UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007905 |
|---|---|
| Receipt number | R000009311 |
| Scientific Title | A randomized multicenter trial of adjuvant IMF-001 after curative resection for esophageal cancer with NY-ESO-1 antigen (phase II study) |
| Date of disclosure of the study information | 2012/05/14 |
| Last modified on | 2018/05/14 18:13:31 |
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Basic information
Public title
A randomized multicenter trial of adjuvant IMF-001 after curative resection for esophageal cancer with NY-ESO-1 antigen (phase II study)
Acronym
A randomized multicenter trial of adjuvant IMF-001 after curative resection for esophageal cancer with NY-ESO-1 antigen (phase II study)
Scientific Title
A randomized multicenter trial of adjuvant IMF-001 after curative resection for esophageal cancer with NY-ESO-1 antigen (phase II study)
Scientific Title:Acronym
A randomized multicenter trial of adjuvant IMF-001 after curative resection for esophageal cancer with NY-ESO-1 antigen (phase II study)
Region
| Japan |
Condition
Condition
Patients after curative resection for esophageal cancer with NY-ESO-1 antigen expression
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To assess the disease-free survival and the safety of repeated doses of IMF-001.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Disease-free survival
Safety
Key secondary outcomes
Overall survival
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Vaccine |
Interventions/Control_1
IMF-001-treated group:
IMF-001 0.2mg will be administered 6 times every 2 weeks, and 9 times every 4 weeks.
Interventions/Control_2
IMF-001-untreated group:
IMF-001 is not administered.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients with esophageal squamous cell carcinoma, which is histologically or cytologically confirmed.
2) Tumor cells are judged expressing NY-ESO-1 antigen by immunohistochemistry.
3) Preoperative chemotherapy with regimen containing fluoropyrimidine and platinum.
4) Patients underwent esophagectomy with 2 or 3-field lymphadenectomy (R0-resection : UICC).
5) Clinical stage is either II or III or IV with supraclavicular lymph node metastasis (UICC Ver.7) .
6) Trial dosing is started within 12 weeks after resection.
7) Patients should be 20 years or older at enrollment.
8) No serious disorder of major organs (bone marrow, heart, lung, liver and kidney) and meet the following conditions ;
WBC count : >=2,000/mm3
Hemoglobin : >=8.0g/dL
Platelet count : >=75,000/mm3
Serum total bilirubin : <=1.5 x ULN
AST and ALT : <=2.5 x ULN
Serum creatinine : <=2 x ULN
9) Agree to use birth control including condom etc. from the time of obtaining the first consent to 6 months after the final administration of the study drug (except female after menopause (1 year or more after the last menstruation) and female/male after the operation for sterilization).
10) Given written informed consent.
Key exclusion criteria
1) Patients undergoing treatment with radiotherapy for esophageal cancer.
2) Patients with double cancer.
3) Patients with autoimmune disease.
4) HIV antibody positive.
5) History of serious anaphylaxis.
6) Within 4 weeks after treatment with immune suppressant, immune enhancer or systemically administered adrenocorticosteroid.
7) Pregnant or breast-feeding females and females who have a possibility of pregnancy.
8) Patients who are administered the other investigational product within 12 weeks of the secondary entry.
9) Any other inadequacy for this study.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinichi Kageyama, M.D., Ph.D. |
Organization
Mie University Graduate School of Medicine
Division name
Department of Immuno-gene Therapy
Zip code
Address
2-174, Edobashi, Tsu-city, Mie 514-8507 Japan
TEL
059-231-5397
kageyama@clin.medic.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Miyamoto |
Organization
Secretariat of clinical trial coordinating committee
Division name
(none)
Zip code
Address
Chiyoda-BLDG east, 2-9-4, Higashitenma, Kita-ku, Osaka 530-0044 Japan
TEL
06-6358-7110
Homepage URL
imf001_sec@fiverings.co.jp
Sponsor or person
Institute
Department of Immuno-gene Therapy, Mie University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
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 | 05 | Month | 14 | 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
Completed
Date of protocol fixation
| 2012 | Year | 02 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 12 | Month | 07 | Day |
Date trial data considered complete
| 2017 | Year | 12 | Month | 07 | Day |
Date analysis concluded
| 2017 | Year | 12 | Month | 25 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 05 | Month | 08 | Day |
Last modified on
| 2018 | Year | 05 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009311
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