Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Authorised, recruitment pending
Participants planned
40
Countries
1
Sites
3
Gastroenteropancreatic neuroendocrine tumors
To assess the prognostic value of ⁶⁸Ga-DOTATATE PET performed just before the 3rd injection of ¹⁷⁷Lu-oxodotreotide on progression-free survival.
Key facts
- Sponsor
- Centre De Lutte Contre Le Cancer Eugene Marquis
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Decision date (initial)
- 2026-05-18
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Others
To assess the prognostic value of ⁶⁸Ga-DOTATATE PET performed just before the 3rd injection of ¹⁷⁷Lu-oxodotreotide on progression-free survival.
Secondary objectives 4
- To evaluate the prognostic value of CT performed immediately before the third injection of ¹⁷⁷Lu-oxodotreotide on progression-free survival.
- To assess the agreement between tumor response assessments according to the different PET/CT criteria performed immediately before the third injection of ¹⁷⁷Lu-oxodotreotide.
- To evaluate the inter-observer reproducibility of tumor assessment using visual PET criteria.
- To evaluate the predictive value of ⁶⁸Ga-edotreotide PET performed immediately before the third injection of ¹⁷⁷Lu-oxodotreotide on tumor response at 9 months after treatment initiation.
Conditions and MedDRA coding
Gastroenteropancreatic neuroendocrine tumors
Study design 4 periods
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Pre-treatment period (Screening / Baseline) Patients are reviewed prior to ¹⁷⁷Lu-oxodotréotide administration. Eligibility criteria, medical history, demographic data, baseline laboratory tests, and prior treatments are verified. A first ⁶⁸Ga-edotréotide PET/CT is performed to assess tumor burden before treatment.
|
Not Applicable | None | ||
| 2 | Treatment period Patients receive standard-of-care ¹⁷⁷Lu-oxodotréotide therapy. Before each injection, clinical examination, laboratory tests, recording of adverse events, and concomitant treatments are assessed. Monitoring is aligned with routine clinical care.
|
Not Applicable | None | ||
| 3 | Early response assessment A second ⁶⁸Ga-edotréotide PET/CT is performed after the second injection to evaluate early tumor response. Clinical assessments, laboratory tests, adverse event monitoring, and collection of relevant concomitant treatments continue throughout the treatment period.
|
Not Applicable | None | ||
| 4 | Post-treatment follow-up period After the last ¹⁷⁷Lu-oxodotréotide injection, patients are followed every 3 months until disease progression or a maximum of 36 months from the first injection, whichever occurs first. Evaluations include radiological assessment (contrast-enhanced thoraco-abdomino-pelvic CT scan with RECIST 1.1 criteria), collection of relevant concomitant treatments, and monitoring of adverse events.
|
Not Applicable | None |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- Age ≥ 18 years at the time of signing the informed consent
- Well-differentiated grade 2 metastatic gastroenteropancreatic neuroendocrine tumor (Ki-67 ≥ 3% and ≤ 20%)
- Planned treatment with ¹⁷⁷Lu-oxodotreotide
- ⁶⁸Ga-edotreotide PET/CT performed within 2 months prior to the first injection of ¹⁷⁷Lu-oxodotreotide
- Written informed consent obtained
- Affiliated with or beneficiary of a social security system
Exclusion criteria 3
- Pregnant or breastfeeding women
- Protected persons as defined by the French Public Health Code (Articles L1121-5 to L1121-9 and Article L1122-2-III)
- Hypersensitivity reaction or anaphylactic reaction following the administration of the radiopharmaceutical during PET scan no. 1
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Progression-free survival is defined as the time from the first injection of ¹⁷⁷Lu-oxodotreotide to the occurrence of the first documented tumor progression according to RECIST 1.1 criteria during CT follow-up.
Secondary endpoints 1
- Progression-free survival is defined as the time from the first injection of ¹⁷⁷Lu-oxodotreotide to the occurrence of the first documented tumor progression according to RECIST 1.1 criteria during CT follow-up. Tumor assessment is performed every 3 months after treatment initiation using CT and RECIST 1.1 criteria. ⁶⁸Ga-edotreotide PET/CT images acquired immediately before the third injection of ¹⁷⁷Lu-oxodotreotide will be independently analyzed
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SomaKit TOC 40 micrograms kit for radiopharmaceutical preparation
PRD4592308 · Product
- Active substance
- Edotreotide
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 200 MBq/kg megabecquerel(s)/kilogram
- Max total dose
- 200 MBq/kg megabecquerel(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V09IX09 — -
- Marketing authorisation
- EU/1/16/1141/001
- MA holder
- ADVANCED ACCELERATOR APPLICATIONS
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/15/1450
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- used for prognostic besides diagnosis
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre De Lutte Contre Le Cancer Eugene Marquis
- Sponsor organisation
- Centre De Lutte Contre Le Cancer Eugene Marquis
- Address
- Avenue La Bataille Flandre Dunkerque, Cs 44229 Cs 44229
- City
- Rennes Cedex
- Postcode
- 35042
- Country
- France
Scientific contact point
- Organisation
- Centre De Lutte Contre Le Cancer Eugene Marquis
- Contact name
- Xavier Palard-Novello
Public contact point
- Organisation
- Centre De Lutte Contre Le Cancer Eugene Marquis
- Contact name
- Xavier Palard-Novello
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Authorised, recruitment pending | 40 | 3 |
| Rest of world | — | 0 | — |
Investigational sites
CHU Brest
Department of Molecular Imaging and Radiotheranostic Imaging and Cancerology Institute, Boulevard Tanguy Prigent, 29200, Brest
Centre Eugène Marquis
Médecine Nucléaire, Avenue de la Bataille de Flandres Dunkerque, 35000, Rennes
CHU Nantes
Médecine Nucléaire, 1 Place Alexis Ricordeau, Service de Maladies Infectieuses et Tropicales, Nantes
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 5 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2025-524942-87-00 | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | RCP SomaKit TOC | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_FR_2025-524942-87-00 | 2.0 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-01-28 | France | Acceptable 2026-05-11
|
2026-05-18 |