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Efficacy Study of REOLYSIN® in Combination With Paclitaxel and Carboplatin in Platinum-Refractory Head and Neck Cancers

Primary Purpose

Carcinoma, Squamous Cell of the Head and Neck

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
REOLYSIN
Carboplatin
Paclitaxel
Placebo
Sponsored by
Oncolytics Biotech
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Squamous Cell of the Head and Neck focused on measuring carcinoma, squamous cell, head, neck, REOLYSIN (Reovirus Type 3 Dearing), chemotherapy, Carboplatin, Paclitaxel, metastatic, recurrent

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Each patient MUST:

  • 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.
  • 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.

Exclusion Criteria: No patient may:

  • 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.

Sites / Locations

  • University of Alabama at Birmingham
  • Arizona Oncology Associates
  • Providence Health and Services
  • Wilshire Oncology Medical Group
  • BMS Physician Practice, A Medical Corporation DBA Medical Oncology Care Associates
  • Rocky Mountain Cancer Centers
  • Pasco Hernando Oncology Associates, PA
  • Emory University - Winship Cancer Institute
  • Alexian Brothers Hospital Network
  • Mary Bird Perkinds Cancer Center - Baton Rouge
  • Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
  • Dana-Farber Cancer Institute
  • Comprehensive Cancer Centers of Nevada
  • Montefiore Medical Center
  • Case Comprehensive Cancer Center, University Hospitals Case Medical Center
  • Mercy Cancer Center
  • Medical University of South Carolina
  • Texas Oncology- Sammons Cancer Center
  • Cancer Therapy and Research Center at UTHSCSA
  • Texas Oncology - Tyler
  • Columbia Basin Hematology and Oncology
  • ZNA Middelheim
  • University Hospital Antwerp
  • Universitair Ziekenhuis Brussel
  • Tom Baker Cancer Centre
  • Juravinski Cancer Center
  • London Health Sciences Centre
  • Hopital Notre-Dame
  • Hopital Saint-André / Service d'Oncologie-Radiothérapie
  • Centre Antoine Lacassagne / Oncologie Médicale
  • Institut Curie / Département d'Oncologie Médicale
  • UKE Hamburg
  • Attikon University Hospital
  • Fovarosi Onkormanyzat Uzsoki Utcai Kórház
  • Orszagos Onkologiai Intezet
  • Pecsi Tudomanyegyetem
  • Szegedi Tudományegyetem
  • Markusovszky Korhaz
  • Ufficio Sperimentazioni Cliniche c/o S.C. Oncologia Medica
  • Fondazione IRCCS Istituto Nazionale del Tumori
  • Ospedale San Paolo - Oncologia Medica
  • University Hospital in Modena
  • Centrum Onkologii - Instytyt im.M.Skłodowskiej-Curie
  • Szpital MSWiA - Centrum Onkologi
  • Wielkopolskie Centrum Onkologii
  • Wojewódzki Szpital Specjalistyczny im. M.Kopernika
  • State Health Care Institution "Arkhangelsk Regional Clinical Oncology Dispensary"
  • Regional State Health Care Institution "Belgorod Oncology Dispensary"
  • State Health Care Institution "Chelyabinsk Regional Oncology Dispensary"
  • State Health Care Institution "Republican Clinical Oncology Dispensary of Ministry of Health of the Republic of Tatarstan"
  • State Budgetary Health Care Institution "Clinical Oncology Dispensary #1" of Krasnodar Region Health Care Department
  • Regional Budgetary Health Care Institution "Kursk Regional Oncology Dispensary" of Health Care Committee of Kursk region
  • Federal State Budgetary Institution "Medical Research Radiology Center" of Ministry of Public Health and Social Development of Russian Federation, Obninsk
  • Federal State Budgetary Institution "Russian Research Centre of Radiology and Surgery technologies" of Ministry of Public Health and Social Development of the Russian Federation
  • Federal State Budgetary Institution "N. N. Petrov Oncology Research Institute" of Ministry of Public Health and Social Development of the Russian Federation
  • St.Petersburg State Health Care Institution City Clinical Oncology Dispensary"
  • State Health Care Institution "Oncology Dispensary №2" of Krasnodar Region Health Care Department
  • State Health Care Institution "Tula Regional Oncology Dispensary"
  • State Budgetary Healthcare Institution "Republic Clinical Oncology Dispensary Ministry of Health of Bashkortostan"
  • State Budgetary Health Care Institution of the Yaroslavl region "Regional Clinical Oncological Hospital"
  • Institute of Oncology Ljubljana
  • Hospital Vall D'Hebron
  • Instituto Catlan de Oncologia (ICO) - Hospital Duran i Reynals
  • Hospital Clinic i Provincial de Barcelona
  • Hospital Santa Creu I Sant Pau
  • Instituto Catlan de Oncologia (ICO) - Hospital Germans Trias I Pujol
  • Hospital de Basurto
  • Hospital de Navarra
  • Beatson West of Scotland Cancer Center
  • Royal Surrey County Hospital
  • St. James's University Hospital
  • Guy's and St. Thomas Hospital
  • The Royal Marsden Cancer Center, Fulham Road branch
  • The Royal Marsden Cancer Center, Sutton Branch
  • Musgrove Park Hospital
  • The Velindre Hospital
  • Clatterbridge Centre for Oncology NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

REOLYSIN, paclitaxel, carboplatin

placebo, paclitaxel, carboplatin

Arm Description

Outcomes

Primary Outcome Measures

Overall survival

Secondary Outcome Measures

Progression-free survival
Objective response (complete response (CR) + partial response (PR)) rate and duration
Number of participants with adverse events as a measure of safety and tolerability of REOLYSIN when administered in combination with paclitaxel and carboplatin.
Compare Best % Tumor Specific Response in loco-regional disease and/or metastatic disease for the treatment regimens in the study population

Full Information

First Posted
July 13, 2010
Last Updated
November 3, 2014
Sponsor
Oncolytics Biotech
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1. Study Identification

Unique Protocol Identification Number
NCT01166542
Brief Title
Efficacy Study of REOLYSIN® in Combination With Paclitaxel and Carboplatin in Platinum-Refractory Head and Neck Cancers
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oncolytics Biotech

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Squamous Cell of the Head and Neck
Keywords
carcinoma, squamous cell, head, neck, REOLYSIN (Reovirus Type 3 Dearing), chemotherapy, Carboplatin, Paclitaxel, metastatic, recurrent

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
167 (Actual)

8. Arms, Groups, and Interventions

Arm Title
REOLYSIN, paclitaxel, carboplatin
Arm Type
Active Comparator
Arm Title
placebo, paclitaxel, carboplatin
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
REOLYSIN
Other Intervention Name(s)
reovirus serotype 3 Dearing Strain
Intervention Description
3E10 TCID50, 1 hour intravenous infusion, administered on Days 1, 2, 3, 4 and 5 of a 21 day cycle
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
5 AUC mg/mL min, 30 min intravenous infusion, given on Day 1 of a 21 day cycle
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
175 mg/m2, 3 hour intravenous infusion, given on Day 1 of a 21 day cycle
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Overall survival
Time Frame
every 3 months until death.
Secondary Outcome Measure Information:
Title
Progression-free survival
Time Frame
Assessed every 6 weeks until disease progression or death.
Title
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.
Title
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.
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Each patient MUST: 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. 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. Exclusion Criteria: No patient may: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James A Bonner, MD
Organizational Affiliation
University of Alabama at Birmingham, Birmingham, AB, US
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kevin Harrington, MBBS MRCP FRCR
Organizational Affiliation
The Royal Marsden Hospital, London, UK
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jan Vermorken, MD, PhD
Organizational Affiliation
University Hospital, Antwerp, Belgium
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Arizona Oncology Associates
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85715
Country
United States
Facility Name
Providence Health and Services
City
Burbank
State/Province
California
ZIP/Postal Code
91505
Country
United States
Facility Name
Wilshire Oncology Medical Group
City
Corona
State/Province
California
ZIP/Postal Code
92879
Country
United States
Facility Name
BMS Physician Practice, A Medical Corporation DBA Medical Oncology Care Associates
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Rocky Mountain Cancer Centers
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Pasco Hernando Oncology Associates, PA
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
Emory University - Winship Cancer Institute
City
Altanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Alexian Brothers Hospital Network
City
Elk Grove Village
State/Province
Illinois
ZIP/Postal Code
60007
Country
United States
Facility Name
Mary Bird Perkinds Cancer Center - Baton Rouge
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
59169
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Case Comprehensive Cancer Center, University Hospitals Case Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Mercy Cancer Center
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Texas Oncology- Sammons Cancer Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Cancer Therapy and Research Center at UTHSCSA
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Texas Oncology - Tyler
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
Facility Name
Columbia Basin Hematology and Oncology
City
Kennewick
State/Province
Washington
ZIP/Postal Code
99336
Country
United States
Facility Name
ZNA Middelheim
City
Antwerpen
Country
Belgium
Facility Name
University Hospital Antwerp
City
Edegem
Country
Belgium
Facility Name
Universitair Ziekenhuis Brussel
City
Jette
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Tom Baker Cancer Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
Juravinski Cancer Center
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
Hopital Notre-Dame
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada
Facility Name
Hopital Saint-André / Service d'Oncologie-Radiothérapie
City
Bordeaux
ZIP/Postal Code
33075
Country
France
Facility Name
Centre Antoine Lacassagne / Oncologie Médicale
City
Nice
ZIP/Postal Code
06189
Country
France
Facility Name
Institut Curie / Département d'Oncologie Médicale
City
Paris
ZIP/Postal Code
75248
Country
France
Facility Name
UKE Hamburg
City
Hamburg
Country
Germany
Facility Name
Attikon University Hospital
City
Athens
Country
Greece
Facility Name
Fovarosi Onkormanyzat Uzsoki Utcai Kórház
City
Budapest
Country
Hungary
Facility Name
Orszagos Onkologiai Intezet
City
Budapest
Country
Hungary
Facility Name
Pecsi Tudomanyegyetem
City
Pecs
Country
Hungary
Facility Name
Szegedi Tudományegyetem
City
Szegedi
Country
Hungary
Facility Name
Markusovszky Korhaz
City
Szombathely
Country
Hungary
Facility Name
Ufficio Sperimentazioni Cliniche c/o S.C. Oncologia Medica
City
Cuneo
Country
Italy
Facility Name
Fondazione IRCCS Istituto Nazionale del Tumori
City
Milan
Country
Italy
Facility Name
Ospedale San Paolo - Oncologia Medica
City
Milan
Country
Italy
Facility Name
University Hospital in Modena
City
Modena
Country
Italy
Facility Name
Centrum Onkologii - Instytyt im.M.Skłodowskiej-Curie
City
Krakow
Country
Poland
Facility Name
Szpital MSWiA - Centrum Onkologi
City
Olsztyn
Country
Poland
Facility Name
Wielkopolskie Centrum Onkologii
City
Poznań
Country
Poland
Facility Name
Wojewódzki Szpital Specjalistyczny im. M.Kopernika
City
Łódź
Country
Poland
Facility Name
State Health Care Institution "Arkhangelsk Regional Clinical Oncology Dispensary"
City
Arkhangelsk
Country
Russian Federation
Facility Name
Regional State Health Care Institution "Belgorod Oncology Dispensary"
City
Belgorod
Country
Russian Federation
Facility Name
State Health Care Institution "Chelyabinsk Regional Oncology Dispensary"
City
Chelyabinsk
Country
Russian Federation
Facility Name
State Health Care Institution "Republican Clinical Oncology Dispensary of Ministry of Health of the Republic of Tatarstan"
City
Kazan
Country
Russian Federation
Facility Name
State Budgetary Health Care Institution "Clinical Oncology Dispensary #1" of Krasnodar Region Health Care Department
City
Krasnodar
Country
Russian Federation
Facility Name
Regional Budgetary Health Care Institution "Kursk Regional Oncology Dispensary" of Health Care Committee of Kursk region
City
Kursk
Country
Russian Federation
Facility Name
Federal State Budgetary Institution "Medical Research Radiology Center" of Ministry of Public Health and Social Development of Russian Federation, Obninsk
City
Obninsk
Country
Russian Federation
Facility Name
Federal State Budgetary Institution "Russian Research Centre of Radiology and Surgery technologies" of Ministry of Public Health and Social Development of the Russian Federation
City
Saint Petersburg
Country
Russian Federation
Facility Name
Federal State Budgetary Institution "N. N. Petrov Oncology Research Institute" of Ministry of Public Health and Social Development of the Russian Federation
City
Saint-Petersburg
Country
Russian Federation
Facility Name
St.Petersburg State Health Care Institution City Clinical Oncology Dispensary"
City
Saint-Petersburg
Country
Russian Federation
Facility Name
State Health Care Institution "Oncology Dispensary №2" of Krasnodar Region Health Care Department
City
Sochi
Country
Russian Federation
Facility Name
State Health Care Institution "Tula Regional Oncology Dispensary"
City
Tula
Country
Russian Federation
Facility Name
State Budgetary Healthcare Institution "Republic Clinical Oncology Dispensary Ministry of Health of Bashkortostan"
City
Ufa
Country
Russian Federation
Facility Name
State Budgetary Health Care Institution of the Yaroslavl region "Regional Clinical Oncological Hospital"
City
Yaroslavl
Country
Russian Federation
Facility Name
Institute of Oncology Ljubljana
City
Ljubljana
Country
Slovenia
Facility Name
Hospital Vall D'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Instituto Catlan de Oncologia (ICO) - Hospital Duran i Reynals
City
Barcelona
ZIP/Postal Code
08908
Country
Spain
Facility Name
Hospital Clinic i Provincial de Barcelona
City
Barcelona
Country
Spain
Facility Name
Hospital Santa Creu I Sant Pau
City
Barcelona
Country
Spain
Facility Name
Instituto Catlan de Oncologia (ICO) - Hospital Germans Trias I Pujol
City
Barcelona
Country
Spain
Facility Name
Hospital de Basurto
City
Bilbao
Country
Spain
Facility Name
Hospital de Navarra
City
Pamplona
Country
Spain
Facility Name
Beatson West of Scotland Cancer Center
City
Glasgow
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Facility Name
Royal Surrey County Hospital
City
Guildford
ZIP/Postal Code
GU2 7WG
Country
United Kingdom
Facility Name
St. James's University Hospital
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Guy's and St. Thomas Hospital
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
The Royal Marsden Cancer Center, Fulham Road branch
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
The Royal Marsden Cancer Center, Sutton Branch
City
Sutton
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
Musgrove Park Hospital
City
Taunton
ZIP/Postal Code
TA1 5DA
Country
United Kingdom
Facility Name
The Velindre Hospital
City
Whitchurch
ZIP/Postal Code
CF14 2TL
Country
United Kingdom
Facility Name
Clatterbridge Centre for Oncology NHS Foundation Trust
City
Wirral
ZIP/Postal Code
CH634JY
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Efficacy Study of REOLYSIN® in Combination With Paclitaxel and Carboplatin in Platinum-Refractory Head and Neck Cancers

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