Primary outcomeCount of participants· 6 months
Proportion of Patients Alive and Progression-free at 6 Months
| Group | Value (Participants) |
|---|---|
| Placebo | 13 |
| Lanreotide | 19 |
Trial · Interventional
TerminatedPhase 2/3Results postedRegistry dataA Study Evaluating Lanreotide as Maintenance Therapy in Patients With Non-Resectable Duodeno-Pancreatic Neuroendocrine Tumors (REMINET)
Short name REMINET
NCTNCT02288377 (opens ClinicalTrials.gov in a new tab)Other idPRODIGE31
This trial was stopped early.
Reason given at the registry: Because of slow recruitment
Results were posted for this trial.
Overview
- Status
- Terminated
- Phase
- Phase 2/3
- Enrollment
- 53 participants (actual)
- Sponsor
- Federation Francophone de Cancerologie Digestive · Other
- Design
- Randomized · Triple masking
- Countries
4 countries
Belgium, France, Germany, United Kingdom
- Start
- Jan 2015
- Primary completion
- Jan 2020
- Completion
- Jan 2020
- First posted
- 11 Nov 2014 (estimated)
- Last update posted
- 18 Jan 2023
- Conditions
- Metastatic/Locally Advanced, Non-resectable, Duodeno-pancreatic Neuroendocrine Tumours
Timeline
1 trial · 1 stopped early · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
2015201620172018201920202021
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This European, prospective, multicentre, double-blind randomised study will evaluate the effect of lanreotide (120 mg every 28 days until disease progression) versus placebo in patients with metastatic/locally advanced, non-resectable, duodeno-pancreatic neuroendocrine tumours.
Interventions
- lanreotideDrug
- PlaceboDrug
Arms2
Experimental
lanreotide
In this arm, patients will receive lanreotide 120 mg every 28 days until disease progression
Placebo comparator
placebo
In this arm, patients will receive placebo every 28 days until disease progression
Primary outcomes1
Outcomes the sponsor listed as primary.
Proportion of Patients Alive and Progression-free at 6 Months
Time frame · 6 months
Registry description
The primary endpoint for this phase II study was the proportion of pts alive and progression-free at 6 months after randomisation, evaluated according to the results of the imaging assessment done by the investigator in line with RECIST 1.1 criteria.
Secondary outcomes(2)
Progression-Free Survival
Time frame · up to 2 years
Registry description
The progression-free survival is the time from inclusion to the first radiological progression or death (all causes). For patients alive without progression date of last news will be considered. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions compared the little sum of diameters observed durin the study (NADIR), or a measurable increase in a nontarget lesion, or the appearance of new lesions
Overall Survival
Time frame · 2 years after the end of the treatment
Registry description
Overall survival considered all deaths, and time was calculated from randomisation to death.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(2)
Secondary outcomeMedian· up to 2 years
Progression-Free Survival
| Group | Value (Months) |
|---|---|
| Placebo | 7.6 |
| Lanreotide | 19.4 |
Secondary outcomeNumber· 2 years after the end of the treatment
Overall Survival
| Group | Value (Percentage of patients alive) |
|---|---|
| Placebo | 86.1 |
| Lanreotide | 95.0 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| PlaceboPatients will receive placebo every 28 days until disease progression | 7 / 25 | 3 / 25 | 6 / 25 |
| LanreotidePatients will receive lanreotide 120 mg every 28 days until disease progression | 2 / 27 | 5 / 27 | 9 / 27 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies2
Studies that cite this trial.
Studies with results
1 study on this page
Indexing hint: Randomized controlled trial · 2022
3 results
Lanreotide as maintenance therapy after first-line treatment in patients with non-resectable duodeno-pancreatic neuroendocrine tumours: An international double-blind, placebo-controlled randomised phase II trial - Prodige 31 REMINET: An FFCD study.
Lepage et al. 2022European journal of cancer (Oxford, England : 1990)cited by 18
PMID 36087395DOI 10.1016/j.ejca.2022.07.033PUB-36087395
Full text at the publisher3 results
More studies
1 study on this page
Indexing hint: Randomized controlled trial · 2017
Evaluating lanreotide as maintenance therapy after first-line treatment in patients with non-resectable duodeno-pancreatic neuroendocrine tumours.
Lepage et al. 2017Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Livercited by 4
PMID 28292641DOI 10.1016/j.dld.2017.02.004PUB-28292641
Full text at the publisher
Other registry references
References listed at the registry that are not in PepBank. They link to PubMed.
- ResultGuiney DG Jr, Hasegawa P, Davis CE. Homology between clindamycin resistance plasmids in Bacteroides. Plasmid. 1984 May;11(3):268-71. doi: 10.1016/0147-619x(84)90035-0. PMID 6087395
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
* Metastatic (synchronous or metachronous) or locally advanced, non-resectable, well-differentiated duodeno-pancreatic neuroendocrine tumour, of grade 1 or 2 (WHO 2010 classification; Ki-67 ≤ 20%)
* Progressive before first-line treatment
* Histologically confirmed (either on primary tumour or metastases)
* Pathological diagnosis validated by the NET consulting pathologist
* Documented stable disease or objective response after first-line treatment, within 4 weeks (28 days) prior to randomisation
* The first-line treatment will consist of either a chemotherapy or biotherapy (everolimus or sunitinib) as referred to TNCD or ENETS guidelines. Treatment must have been administered for 3 to 6 months for chemotherapy and for 6 months for biotherapy
* Non-functional tumour or gastrinoma controlled by PPIs
* Age \> or = 18 years
* WHO 0, 1 or 2
* Effective contraception for male or female patients of childbearing age, defined as: oral contraceptives, intra-uterine devices, barrier contraceptive methods along with a spermicide gel, or surgical sterilisation. Female patients should use this contraception throughout the treatment period and for 6 months after the last treatment administration. Male patients should use contraception throughout the treatment period and for 3 months after the last treatment administration.
* Signed informed consent prior to initiation of any study-specific procedures or treatment.
Exclusion Criteria:
* History of haematological malignancy or other cancer, except those treated for more than 5 years and considered as cured, carcinoma in situ of the cervix and treated skin cancer (excluding melanoma)
* Poorly differentiated neuroendocrine carcinoma or NET grade 3 ENETS (Ki-67 \> 20%)
* If primary resected, bone metastasis exclusively
* Pre-treatment by somatostatin long-acting analogue
* Total bilirubin ≥ 60 µmol/L
* Uncontrolled diabetes
* Contraindication to product used in the study or its components
* Tumour arising in the context of a genetic disease
* Pregnancy or lactation
* Patients unable to undergo medical follow-up due to geographical, social, psychological or legal reasons
* Concomitant participation in another clinical trial investigating a treatment during the treatment phase and within 30 days prior to the start of the study treatment.
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