UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007559 |
|---|---|
| Receipt number | 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 15:45:19 |
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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
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
Sponsor or person
Institute
Department of Otorhinolaryngology, Head and Neck Surgery, Graduate School of Medicine, Chiba University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008928
