Carcinoid TumorPhase 3RADIANT-2NCT00412061
Everolimus and Octreotide in Patients With Advanced Carcinoid Tumor
A Phase 3 study testing Octreotide and Everolimus in people with Carcinoid Tumor and Malignant Carcinoid Syndrome, run by Novartis Pharmaceuticals at 70 sites in 15 countries.
Trial summary
The purpose of this study was to evaluate whether everolimus 10 mg / day added to treatment with depot octreotide prolongs progression free survival compared to treatment with octreotide alone in patients with advanced carcinoid tumor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoid Tumor, Malignant Carcinoid Syndrome
- What is being tested?
- Octreotide and Everolimus
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 429 participants
- Where
- 70 sitesin 15 countries
- Study dates
- Dec 2006to Jun 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Advanced (unresectable or metastatic) carcinoid tumor
- Confirmed low-grade or intermediate-grade neuroendocrine carcinoma
- Documented progression of disease within 12 months prior to randomization.
- Measurable disease determined by triphasic computer tomography (CT) scan or magnetic resonance imaging (MRI).
Who cannot join
- Poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma, adenocarcinoid, goblet cell carcinoma, or small cell carcinoma.
- Hepatic artery embolization within the last 6 months or cryoablation of hepatic metastasis within 2 months of enrollment.
- Previous treatment with mammalian target of rapamycin (mTOR) inhibitors (sirolimus, temsirolimus, everolimus)
- Intolerance or hypersensitivity to octreotide, everolimus, or other rapamycins.
- Severe or uncontrolled medical conditions
- Chronic treatment with corticosteroids or other immunosuppressive agent.
- Other primary cancer within 3 years.
- Other protocol-defined inclusion/exclusion criteria applied
Trial locations and contacts
70 sites in 15 countries.
70 sites in 15 countries
United States38 sites
New York Oncology Hematology, P.C. Dept. of New York Oncology. PC
Albany, New York, 12206
Pacific Cancer Medical Center, Inc.
Anaheim, California, 92801
University of Colorado Dept. of Univ. of Colorado
Aurora, Colorado, 80045
Texas Oncology, P.A. Central Austin Cancer Center
Austin, Texas, 78731
South Texas Institute of Cancer S. Tex Inst.- Corpus Christi
Corpus Christi, Texas, 78405
Sammons Cancer Center - Texas Oncology Sammons Cancer Center (SC)
Dallas, Texas, 75246
Rocky Mountain Cancer Centers Dept of Rocky Mountain (2)
Denver, Colorado, 80218
Duke University Medical Center Dept. of Duke Cancer Center
Durham, North Carolina, 27710
Highlands Oncology Group The Center for Chest Care
Fayetteville, Arkansas, 72703
Texas Oncology, P.A. Forth Worth -- 12th Avenue
Fort Worth, Texas, 76104
Cancer Centers of the Carolinas CC of C -Eastside
Greenville, South Carolina, 29615
University of Texas/MD Anderson Cancer Center Gastrointestinal Med. Oncology
Houston, Texas, 77030
Indiana University Dept.of IndianaUniv.CancerCtr
Indianapolis, Indiana, 46202
Central Indiana Cancer Centers CICC - South
Indianapolis, Indiana, 46227
University of Iowa Medical Center Internal Medicine
Iowa City, Iowa, 52242
University of Kansas Cancer Center Deptof Uof Kansas CancerCenter
Kansas City, Kansas, 66160
Dartmouth Hitchcock Medical Center Medical Oncology
Lebanon, New Hampshire, 03756
Hematology Oncology Services of Arkansas
Little Rock, Arkansas, 72205
Cedars Sinai Medical Center SC-2
Los Angeles, California, 90048
University of California at Los Angeles UCLA New SC Address
Los Angeles, California, 90095
Norton Cancer Institute Clinical Research Program
Louisville, Kentucky, 40202
University of Wisconsin / Paul P. Carbone Comp Cancer Center GI Oncology Research Center
Madison, Wisconsin, 53792
LSU HEALTH SCIENCES CENTER/ LSU SCHOOL OF MEDICINE Deptof LSU Health Sciences (2)
New Orleans, Louisiana, 70112
New York University Medical Center NYU Medical Center (2)
New York, New York, 10016
Cancer Care and Hematology Specialists of Chicagoland Niles
Niles, Illinois, 60714
Virginia Oncology Associates VOA - Lake Wright
Norfolk, Virginia, 23502
Eastern Connecticut Hematology & Oncology Associates Dept. of ECHO
Norwich, Connecticut, 06360
Ocala Oncology Center Dept. of Ocala Oncology Center
Ocala, Florida, 34471
Kansas City Cancer Center KCCC Business Office
Overland Park, Kansas, 66210
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111-2497
Mayo Clinic - Rochester Division of Hematology
Rochester, Minnesota, 55905
Cancer Centers of Connecticut Southington Location
Southington, Connecticut, 06489
Washington University School Of Medicine-Siteman Cancer Ctr Division of Oncology
St Louis, Missouri, 63110
The Center for Cancer Care and Research
St Louis, Missouri, 63141
Hematology Oncology PC Dept.of Hematology Oncology(2)
Stamford, Connecticut, 06902
University of Arizona / Arizona Cancer Center Deptof Uof A/Arizona Cancer(2)
Tucson, Arizona, 85719
Tyler Cancer Center
Tyler, Texas, 75702
Northwest Cancer Specialists Compass Oncology -BKM
Vancouver, Washington, 98684
France7 sites
Novartis Investigative Site
Clichy Cédex, 92118
Novartis Investigative Site
Lille, 59020
Novartis Investigative Site
Montpellier, 34298
Novartis Investigative Site
Paris, 75908
Novartis Investigative Site
Strasbourg, France, 67098
Novartis Investigative Site
Toulouse, 31059
Novartis Investigative Site
Villejuif, 94805
Italy5 sites
Novartis Investigative Site
Bologna, BO, 40138
Novartis Investigative Site
Milan, MI, 20100
Novartis Investigative Site
Milan, MI, 20141
Novartis Investigative Site
Perugia, PG, 06132
Novartis Investigative Site
Pisa, PI, 56126
Canada4 sites
Novartis Investigative Site
London, Ontario, N6A 4L6
Novartis Investigative Site
Montreal, Quebec, H1T 2M4
Novartis Investigative Site
Montreal, Quebec, H2X 1P1
Novartis Investigative Site
Toronto, Ontario, M5G 2M9
Australia3 sites
Novartis Investigative Site
Herston, Queensland, 4029
Novartis Investigative Site
Kogarah, New South Wales, 2217
Novartis Investigative Site
South Brisbane, Queensland, 4101
Czechia2 sites
Novartis Investigative Site
Prague, Czech Republic, 128 08
Novartis Investigative Site
Příbram, 261 95
Germany2 sites
Novartis Investigative Site
Berlin, 13353
Novartis Investigative Site
Hamburg, 20246
Netherlands2 sites
Novartis Investigative Site
Groningen, 9713 GZ
Novartis Investigative Site
Rotterdam, 3015 CE
Slovakia1 site
Novartis Investigative Site
Bratislava, Slovak Republic, 813 69
About this study
Official title: A Randomized, Double-blind Placebo-controlled, Multicenter Phase III Study in Patients With Advanced Carcinoid Tumor Receiving Octreotide Depot and Everolimus 10 mg/Day or Octreotide Depot and Placebo
The purpose of this study was to evaluate whether everolimus 10 mg / day added to treatment with depot octreotide prolongs progression free survival compared to treatment with octreotide alone in patients with advanced carcinoid tumor.
- Conditions
- Carcinoid Tumor, Malignant Carcinoid Syndrome
- Being tested
- Octreotide, Placebo, Everolimus
- Keywords
- Cancer, Carcinoid, Tumor, Neuroendocrine, Carcinoma, Everolimus, Octreotide
- Medical subject headings
- Carcinoid Tumor, Malignant Carcinoid Syndrome, Neoplasms, Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OctreotideDrug
Also called Sandostatin LAR® Depot
Octreotide 30 mg intramuscularly (i.m.) every 28 days.
PlaceboDrug
A 10-mg oral daily dosing regimen (two 5-mg tablets) of matching placebo.
EverolimusDrug
Also called RAD001
A 10-mg oral daily dosing regimen (two 5-mg tablets) of everolimus.
| Study group | Role | What they receive |
|---|---|---|
| Octreotide+ Everolimus | Experimental | Everolimus was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity. Each treatment cycle lasted 28 days. Patients received their first dose of everolimus at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1, Day 1. Receives: Drug: Octreotide; Drug: Everolimus |
| Octreotide+ Placebo | Placebo comparator | Matching placebo was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity; Each treatment cycle lasted 28 days. Patients received their first dose of matching placebo at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1 Day 1. Receives: Drug: Octreotide; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS) as Per Adjudicated Central Radiology Review
Progression free survival (PFS) is defined as the time from randomization to the date of first documented disease progression or death from any cause. The primary analysis of PFS was based on the independent central adjudicated assessment using Kaplan-Meier method.
Measured: Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 10 January 2007, until cut-off date 02 April 2010
Secondary outcomes (6)
Best Overall Response Rate as Per Adjudicated Central Radiology Review Based on Response Evaluation Criteria in Solid Tumors (RECIST)
The best overall response rate is defined as the percentage of patients having achieved confirmed Complete Response + Partial Response. Complete Response (CR) = at least two determinations of CR at least 4 weeks apart before progression. • Partial response (PR) = at least two determinations of PR or better at least 4 weeks apart before progression.
Measured: Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 10 January 2007, until cut-off date 02 April 2010
Progression Free Survival (PFS) as Per Adjudicated Central Review by Baseline 5-hydroxyindoleacetic Acid (5-HIAA) Level
5-HIAA levels in urine are frequently elevated in patients with advanced carcinoid tumors. Baseline levels of 5-HIAA in urine were defined as 'High' if they exceeded the median value, and 'Low' if they were lower than or equal to the median.
Measured: If elevated at baseline, evaluated every cycle visit (28 days/cycle) reported between day of first patient randomised, 10 January 2007, until cut-off date 02 April 2010
Overall Survival Using Kaplan-Meier Methodology
Overall survival was defined as the time from the date of randomization to the date of death from any cause. If a patient was not known to have died, survival was censored at the date of last contact. Kaplan-Meier methodology was used to estimate the median overall survival for each treatment group.
Measured: Months 12, 24, 36, 48
Number of Patients With Adverse Events (AEs), Clinically Notable AE, Death, Serious Adverse Events (SAEs) (Double-Blind Phase)
AEs are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. SAEs are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.
Measured: From first day of treatment up to 28 days after last day of treatment in double blind
Number of Patients With Adverse Events (AEs), Clinically Notable AE, Death, Serious Adverse Events (SAEs) (Open Label Phase)
AEs are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. SAEs are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.
Measured: From first day of treatment up to 28 days after last day of treatment in double blind
Progression Free Survival (PFS) as Per Adjudicated Central Review by Baseline Chromogranin A (CgA)
Serum CgA levels in urine are frequently elevated in patients with advanced carcinoid tumors. Baseline levels of serum CgA were characterized relative to the upper limited of normal (ULN). CgA levels exceeding 2 x ULN were considered to be 'Elevated'; otherwise considered as "Non-elevated".
Measured: If elevated at baseline, evaluated every cycle visit (28 days/cycle) reported between day of first patient randomised, 10 January 2007, until cut-off date 02 April 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2006 (estimated)
- Study startDec 2006
- Primary completionApr 2010
- Study completionJun 2013
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.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Carcinoid TumorStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 429 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00412061
- Sponsor's protocol ID
- CRAD001C2325
- Other IDs
- 2006-004507-18
- Acronym
- RADIANT-2
- Status last verified
- Nov 2014
- First submitted
- 13 Dec 2006
- Last updated
- 21 Nov 2014
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Pavel ME, Baudin E, Oberg KE, Hainsworth JD, Voi M, Rouyrre N, Peeters M, Gross DJ, Yao JC. Efficacy of everolimus plus octreotide LAR in patients with advanced neuroendocrine tumor and carcinoid syndrome: final overall survival from the randomized, placebo-controlled phase 3 RADIANT-2 study. Ann Oncol. 2017 Jul 1;28(7):1569-1575. doi: 10.1093/annonc/mdx193.
PubMed 28444114Fazio N, Granberg D, Grossman A, Saletan S, Klimovsky J, Panneerselvam A, Wolin EM. Everolimus plus octreotide long-acting repeatable in patients with advanced lung neuroendocrine tumors: analysis of the phase 3, randomized, placebo-controlled RADIANT-2 study. Chest. 2013 Apr;143(4):955-962. doi: 10.1378/chest.12-1108.
PubMed 23187897Pavel ME, Hainsworth JD, Baudin E, Peeters M, Horsch D, Winkler RE, Klimovsky J, Lebwohl D, Jehl V, Wolin EM, Oberg K, Van Cutsem E, Yao JC; RADIANT-2 Study Group. Everolimus plus octreotide long-acting repeatable for the treatment of advanced neuroendocrine tumours associated with carcinoid syndrome (RADIANT-2): a randomised, placebo-controlled, phase 3 study. Lancet. 2011 Dec 10;378(9808):2005-2012. doi: 10.1016/S0140-6736(11)61742-X. Epub 2011 Nov 25.
PubMed 22119496
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind Placebo-controlled, Multicenter Phase III Study in Patients With Advanced Carcinoid Tumor Receiving Octreotide Depot and Everolimus 10 mg/Day or Octreotide Depot and Placebo
- ClinicalTrials.gov ID
- NCT00412061
- Acronym / sponsor ID
- RADIANT-2 / CRAD001C2325
- Conditions
- Carcinoid Tumor, Malignant Carcinoid Syndrome
- Keywords
- Cancer, Carcinoid, Tumor, Neuroendocrine, Carcinoma, Everolimus, Octreotide
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 429 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Apr 2010 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 15 Dec 2006 (estimated)
- Results
- Posted 12 Mar 2012
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 was to evaluate whether everolimus 10 mg / day added to treatment with depot octreotide prolongs progression free survival compared to treatment with octreotide alone in patients with advanced carcinoid tumor.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Octreotide+ Everolimus | Experimental | Drug: Octreotide, Drug: EverolimusEverolimus was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity. Each treatment cycle lasted 28 days. Patients received their first dose of everolimus at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1, Day 1. |
| Octreotide+ Placebo | Placebo comparator | Drug: Octreotide, Drug: PlaceboMatching placebo was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity; Each treatment cycle lasted 28 days. Patients received their first dose of matching placebo at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1 Day 1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Advanced (unresectable or metastatic) carcinoid tumor
- Confirmed low-grade or intermediate-grade neuroendocrine carcinoma
- Documented progression of disease within 12 months prior to randomization.
- Measurable disease determined by triphasic computer tomography (CT) scan or magnetic resonance imaging (MRI).
Key exclusion criteria (8 listed)
- Poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma, adenocarcinoid, goblet cell carcinoma, or small cell carcinoma.
- Hepatic artery embolization within the last 6 months or cryoablation of hepatic metastasis within 2 months of enrollment.
- Previous treatment with mammalian target of rapamycin (mTOR) inhibitors (sirolimus, temsirolimus, everolimus)
- Intolerance or hypersensitivity to octreotide, everolimus, or other rapamycins.
- Severe or uncontrolled medical conditions
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 |
|---|---|---|
| OctreotideAlso: Sandostatin LAR® DepotOctreotide 30 mg intramuscularly (i.m.) every 28 days. | Drug | Octreotide+ Everolimus, Octreotide+ Placebo |
| PlaceboA 10-mg oral daily dosing regimen (two 5-mg tablets) of matching placebo. | Drug | Octreotide+ Placebo |
| EverolimusAlso: RAD001A 10-mg oral daily dosing regimen (two 5-mg tablets) of everolimus. | Drug | Octreotide+ Everolimus |
Primary outcome
Progression Free Survival (PFS) as Per Adjudicated Central Radiology Review
Time frame: Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 10 January 2007, until cut-off date 02 April 2010
Progression free survival (PFS) is defined as the time from randomization to the date of first documented disease progression or death from any cause. The primary analysis of PFS was based on the independent central adjudicated assessment using Kaplan-Meier method.
6 secondary outcomes
Best Overall Response Rate as Per Adjudicated Central Radiology Review Based on Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 10 January 2007, until cut-off date 02 April 2010
Progression Free Survival (PFS) as Per Adjudicated Central Review by Baseline 5-hydroxyindoleacetic Acid (5-HIAA) Level
Time frame: If elevated at baseline, evaluated every cycle visit (28 days/cycle) reported between day of first patient randomised, 10 January 2007, until cut-off date 02 April 2010
Overall Survival Using Kaplan-Meier Methodology
Time frame: Months 12, 24, 36, 48
Number of Patients With Adverse Events (AEs), Clinically Notable AE, Death, Serious Adverse Events (SAEs) (Double-Blind Phase)
Time frame: From first day of treatment up to 28 days after last day of treatment in double blind
Number of Patients With Adverse Events (AEs), Clinically Notable AE, Death, Serious Adverse Events (SAEs) (Open Label Phase)
Time frame: From first day of treatment up to 28 days after last day of treatment in double blind
Progression Free Survival (PFS) as Per Adjudicated Central Review by Baseline Chromogranin A (CgA)
Time frame: If elevated at baseline, evaluated every cycle visit (28 days/cycle) reported between day of first patient randomised, 10 January 2007, until cut-off date 02 April 2010
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28444114Pavel ME, Baudin E, Oberg KE, Hainsworth JD, Voi M, Rouyrre N, Peeters M, Gross DJ, Yao JC. Efficacy of everolimus plus octreotide LAR in patients with advanced neuroendocrine tumor and carcinoid syndrome: final overall survival from the randomized, placebo-controlled phase 3 RADIANT-2 study. Ann Oncol. 2017 Jul 1;28(7):1569-1575. doi: 10.1093/annonc/mdx193.
- Derived from this study: PubMed 23187897Fazio N, Granberg D, Grossman A, Saletan S, Klimovsky J, Panneerselvam A, Wolin EM. Everolimus plus octreotide long-acting repeatable in patients with advanced lung neuroendocrine tumors: analysis of the phase 3, randomized, placebo-controlled RADIANT-2 study. Chest. 2013 Apr;143(4):955-962. doi: 10.1378/chest.12-1108.
- Derived from this study: PubMed 22119496Pavel ME, Hainsworth JD, Baudin E, Peeters M, Horsch D, Winkler RE, Klimovsky J, Lebwohl D, Jehl V, Wolin EM, Oberg K, Van Cutsem E, Yao JC; RADIANT-2 Study Group. Everolimus plus octreotide long-acting repeatable for the treatment of advanced neuroendocrine tumours associated with carcinoid syndrome (RADIANT-2): a randomised, placebo-controlled, phase 3 study. Lancet. 2011 Dec 10;378(9808):2005-2012. doi: 10.1016/S0140-6736(11)61742-X. Epub 2011 Nov 25.
- Visit NovartisClinicalTrials.com: Pre-qualify for a trial, and view a list of trials and participating study centers.Link provided by the sponsor.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
70 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Octreotide and Everolimus in people with Carcinoid Tumor and Malignant Carcinoid Syndrome, run by Novartis Pharmaceuticals at 70 sites in 15 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 4 inclusion and 8 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 21 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 70 sites in United States, France, Italy, Canada, Australia and 10 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. Some participants in this study may receive a placebo. 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 12 Mar 2012). 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?
Progression Free Survival (PFS) as Per Adjudicated Central Radiology Review (time frame: Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 10 January 2007, until cut-off date 02 April 2010). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00412061, which also lists 3 linked publications.
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 21 Nov 2014.