients unable to give informed consent or under legal guardianship or deprived of liberty
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 21 locations
1
Centre François BACLESSE
Caen, Caen, France, 14000
Not Yet Recruiting
2
Chu Dijon
Dijon, Dijon, France, 21000
Not Yet Recruiting
3
Hospital Center University De Lille
Lille, Lille, France, 59000
Not Yet Recruiting
4
Hospices civiles de Lyon
Lyon, Lyon, France, 69002
Not Yet Recruiting
5
Institut Paoli Calmette
Marseille, Marseille, France, 13009
Not Yet Recruiting
6
Hopital BEAUJON
Clichy, Paris, France, 92110
Not Yet Recruiting
7
Hopital COCHIN
Paris, Paris, France, 75014
Not Yet Recruiting
8
Centre Eugène MARQUIS
Rennes, Rennes, France, 35000
Not Yet Recruiting
9
Hospital Universitario de Burgos
Burgos, Balearic Islands, Spain, 09006
Actively Recruiting
10
Hospital Universitari Vall d'Hebrón
Barcelona, Barcelona, Spain, 08035
Actively Recruiting
11
Instituto Catalán de Oncología - Hospital Duran i Reynals
L'Hospitalet de Llobregat, Barcelona, Spain, 08908
Actively Recruiting
12
Hospital Virgen de las Nieves de Granada
Granada, Granada, Spain, 18014
Actively Recruiting
13
Complexo Hospitalario Universitario de Santiago
Santiago de Compostela, La Coruña, Spain, 15706
Not Yet Recruiting
14
Hospital General Universitario Gregorio Marañón
Madrid, Madrid, Spain, 28007
Not Yet Recruiting
15
Hospital Universitario Ramón y Cajal
Madrid, Madrid, Spain, 28034
Actively Recruiting
16
Hospital 12 de Octubre
Madrid, Madrid, Spain, 28041
Actively Recruiting
17
Hospital Universitario La Paz
Madrid, Madrid, Spain, 28046
Not Yet Recruiting
18
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, Spain, 33011
Not Yet Recruiting
19
Hospital Universitario Virgen del Rocío
Seville, Sevilla, Spain, 41013
Not Yet Recruiting
20
Hospital Clínico de Valencia
Valencia, Valencia, Spain, 46010
Actively Recruiting
21
Hospital Universitario y Politécnico La Fe
Valencia, Valencia, Spain, 46026
Actively Recruiting
Research Team
A
A responsible person designated by the sponsor
CONTACT
R
Responsible person designated by the sponsor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here