A Study Evaluating Lanreotide as Maintenance Therapy in Patients With Non-Resectable Duodeno-Pancreatic Neuroendocrine Tumors (REMINET) (REMINET)
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| ClinicalTrials.gov Identifier: NCT02288377 |
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Recruitment Status :
Completed
First Posted : November 11, 2014
Last Update Posted : March 30, 2020
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Metastatic/Locally Advanced, Non-resectable, Duodeno-pancreatic Neuroendocrine Tumours | Drug: lanreotide Drug: Placebo | Phase 2 Phase 3 |
This is a European, prospective, multicentre, double-blind randomised study evaluating lanreotide (120 mg every 28 days until disease progression) versus placebo in patients with metastatic/locally advanced, non-resectable, duodeno-pancreatic neuroendocrine tumours.
Depending on the phase II results, the study may be continued into phase III. The treatment and follow-up of patients will be the same in phase II and phase III.
After the first-line treatment, patients will be randomly assigned with a 1:1 ratio to receive either lanreotide or placebo. The study treatment should be initiated within 6 weeks following the confirmation date of stable disease or objective response.
Treatment period:
For each patient, the investigational products (lanreotide or placebo) will be provided according to a double-blind procedure until disease progression or toxicity, in accordance with the protocol.
The estimated average treatment duration for all patients is 12 months.
Follow-up period:
To evaluate overall survival, patients in phase II will have a minimum follow-up period of 12 months; if the study continues to phase III, these patients will have a maximum follow-up period of 10 years. Phase III patients will have a minimum follow-up period of 5 years.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 53 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A EUROPEAN, MULTICENTRE, PHASE II/III RANDOMISED DOUBLE-BLIND, PLACEBO CONTROLLED STUDY EVALUATING LANREOTIDE AS MAINTENANCE THERAPY IN PATIENTS WITH NON-RESECTABLE DUODENO-PANCREATIC NEUROENDOCRINE TUMOURS AFTER FIRST-LINE TREATMENT |
| Actual Study Start Date : | January 2015 |
| Actual Primary Completion Date : | January 2020 |
| Actual Study Completion Date : | January 2020 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: lanreotide
In this arm, patients will receive lanreotide 120 mg every 28 days until disease progression
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Drug: lanreotide
Patients will receive lanreotide 120 mg every 28 days until disease progression |
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Placebo Comparator: placebo
In this arm, patients will receive placebo every 28 days until disease progression
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Drug: Placebo |
- Rate of patients alive and progression free at 6 months [ Time Frame: estimated 6 months after the last patient is randomized ]To evaluate the rate of patients alive and progression free at 6 months, assessed by the investigator according to RECIST criteria (version 1.1)
- Rate of patients alive and progression free at 12 months [ Time Frame: estimated 12 months after the last patient is randomized ]To evaluate the rate of patients alive and progression free at 12 months, assessed by the investigator according to RECIST criteria (version 1.1)
- The toxicities [ Time Frame: estimated 6 months after the last patient is randomized ]Description using the NCI-CTC AE version 4.0
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02288377
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| Principal Investigator: | Come Lepage, Pr | Federation Francophone de Cancerologie Digestive |
| Responsible Party: | Federation Francophone de Cancerologie Digestive |
| ClinicalTrials.gov Identifier: | NCT02288377 |
| Other Study ID Numbers: |
PRODIGE31 |
| First Posted: | November 11, 2014 Key Record Dates |
| Last Update Posted: | March 30, 2020 |
| Last Verified: | March 2020 |
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Lanreotide Duodeno-pancreatic neuroendocrine tumours Maintenance treatment |
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Neuroendocrine Tumors Adenoma, Islet Cell Neoplasms Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms, Nerve Tissue Adenoma Neoplasms, Glandular and Epithelial Pancreatic Neoplasms |
Digestive System Neoplasms Neoplasms by Site Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Lanreotide Angiopeptin Antineoplastic Agents |