Neuroendocrine TumorsPhase 3SEQTORNCT02246127
Sequentiality of Everolimus and STZ-5FU in Advanced Pancreatic Neuroendocrine Tumor
A Phase 3 study testing Drug: Everolimus and STZ-5FU in people with Neuroendocrine Tumors, run by Grupo Espanol de Tumores Neuroendocrinos at 37 sites in 8 countries.
Trial summary
The purpose of this study is to compare streptozotocin (STZ) vs everolimus as first line treatment for advanced pNET and to elucidate which sequence of STZ based chemotherapy and the mammalian Target of Rapamycin (mTOR) inhibitor, everolimus, gives better results in terms of second Progression Free Survival (PFS) in… Read more about this study
- Who is it for?
- Ages 18 to 94 years
- Conditions the study is for
- Neuroendocrine Tumors
- What is being tested?
- Drug: Everolimus and STZ-5FU
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 37 sitesin 8 countries
- Study dates
- 27 Oct 2014to 12 Jul 2021
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 94 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven diagnosis of unresectable or metastatic, advanced pancreatic NET.
- Documented confirmation of pancreatic NET G1 or G2 as per European Neuroendocrine Society (ENETS) classification system.
- Patients from whom a paraffin-embedded primary tumour or metastasis block is available and to be sent by Courier.
- Before study inclusion, patients must show progressive disease documented by radiology 12 months prior to study inclusion. Treatment naive patients can be also included if the patient needs active treatment with either chemotherapy or everolimus.
- Presence of measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.0, documented by a Triphasic Computed Tomography (CT) scan or multiphase MRI radiological assessment.
- Previous treatment with somatostatin (SS) analogues is allowed. Only those patients with active functioning syndrome at entry can continue with SS analogues during the study.
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- Adequate bone marrow and renal functions, and serum fasting cholesterol
- Women with child-bearing potential must have a negative serum pregnancy test.
- Written Informed Consent obtained according to local regulations
Who cannot join
- Previous treatment with chemotherapy and/or mTOR inhibitors or tyrosine kinase inhibitors.
- Immune therapy or radiation therapy within 4 weeks prior to the patient entering the study.
- Hepatic artery embolization within the last 6 months (1 month if there are other sites of measurable disease), or cryoablation/radiofrequency ablation of hepatic metastasis within 2 months of enrolment.
- Previous treatment with Peptide-Receptor Radionuclide Therapy (PRRT) within the last 6 months and/or without progression following PRRT.
- Uncontrolled diabetes mellitus.
- Any severe and/or uncontrolled medical conditions.
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- Treatment with potent inhibitors or inducers of Cytochrome P450 3A4 (CYP3A) isoenzyme within 5 days immediately before the start of treatment.
- Patients on chronic treatment with corticosteroids or any other immunosuppressive agent.
- Patients known to be HIV seropositive.
- Known intolerance or hypersensitivity to everolimus or its excipients or other rapamycin analogues. Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
- Known intolerance or hypersensitivity to 5FU or STZ or its excipients (notice that this criterion includes patients with known deficit of dihydropyrimidine dehydrogenase deficiency -DPD).
- Pregnant, lactating women or fertile adults not using effective birth control methods.
- For administrative matters (insurance) patients ≥ 95 are not allowed during the trial.
- Only those patients coming from the hospital pool will be included in SEQTOR trial (e.g. persons detained in an institution as a result of an official or court order are excluded).
Trial locations and contacts
37 sites in 8 countries.
37 sites in 8 countries
Germany10 sites
Bad Berka ChA Klinik für Innere Medizin
Bad Berka, 99437
Berlin Charité Universitätsmedizin
Berlin
Köln Universitätsklinikum Köln (AöR)
Cologne, 50937
UKM Facharzt für Innere Medizin Gastroenterologie, Onkologische Gastroenterologie (DGVS)
Halle
Medizinische Klinik und Poliklinik , Universitätsklinikum Hamburg-Eppendorf
Hamburg, 20246
Magdeburg Universitätsklinikum Magdeburg A. ö. R
Magdeburg, 39120
Mainz Universitätsmedizin
Mainz
Marburg Universitätsklinikum Giessen und Marburg GmbH
Marburg, 35033
Interdisciplinary Center of Neuroendocrine Tumors of the GastroEnteroPancreatic System (GEPNET-KUM) at the University of Munich
München, 81377
Medizin II am Klinik und Poliklinik rechts der Isar
München, 81675
France8 sites
UTTIOM Unité Transversale de Thérapeutiques Innovantes en Oncologie Médicale CHU Angers
Angers
University Hospital of Bordeaux Hôpital Saint-André
Bordeaux, 33075
Brest Hopital Augustin Morvan, Institut de Cancero-Hemato
Brest, Brest Cedex, 29609
Clichy Neuroendocrine Tumor (NET) Center Hôpital Beaujon
Clichy, Clichy Cedex, 92118
Hôpital Edouard Herriot
Lyon
Hôpital La Timone
Marseille
Hôpitaux Universitaires de Strasbourg Hôpital de Hautepierre
Strasbourg, Strasbourg Cedex, 67098
Institut Gustave-Roussy
Villejuif, Paris
Spain8 sites
Hospital Universitario Germans Trias i Pujol
Badalona, Barcelona
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025
Hospital Universitario Vall d'Hebron
Barcelona, 08035
Instituto Catalán de Oncología de Hospitalet
L'Hospitalet de Llobregat, Barcelona, 08908
Hospital Universitario 12 de Octubre
Madrid
HCU Virgen de la Victoria
Málaga, 29010
Hospital Central de Asturias
Oviedo, Principality of Asturias, 33006
Hospital Universitario Virgen del Rocío
Seville, 41013
Denmark3 sites
Aarhus Aarhus University Hospital NET Centre (AUH-NET)
Aarhus, 8000
Rigshospitalet NET CoE, University of Copenhagen
Copenhagen, 2100
Odense University Hospital
Odense, 5000
Netherlands3 sites
Amsterdam Academic Medical Center
Amsterdam, 1105AZ
UMCG / University of Groningen
Groningen
Maastricht UMC
Maastricht
Italy2 sites
Istituto Europeo di Oncologia- IRCCS
Milan
Istituto Nazionale Tumori (Fondazione G Pascale)
Naples, Naples, 80131
United Kingdom2 sites
Beatson West of Scotland Cancer Centre
Glasgow, Scotland
The Royal Marsden
Sutton, Surrey, SM2 5PT
About this study
Official title: Randomized Open Label Study to Compare the Efficacy and Safety of Everolimus Followed by Chemotherapy With Streptozotocin- Fluorouracilo (STZ-5FU) Upon Progression or the Reverse Sequence, in Advanced Progressive Pancreatic NETs (pNETs)
The purpose of this study is to compare streptozotocin (STZ) vs everolimus as first line treatment for advanced pNET and to elucidate which sequence of STZ based chemotherapy and the mammalian Target of Rapamycin (mTOR) inhibitor, everolimus, gives better results in terms of second Progression Free Survival (PFS) in well differentiated and advanced pancreatic NETs.
Read the detailed description
STZ plus 5-Fuorouracil (5FU) is the actual standard of care for advanced pancreatic Neuroendocrine tumours (pNETS) in the European Union. Everolimus has been recently approved for its use in advanced pNETs by the Food and Drug Administration (FDA) and in Europe by the European Medical Agency (EMA).
A randomized study is needed to have a clear knowledge about the best sequence for its administration; this is, before or after palliative chemotherapy.
There may or may not be any benefits from giving first each other treatment of the study. The information obtained from this study will help the physician improve the treatment and management of patients with advanced pNET.
This study was planned to compare STZ-5FU chemotherapy followed by everolimus upon progression versus the reverse sequence. However sequential studies with pNETs are hard to be managed in terms of time and costs. Therefore the protocol was amended to have PFS1 (progression free survival after course 1) as primary endpoint and PFS2 (i.e. progression free survival after both STZ based chemotherapy and Everolimus or the reverse order) as secondary endpoint. This information will be extremely valuable for the day to day clinical practice of pNETs oncologists
- Conditions
- Neuroendocrine Tumors
- Being tested
- Drug: Everolimus, STZ-5FU
- Keywords
- advanced pNET, everolimus, STZ-5FU, treatment sequence
- Medical subject headings
- Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug: EverolimusDrug
Also called Afinitor
10mg/daily, oral. Number of Cycles: until progression or unacceptable toxicity develops.
STZ-5FUDrug
Also called STZ based Chemotherapy
0,5g/m2 STZ on days 1-5 and 400mg/m2 5-FU on days 1-5 every 6 weeks (Moertel) or 0,5g/m2 STZ on days 1-5 and 400mg/m2 5-FU on days 1-3, and then 1 day with 1g/m2 and 1 day 400mg/m2 5-FU every 3 weeks (Uppsala).
Number of Cycles: until progression or unacceptable toxicity develops.
| Study group | Role | What they receive |
|---|---|---|
| Sequence A, drug: everolimus first | Active comparator | Everolimus (10mg/daily, oral) followed by STZ-5FU (injection/infusion; Moertel or Uppsala regime). Receives: Drug: Drug: Everolimus; Drug: STZ-5FU |
| Sequence B, drug: STZ - 5FU first | Experimental | STZ-5FU (injection/infusion; Moertel or Uppsala regime) followed by Everolimus (10 mg/ daily, oral) Receives: Drug: Drug: Everolimus; Drug: STZ-5FU |
What is being measured
The primary outcome is the main question the study is designed to answer.
First Progression Free Survival (PFS1)
Proportion of patients who are alive without progression to Course 1 from the date of randomization in STZ based CT vs Everolimus arms
Definitions for PFS rate for course 1 at 12 months:
- No: number (proportion) of patients who were not alive and progression free according to the respective definition (main, conservative, and optimistic);
- Yes: number (proportion) of patients who were alive and progression free according to the respective definition (main, conservative, and optimistic).
Measured: At 12 months
Secondary outcomes (11)
Second Progression Free Survival (Second PFS)
PFS of Course 1 (PFS1) + interval between treatments + PFS of Course 2 (PFS2), where PFS1 represents progression free survival of Course 1 and PFS2 represents progression free survival of Course 2
Measured: Until the end of study every 12 weeks, approximately up to 5 years
Progression-free Survival (PFS) to First Treatment
Time from the date of randomization to the date of first disease progression.
Measured: Throughout the study period every 12 weeks, approximately up to 5 years
Adverse Events (AEs) Rate
Number of patients expiriencing adverse events, treatment-related AEs and serious adverse events (SAEs)
Measured: Throughout the study period in continous monitoring at every visit for approximately up to 5 years
Frequency of Dose Modifications to First Treatment
Percentage of patients who require a dose reduction or interruption for management of adverse events during the study period
Measured: Throughout the study period, approximately up to 5 years
Best Overall Response (BOR) to First Study Treatment
Best response achieved with the first study treatment according to RECIST V1.0
Measured: Throughout the study period, every 12 weeks up to approximately 5 years
Objective Response Rate (ORR) to First Study Treatment
The ORR is defined as the number of patients having as their BOR to first treatment either Complete response (CR) or Partial Response (PR) measured by RECIST criteria version 1.0.
Measured: Throughout the study period every 12 weeks, up to approximately 5 years
Frequency of Dose Modifications to Second Treatment
Percentage of patients who require a dose reduction or interruption for management of adverse events during the study period
Measured: Throughout the study period, approximately up to 5 years
Overall Survival (OS)
The median OS defined as the time from the date of randomization until death from any cause. This is estimated by kaplan meier method.
Measured: Throughout the study period, up to approximately 5 years
Best Overall Response (BOR) to Second Study Treatment
Best response achieved with the second study treatment according to RECIST V1.0
Measured: Throughout the study period, every 12 weeks up to approximately 5 years
Objective Response Rate (ORR) to Second Study Treatment
The ORR is defined as the number of patients having as their BOR to second treatment either Complete response (CR) or Partial Response (PR) measured by RECIST criteria version 1.0.
Measured: Throughout the study period every 12 weeks, up to approximately 5 years
Progression-free Survival (PFS) to Second Treatment
Time from the date of first dose of second treatment to the date of second disease progression.
Measured: Throughout the study period every 12 weeks, approximately up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2014 (estimated)
- Study start27 Oct 2014
- Primary completion18 Nov 2020
- Study completion12 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Neuroendocrine TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grupo Espanol de Tumores Neuroendocrinos
- Sponsor type
- University, hospital or other
- Collaborators
- European Neuroendocrine Tumor Society, Kantar Health, Novartis Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Salazar Ramon, MD, PhD, Principal investigator, Instituto Catalán de Oncologia, ICO-Hospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02246127
- Sponsor's protocol ID
- GETNE1206
- Other IDs
- 2013-000726-66
- Acronym
- SEQTOR
- Status last verified
- May 2025
- First submitted
- 20 Aug 2014
- Last updated
- 11 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: As per GETNE guidelines and local laws
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Open Label Study to Compare the Efficacy and Safety of Everolimus Followed by Chemotherapy With Streptozotocin- Fluorouracilo (STZ-5FU) Upon Progression or the Reverse Sequence, in Advanced Progressive Pancreatic NETs (pNETs)
- ClinicalTrials.gov ID
- NCT02246127
- Acronym / sponsor ID
- SEQTOR / GETNE1206
- Conditions
- Neuroendocrine Tumors
- Keywords
- advanced pNET, everolimus, STZ-5FU, treatment sequence
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Grupo Espanol de Tumores NeuroendocrinosUniversity, hospital or other
- Collaborators
- European Neuroendocrine Tumor Society, Kantar Health, Novartis Pharmaceuticals
- Study start
- 27 Oct 2014 (actual)
- Primary completion
- 18 Nov 2020 (actual)
- Study completion
- 12 Jul 2021 (actual)
- First posted
- 22 Sep 2014 (estimated)
- Results
- Posted 11 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare streptozotocin (STZ) vs everolimus as first line treatment for advanced pNET and to elucidate which sequence of STZ based chemotherapy and the mammalian Target of Rapamycin (mTOR) inhibitor, everolimus, gives better results in terms of second Progression Free Survival (PFS) in well differentiated and advanced pancreatic NETs.
Detailed description
STZ plus 5-Fuorouracil (5FU) is the actual standard of care for advanced pancreatic Neuroendocrine tumours (pNETS) in the European Union. Everolimus has been recently approved for its use in advanced pNETs by the Food and Drug Administration (FDA) and in Europe by the European Medical Agency (EMA).
A randomized study is needed to have a clear knowledge about the best sequence for its administration; this is, before or after palliative chemotherapy.
There may or may not be any benefits from giving first each other treatment of the study. The information obtained from this study will help the physician improve the treatment and management of patients with advanced pNET.
This study was planned to compare STZ-5FU chemotherapy followed by everolimus upon progression versus the reverse sequence. However sequential studies with pNETs are hard to be managed in terms of time and costs. Therefore the protocol was amended to have PFS1 (progression free survival after course 1) as primary endpoint and PFS2 (i.e. progression free survival after both STZ based chemotherapy and Everolimus or the reverse order) as secondary endpoint. This information will be extremely valuable for the day to day clinical practice of pNETs oncologists
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence A, drug: everolimus first | Active comparator | Drug: Drug: Everolimus, Drug: STZ-5FUEverolimus (10mg/daily, oral) followed by STZ-5FU (injection/infusion; Moertel or Uppsala regime). |
| Sequence B, drug: STZ - 5FU first | Experimental | Drug: Drug: Everolimus, Drug: STZ-5FUSTZ-5FU (injection/infusion; Moertel or Uppsala regime) followed by Everolimus (10 mg/ daily, oral) |
Who may qualify
- Ages
- 18 to 94 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically proven diagnosis of unresectable or metastatic, advanced pancreatic NET.
- Documented confirmation of pancreatic NET G1 or G2 as per European Neuroendocrine Society (ENETS) classification system.
- Patients from whom a paraffin-embedded primary tumour or metastasis block is available and to be sent by Courier.
- Before study inclusion, patients must show progressive disease documented by radiology 12 months prior to study inclusion. Treatment naive patients can be also included if the patient needs active treatment with either chemotherapy or everolimus.
- Presence of measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.0, documented by a Triphasic Computed Tomography (CT) scan or multiphase MRI radiological assessment.
Key exclusion criteria (14 listed)
- Previous treatment with chemotherapy and/or mTOR inhibitors or tyrosine kinase inhibitors.
- Immune therapy or radiation therapy within 4 weeks prior to the patient entering the study.
- Hepatic artery embolization within the last 6 months (1 month if there are other sites of measurable disease), or cryoablation/radiofrequency ablation of hepatic metastasis within 2 months of enrolment.
- Previous treatment with Peptide-Receptor Radionuclide Therapy (PRRT) within the last 6 months and/or without progression following PRRT.
- Uncontrolled diabetes mellitus.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Drug: EverolimusAlso: Afinitor10mg/daily, oral. Number of Cycles: until progression or unacceptable toxicity develops. | Drug | Sequence A, drug: everolimus first, Sequence B, drug: STZ - 5FU first |
| STZ-5FUAlso: STZ based Chemotherapy0,5g/m2 STZ on days 1-5 and 400mg/m2 5-FU on days 1-5 every 6 weeks (Moertel) or 0,5g/m2 STZ on days 1-5 and 400mg/m2 5-FU on days 1-3, and then 1 day with 1g/m2 and 1 day 400mg/m2 5-FU every 3 weeks (Uppsala). Number of Cycles: until progression or unacceptable toxicity develops. | Drug | Sequence A, drug: everolimus first, Sequence B, drug: STZ - 5FU first |
Primary outcome
First Progression Free Survival (PFS1)
Time frame: At 12 months
Proportion of patients who are alive without progression to Course 1 from the date of randomization in STZ based CT vs Everolimus arms Definitions for PFS rate for course 1 at 12 months: * No: number (proportion) of patients who were not alive and progression free according to the respective definition (main, conservative, and optimistic); * Yes: number (proportion) of patients who were alive and progression free according to the respective definition (main, conservative, and optimistic).
11 secondary outcomes
Second Progression Free Survival (Second PFS)
Time frame: Until the end of study every 12 weeks, approximately up to 5 years
Progression-free Survival (PFS) to First Treatment
Time frame: Throughout the study period every 12 weeks, approximately up to 5 years
Adverse Events (AEs) Rate
Time frame: Throughout the study period in continous monitoring at every visit for approximately up to 5 years
Frequency of Dose Modifications to First Treatment
Time frame: Throughout the study period, approximately up to 5 years
Best Overall Response (BOR) to First Study Treatment
Time frame: Throughout the study period, every 12 weeks up to approximately 5 years
Objective Response Rate (ORR) to First Study Treatment
Time frame: Throughout the study period every 12 weeks, up to approximately 5 years
Frequency of Dose Modifications to Second Treatment
Time frame: Throughout the study period, approximately up to 5 years
Overall Survival (OS)
Time frame: Throughout the study period, up to approximately 5 years
Best Overall Response (BOR) to Second Study Treatment
Time frame: Throughout the study period, every 12 weeks up to approximately 5 years
Objective Response Rate (ORR) to Second Study Treatment
Time frame: Throughout the study period every 12 weeks, up to approximately 5 years
Progression-free Survival (PFS) to Second Treatment
Time frame: Throughout the study period every 12 weeks, approximately up to 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. As per GETNE guidelines and local laws
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Salazar Ramon, MD, PhD principal investigator
Instituto Catalán de Oncologia, ICO-Hospitalet
37 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Drug: Everolimus and STZ-5FU in people with Neuroendocrine Tumors, run by Grupo Espanol de Tumores Neuroendocrinos at 37 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in Germany, France, Spain, Denmark, Netherlands and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First Progression Free Survival (PFS1) (time frame: At 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2025.