Carcinoma, Squamous Cell of the Head and NeckPhase 3NCT01166542
Efficacy Study of REOLYSIN® in Combination With Paclitaxel and Carboplatin in Platinum-Refractory Head and Neck Cancers
A Phase 3 study testing REOLYSIN, Carboplatin and Paclitaxel in people with Carcinoma, Squamous Cell of the Head and Neck, run by Oncolytics Biotech at 77 sites in 13 countries.
Trial summary
The purpose of this Phase 3 study is to evaluate overall survival and progression free survival following intravenous administration of REOLYSIN (Reovirus Serotype 3 Dearing) in combination with paclitaxel and carboplatin versus chemotherapy treatment alone, in patients with metastatic or recurrent Squamous Cell… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Squamous Cell of the Head and Neck
- What is being tested?
- REOLYSIN, Carboplatin and Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 167 participants
- Where
- 77 sitesin 13 countries
- Study dates
- Jun 2010to May 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- have recurrent or metastatic (R/M) histologically confirmed squamous cell carcinoma (SCC) of the head and neck (oropharynx, oral cavity, larynx, hypopharynx) or squamous cell nasopharynx cancer (NPC) with distal metastasis(es) and no secondary cancers (Patients with NPC without distal metastasis(es) or with undifferentiated NPC are not eligible).
- have at least one lesion that is measurable by computed tomography or magnetic resonance imaging (Lesions persisting in previously treated radiation fields are considered not evaluable for response except if representing a relapse in a mucosal or nodal lesion that previously demonstrated a complete response. Any new lesion within the previous radiation fields is acceptable for determination of response and/or progression).
- have completed first line chemotherapy for R/M SCCHN which progressed on or within 190 days following the completion of platinum or platinum-based chemotherapy.
- have no continuing acute toxic effects (except alopecia) of any prior radiotherapy, chemotherapy, or surgical procedures. Any surgery involving the SCC for which the patient is being treated (except biopsies) must have occurred at least 28 days prior to study enrollment.
- have received no chemotherapy, radiotherapy, immunotherapy or hormonal therapy within 28 days.
- have ECOG Performance Score of ≤ 2.
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- have life expectancy of at least 3 months.
- absolute neutrophil count (ANC)≥ 1.5 x 10^9/L ; platelets ≥100 x 10^9/L]; hemoglobin ≥9.0 g/dL; serum creatinine ≤1.5 xULN; bilirubin ≤1.5 x ULN; AST/ALT ≤2.5 x ULN.
- negative pregnancy test for females with childbearing potential.
- Be wiling and able to comply with scheduled visits, the treatment plan, and laboratory tests.
Who cannot join
- receive concurrent therapy with any other investigational anticancer agent while on study.
- have been treated with a taxane for SCCHN.
- have current -- or with a history of -- brain metastases because of their poor prognosis and because of the frequent development of progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- be on chronic immunosuppressive therapy or have known HIV infection or active hepatitis B or C.
- be a pregnant or breast-feeding woman. Female patients of childbearing potential must agree to use effective contraception, be surgically sterile, or be postmenopausal. Male patients must agree to use effective contraception or be surgically sterile. Barrier methods are a recommended form of contraception.
- have clinically significant cardiac disease (New York Heart Association, Class III or IV) including, but not limited to, pre-existing arrhythmia, uncontrolled angina pectoris, or myocardial infarction within 1 year prior to study entry.
- have dementia or any altered mental status that would prohibit informed consent.
- have any other acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the Principal Investigator, would make the patient inappropriate for this study.
Trial locations and contacts
77 sites in 13 countries.
77 sites in 13 countries
United States21 sites
Emory University - Winship Cancer Institute
Altanta, Georgia, 30322
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21231
Mary Bird Perkinds Cancer Center - Baton Rouge
Baton Rouge, Louisiana, 70809
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Providence Health and Services
Burbank, California, 91505
Medical University of South Carolina
Charleston, South Carolina, 29425
Case Comprehensive Cancer Center, University Hospitals Case Medical Center
Cleveland, Ohio, 44106
Wilshire Oncology Medical Group
Corona, California, 92879
Texas Oncology- Sammons Cancer Center
Dallas, Texas, 75246
Rocky Mountain Cancer Centers
Denver, Colorado, 80218
Alexian Brothers Hospital Network
Elk Grove Village, Illinois, 60007
Columbia Basin Hematology and Oncology
Kennewick, Washington, 99336
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 59169
Pasco Hernando Oncology Associates, PA
New Port Richey, Florida, 34652
BMS Physician Practice, A Medical Corporation DBA Medical Oncology Care Associates
Orange, California, 92868
Cancer Therapy and Research Center at UTHSCSA
San Antonio, Texas, 78229
Montefiore Medical Center
The Bronx, New York, 10467
Mercy Cancer Center
Toledo, Ohio, 43623
Arizona Oncology Associates
Tucson, Arizona, 85715
Texas Oncology - Tyler
Tyler, Texas, 75702
Russia14 sites
State Health Care Institution "Arkhangelsk Regional Clinical Oncology Dispensary"
Arkhangelsk
Regional State Health Care Institution "Belgorod Oncology Dispensary"
Belgorod
State Health Care Institution "Chelyabinsk Regional Oncology Dispensary"
Chelyabinsk
State Health Care Institution "Republican Clinical Oncology Dispensary of Ministry of Health of the Republic of Tatarstan"
Kazan'
State Budgetary Health Care Institution "Clinical Oncology Dispensary #1" of Krasnodar Region Health Care Department
Krasnodar
Regional Budgetary Health Care Institution "Kursk Regional Oncology Dispensary" of Health Care Committee of Kursk region
Kursk
Federal State Budgetary Institution "Medical Research Radiology Center" of Ministry of Public Health and Social Development of Russian Federation, Obninsk
Obninsk
Federal State Budgetary Institution "N. N. Petrov Oncology Research Institute" of Ministry of Public Health and Social Development of the Russian Federation
Saint Petersburg
Federal State Budgetary Institution "Russian Research Centre of Radiology and Surgery technologies" of Ministry of Public Health and Social Development of the Russian Federation
Saint Petersburg
St.Petersburg State Health Care Institution City Clinical Oncology Dispensary"
Saint Petersburg
State Health Care Institution "Oncology Dispensary №2" of Krasnodar Region Health Care Department
Sochi
State Health Care Institution "Tula Regional Oncology Dispensary"
Tula
State Budgetary Healthcare Institution "Republic Clinical Oncology Dispensary Ministry of Health of Bashkortostan"
Ufa
State Budgetary Health Care Institution of the Yaroslavl region "Regional Clinical Oncological Hospital"
Yaroslavl
United Kingdom9 sites
Beatson West of Scotland Cancer Center
Glasgow, G12 0YN
Royal Surrey County Hospital
Guildford, GU2 7WG
St. James's University Hospital
Leeds, LS9 7TF
Guy's and St. Thomas Hospital
London, SE1 9RT
The Royal Marsden Cancer Center, Fulham Road branch
London, SW3 6JJ
Clatterbridge Centre for Oncology NHS Foundation Trust
Metropolitan Borough of Wirral, CH634JY
The Royal Marsden Cancer Center, Sutton Branch
Sutton, SM2 5PT
Musgrove Park Hospital
Taunton, TA1 5DA
The Velindre Hospital
Whitchurch, CF14 2TL
Spain7 sites
Hospital Vall D'Hebron
Barcelona, 08035
Instituto Catlan de Oncologia (ICO) - Hospital Duran i Reynals
Barcelona, 08908
Hospital Clinic i Provincial de Barcelona
Barcelona
Hospital Santa Creu I Sant Pau
Barcelona
Instituto Catlan de Oncologia (ICO) - Hospital Germans Trias I Pujol
Barcelona
Hospital de Basurto
Bilbao
Hospital de Navarra
Pamplona
Hungary5 sites
Fovarosi Onkormanyzat Uzsoki Utcai Kórház
Budapest
Orszagos Onkologiai Intezet
Budapest
Pecsi Tudomanyegyetem
Pécs
Szegedi Tudományegyetem
Szegedi
Markusovszky Korhaz
Szombathely
Canada4 sites
Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2
Juravinski Cancer Center
Hamilton, Ontario, L8V 5C2
London Health Sciences Centre
London, Ontario, N6A 4L6
Hopital Notre-Dame
Montreal, Quebec, H2L 4M1
Italy4 sites
Ufficio Sperimentazioni Cliniche c/o S.C. Oncologia Medica
Cuneo
Fondazione IRCCS Istituto Nazionale del Tumori
Milan
Ospedale San Paolo - Oncologia Medica
Milan
University Hospital in Modena
Modena
Poland4 sites
Centrum Onkologii - Instytyt im.M.Skłodowskiej-Curie
Krakow
Wojewódzki Szpital Specjalistyczny im. M.Kopernika
Lodz
Szpital MSWiA - Centrum Onkologi
Olsztyn
Wielkopolskie Centrum Onkologii
Poznan
Belgium3 sites
ZNA Middelheim
Antwerp
University Hospital Antwerp
Edegem
Universitair Ziekenhuis Brussel
Jette, 1090
France3 sites
Hopital Saint-André / Service d'Oncologie-Radiothérapie
Bordeaux, 33075
Centre Antoine Lacassagne / Oncologie Médicale
Nice, 06189
Institut Curie / Département d'Oncologie Médicale
Paris, 75248
About this study
Official title: Randomized, Double-blind, Multicenter Two-Stage Adaptive Phase 3 Study of Intravenous Administration of REOLYSIN (Reovirus Type 3 Dearing) in Combination With Paclitaxel and Carboplatin Versus the Chemotherapy Alone in Patients With Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck Who Have Progressed on or After Prior Platinum-Based Chemotherapy
The purpose of this Phase 3 study is to evaluate overall survival and progression free survival following intravenous administration of REOLYSIN (Reovirus Serotype 3 Dearing) in combination with paclitaxel and carboplatin versus chemotherapy treatment alone, in patients with metastatic or recurrent Squamous Cell Carcinoma of the Head and Neck.
Read the detailed description
Squamous cell carcinoma of the head and neck is the sixth most common cancer in the world. More than 50% of patients diagnosed with advanced regional disease will relapse locally or at distant sites. Initial therapeutic options include irradiation, surgery and chemotherapy. The most commonly used agents are cisplatin and carboplatin, generally in combination with 5-FU or a taxane. Erbitux has been approved for use in first-line with radiation and in second-line as monotherapy. Only about a third of the patients will respond to first-line platinum-based therapy and the median overall survival is about 6-9 months.
Preliminary assessment of a Phase 1-2 study conducted in the UK investigating the combination of REOLYSIN, carboplatin and paclitaxel suggested that patients with head and neck carcinomas may represent a group of patients in whom this treatment combination is active. Studies have also shown that paclitaxel and carboplatin combination therapy may be effective in head and neck cancers, even in heavily pretreated patients and those resistant to previous treatment. These results strongly support the utility of the carboplatin/paclitaxel combination as a control arm for salvage therapy in platinum refractory patients, a patient group with few and poor treatment options and with no gold standard therapy.
This Phase 3 study is designed to compare response rates following intravenous administration of REOLYSIN (Reovirus Type 3 Dearing) in combination with paclitaxel and carboplatin versus chemotherapy treatment alone, in patients with metastatic or recurrent Squamous Cell Carcinoma of the Head and Neck.
Overall survival is a primary endpoint of this trial. Patients will be clinically evaluated after each course of treatment and radiologically every 6 weeks on and after treatment. The safety of the paclitaxel and carboplatin with intravenous blinded placebo or intravenous blinded REOLYSIN will also be assessed.
- Being tested
- REOLYSIN, Carboplatin, Paclitaxel, Placebo
- Keywords
- carcinoma, squamous cell, head, neck, REOLYSIN (Reovirus Type 3 Dearing), chemotherapy, Carboplatin, Paclitaxel, metastatic, recurrent
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Carcinoma, Neoplasm Metastasis, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REOLYSINBiological
Also called reovirus serotype 3 Dearing Strain
3E10 TCID50, 1 hour intravenous infusion, administered on Days 1, 2, 3, 4 and 5 of a 21 day cycle
CarboplatinDrug
5 AUC mg/mL min, 30 min intravenous infusion, given on Day 1 of a 21 day cycle
PaclitaxelDrug
175 mg/m2, 3 hour intravenous infusion, given on Day 1 of a 21 day cycle
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| REOLYSIN, paclitaxel, carboplatin | Active comparator | Not described Receives: Biological: REOLYSIN; Drug: Carboplatin; Drug: Paclitaxel |
| placebo, paclitaxel, carboplatin | Placebo comparator | Not described Receives: Drug: Carboplatin; Drug: Paclitaxel; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: every 3 months until death.
Secondary outcomes (4)
Progression-free survival
Measured: Assessed every 6 weeks until disease progression or death.
Objective response (complete response (CR) + partial response (PR)) rate and duration
Measured: Evaluation of response is conducted every 6 weeks on and after study. Duration of objective response is measured from the time measurement criteria are first met for CR or PR until recurrent or progressive disease is objectively documented.
Number of participants with adverse events as a measure of safety and tolerability of REOLYSIN when administered in combination with paclitaxel and carboplatin.
Measured: Within 30 days of the last dose of REOLYSIN.
Compare Best % Tumor Specific Response in loco-regional disease and/or metastatic disease for the treatment regimens in the study population
Measured: Assessed every 6 weeks until disease progression or death.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2010 (estimated)
- Study startJun 2010
- Primary completionApr 2012
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Squamous Cell of the Head and NeckStudies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oncolytics Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- James A Bonner, MD, Principal investigator, University of Alabama at Birmingham, Birmingham, AB, USKevin Harrington, MBBS MRCP FRCR, Principal investigator, The Royal Marsden Hospital, London, UKJan Vermorken, MD, PhD, Principal investigator, University Hospital, Antwerp, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01166542
- Sponsor's protocol ID
- REO 018
- Status last verified
- Nov 2014
- First submitted
- 13 Jul 2010
- Last updated
- 5 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Multicenter Two-Stage Adaptive Phase 3 Study of Intravenous Administration of REOLYSIN (Reovirus Type 3 Dearing) in Combination With Paclitaxel and Carboplatin Versus the Chemotherapy Alone in Patients With Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck Who Have Progressed on or After Prior Platinum-Based Chemotherapy
- ClinicalTrials.gov ID
- NCT01166542
- Acronym / sponsor ID
- REO 018
- Keywords
- carcinoma, squamous cell, head, neck, REOLYSIN (Reovirus Type 3 Dearing), chemotherapy, Carboplatin, Paclitaxel
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- Oncolytics BiotechIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 21 Jul 2010 (estimated)
- Results
- Not posted in the source record
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 Phase 3 study is to evaluate overall survival and progression free survival following intravenous administration of REOLYSIN (Reovirus Serotype 3 Dearing) in combination with paclitaxel and carboplatin versus chemotherapy treatment alone, in patients with metastatic or recurrent Squamous Cell Carcinoma of the Head and Neck.
Detailed description
Squamous cell carcinoma of the head and neck is the sixth most common cancer in the world. More than 50% of patients diagnosed with advanced regional disease will relapse locally or at distant sites. Initial therapeutic options include irradiation, surgery and chemotherapy. The most commonly used agents are cisplatin and carboplatin, generally in combination with 5-FU or a taxane. Erbitux has been approved for use in first-line with radiation and in second-line as monotherapy. Only about a third of the patients will respond to first-line platinum-based therapy and the median overall survival is about 6-9 months.
Preliminary assessment of a Phase 1-2 study conducted in the UK investigating the combination of REOLYSIN, carboplatin and paclitaxel suggested that patients with head and neck carcinomas may represent a group of patients in whom this treatment combination is active. Studies have also shown that paclitaxel and carboplatin combination therapy may be effective in head and neck cancers, even in heavily pretreated patients and those resistant to previous treatment. These results strongly support the utility of the carboplatin/paclitaxel combination as a control arm for salvage therapy in platinum refractory patients, a patient group with few and poor treatment options and with no gold standard therapy.
This Phase 3 study is designed to compare response rates following intravenous administration of REOLYSIN (Reovirus Type 3 Dearing) in combination with paclitaxel and carboplatin versus chemotherapy treatment alone, in patients with metastatic or recurrent Squamous Cell Carcinoma of the Head and Neck.
Overall survival is a primary endpoint of this trial. Patients will be clinically evaluated after each course of treatment and radiologically every 6 weeks on and after treatment. The safety of the paclitaxel and carboplatin with intravenous blinded placebo or intravenous blinded REOLYSIN will also be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| REOLYSIN, paclitaxel, carboplatin | Active comparator | Biological: REOLYSIN, Drug: Carboplatin, Drug: Paclitaxel |
| placebo, paclitaxel, carboplatin | Placebo comparator | Drug: Carboplatin, Drug: Paclitaxel, Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- have recurrent or metastatic (R/M) histologically confirmed squamous cell carcinoma (SCC) of the head and neck (oropharynx, oral cavity, larynx, hypopharynx) or squamous cell nasopharynx cancer (NPC) with distal metastasis(es) and no secondary cancers (Patients with NPC without distal metastasis(es) or with undifferentiated NPC are not eligible).
- have at least one lesion that is measurable by computed tomography or magnetic resonance imaging (Lesions persisting in previously treated radiation fields are considered not evaluable for response except if representing a relapse in a mucosal or nodal lesion that previously demonstrated a complete response. Any new lesion within the previous radiation fields is acceptable for determination of response and/or progression).
- have completed first line chemotherapy for R/M SCCHN which progressed on or within 190 days following the completion of platinum or platinum-based chemotherapy.
- have no continuing acute toxic effects (except alopecia) of any prior radiotherapy, chemotherapy, or surgical procedures. Any surgery involving the SCC for which the patient is being treated (except biopsies) must have occurred at least 28 days prior to study enrollment.
- have received no chemotherapy, radiotherapy, immunotherapy or hormonal therapy within 28 days.
Key exclusion criteria (8 listed)
- receive concurrent therapy with any other investigational anticancer agent while on study.
- have been treated with a taxane for SCCHN.
- have current -- or with a history of -- brain metastases because of their poor prognosis and because of the frequent development of progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- be on chronic immunosuppressive therapy or have known HIV infection or active hepatitis B or C.
- be a pregnant or breast-feeding woman. Female patients of childbearing potential must agree to use effective contraception, be surgically sterile, or be postmenopausal. Male patients must agree to use effective contraception or be surgically sterile. Barrier methods are a recommended form of contraception.
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 |
|---|---|---|
| REOLYSINAlso: reovirus serotype 3 Dearing Strain3E10 TCID50, 1 hour intravenous infusion, administered on Days 1, 2, 3, 4 and 5 of a 21 day cycle | Biological | REOLYSIN, paclitaxel, carboplatin |
| Carboplatin5 AUC mg/mL min, 30 min intravenous infusion, given on Day 1 of a 21 day cycle | Drug | REOLYSIN, paclitaxel, carboplatin, placebo, paclitaxel, carboplatin |
| Paclitaxel175 mg/m2, 3 hour intravenous infusion, given on Day 1 of a 21 day cycle | Drug | REOLYSIN, paclitaxel, carboplatin, placebo, paclitaxel, carboplatin |
| PlaceboPlacebo | Drug | placebo, paclitaxel, carboplatin |
Primary outcome
Overall survival
Time frame: every 3 months until death.
4 secondary outcomes
Progression-free survival
Time frame: Assessed every 6 weeks until disease progression or death.
Objective response (complete response (CR) + partial response (PR)) rate and duration
Time frame: Evaluation of response is conducted every 6 weeks on and after study. Duration of objective response is measured from the time measurement criteria are first met for CR or PR until recurrent or progressive disease is objectively documented.
Number of participants with adverse events as a measure of safety and tolerability of REOLYSIN when administered in combination with paclitaxel and carboplatin.
Time frame: Within 30 days of the last dose of REOLYSIN.
Compare Best % Tumor Specific Response in loco-regional disease and/or metastatic disease for the treatment regimens in the study population
Time frame: Assessed every 6 weeks until disease progression or death.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2014.
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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.
James A Bonner, MD principal investigator
University of Alabama at Birmingham, Birmingham, AB, US
Kevin Harrington, MBBS MRCP FRCR principal investigator
The Royal Marsden Hospital, London, UK
Jan Vermorken, MD, PhD principal investigator
University Hospital, Antwerp, Belgium
77 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing REOLYSIN, Carboplatin and Paclitaxel in people with Carcinoma, Squamous Cell of the Head and Neck, run by Oncolytics Biotech at 77 sites in 13 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 10 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 5 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 77 sites in United States, Russia, United Kingdom, Spain, Hungary and 8 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Overall survival (time frame: every 3 months until death.). 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 5 Nov 2014.