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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000007559
Receipt No. R000008928
Scientific Title A randomized phase II trial of adjuvant immunotherapy with alpha-GalactosylCeramide-pulsed dendritic cells for advanced oropharyngeal and hypopharyngeal cancer following standard therapy
Date of disclosure of the study information 2012/03/23
Last modified on 2012/03/23

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Basic information
Public title A randomized phase II trial of adjuvant immunotherapy with alpha-GalactosylCeramide-pulsed dendritic cells for advanced oropharyngeal and hypopharyngeal cancer following standard therapy
Acronym A randomized phase II trial of adjuvant immunotherapy with alpha-GalactosylCeramide-pulsed dendritic cells for advanced oropharyngeal and hypopharyngeal cancer following standard therapy
Scientific Title A randomized phase II trial of adjuvant immunotherapy with alpha-GalactosylCeramide-pulsed dendritic cells for advanced oropharyngeal and hypopharyngeal cancer following standard therapy
Scientific Title:Acronym A randomized phase II trial of adjuvant immunotherapy with alpha-GalactosylCeramide-pulsed dendritic cells for advanced oropharyngeal and hypopharyngeal cancer following standard therapy
Region
Japan

Condition
Condition Oropharyngeal and Hypopharyngeal squamous cell carcinoma
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To examine the efficacy of adjuvant immunotherapy with alpha-Galactosylceramide-pulsed dendritic cells for advanced oropharyngeal and hypopharyngeal cancer following standard therapy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes Relapse-free survival
Key secondary outcomes Two-year relapse rate
Overall survival rate
Specific immune responses of peripheral blood
Frequency and seriousness of adverse events

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Sub-mucosal administrations of alpha-GalactosylCeramide pulsed DCs are performed on day 7 and 10 after the entry.
Interventions/Control_2 Sub-mucosal administrations of non pulsed DCs are performed on day 7 and 10 after the entry.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria Patients with stage IV oropharyngeal and hypopharyngeal squamous cell carcinoma, who have achieved Complete Response after the standard treatment; Patients within 8 weeks after receiving the determination of Complete Response; Performance status 0-2; Normal bone marrow, liver and renal functions.
Key exclusion criteria Patients who have: uncontrolled diabetes mellitus, pulmonary fibrosis, and/or infection; a history of hepatitis; a positive response for hepatitis B surface antigen, or human immunodeficiency virus (HIV), hepatitis C virus, or human T-lymphotrophic virus antibodies; serious cardiac disease; recieived concurrent corticosteroid therapy; pregnancy or lactation; autoimmune diseases; been judged to be inappropriate to participate in this study by principle investigator or co-investigator
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshitaka Okamoto
Organization Graduate School of Medicine, Chiba University
Division name Department of Otorhinolaryngology, Head and Neck Surgery
Zip code
Address 1-8-1 Inohana, Chuo-ku, Chiba, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Daiju Sakurai
Organization Graduate School of Medicine, Chiba University
Division name epartment of Otorhinolaryngology, Head and Neck Surgery
Zip code
Address 1-8-1 Inohana, Chuo-ku, Chiba, Japan
TEL
Homepage URL
Email

Sponsor
Institute Department of Otorhinolaryngology, Head and Neck Surgery, Graduate School of Medicine, Chiba University
Institute
Department

Funding Source
Organization The Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2012 Year 03 Month 23 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2009 Year 07 Month 22 Day
Date of IRB
Anticipated trial start date
2009 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 03 Month 23 Day
Last modified on
2012 Year 03 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008928

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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