UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003556 |
|---|---|
| Receipt number | R000004283 |
| Scientific Title | Postoperative adjuvant immunochemotherapy of tumor specific peptide vaccine plus CDDP+5FU chemotherapy for esophageal cancer patients with pathological lymph node metastasis who underwent no preoperative treatment- Multicenter Phase II trial |
| Date of disclosure of the study information | 2010/05/03 |
| Last modified on | 2015/05/01 19:14:15 |
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Basic information
Public title
Postoperative adjuvant immunochemotherapy of tumor specific peptide vaccine plus CDDP+5FU chemotherapy for esophageal cancer patients with pathological lymph node metastasis who underwent no preoperative treatment- Multicenter Phase II trial
Acronym
Postoperative adjuvant tumor specific peptide vaccine plus FP chemotherapy for pN(+) esophageal cancer patients without preoperative therapy
Scientific Title
Postoperative adjuvant immunochemotherapy of tumor specific peptide vaccine plus CDDP+5FU chemotherapy for esophageal cancer patients with pathological lymph node metastasis who underwent no preoperative treatment- Multicenter Phase II trial
Scientific Title:Acronym
Postoperative adjuvant tumor specific peptide vaccine plus FP chemotherapy for pN(+) esophageal cancer patients without preoperative therapy
Region
| Japan |
Condition
Condition
esophageal cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This clinical trial is the multicenter phase II trial to evaluate the effect of HLA A2402-restricted epitope peptide derived from new tumor specific antigens of URLC10, CDCA1 and KOC1 about suppression of postoperative recuurrence for esophageal cancer patients with pathological lymph node metastasis who underwent no preoperative therapy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Relapse free Survival
Key secondary outcomes
Disease free survival
Overall survival
Adverse event
Feasibility
immunoresponse
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Vaccine |
Interventions/Control_1
Patients with HLA-A*2402 will undergo 2 set of weekly vaccination for 5 weeks followed by byweekly vaccinotion for 10 weeks in addition to standard therapy of 2 set of CDDP plus 5FU adjuvant chemotherapy. On each vaccination day, 1mg of the HLA-A*2402-restricted URLC10, CDCA1 and KOC1 peptide mixed with Montanide ISA 51 will be administered by subcutaneous injection.
Interventions/Control_2
Patients without HLA-A*2402 will undergo only standard therapy of 2 set of CDDP plus 5FU adjuvant chemotherapy.
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Patients with esophageal SCC who underwent currative (R0) resection without preoperative treatment and had pathological LN metastases
2)Laboratory values as follows
Hemoglobin > 8.0g/dL
2000/mm3 < WBC < 15000mm3
Platelet count > 70000/mm3
Total bilirubin < 1.5mg/dL
Asparate transaminase < 150U/L
Alanine transaminase < 150U/L
Serum creatinine < 3.0mg/dL
PaO2 > 70mmHg
3)ECOG performance status 0-1
4)Age between 20 to 84
5)Male and female
6)Able and willing to give valid written informed consent
Key exclusion criteria
1)Infectious disease (ex. patients with high fever of 38.5 degrees C or more, et cetra)
2)Severe heart disease or past history of the disease
3)Severe postoperative complications (ileus, interstitial pneumonia, uncontrolled DM, renal failure, cirrhosis, et cetra)
4)Severe mental disorder
5)Another active malignant disease
6)Brestfeeding and pregnancy (woman of child bearing potential)
7)Man with an intention to get with child
8)Autoimmune disease
9)Retention of pericardial fluid to cause heart failure or pericarditis
10)Decision of unsuitableness by principal investigator or physician-in-charge
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hitoshi Shiozaki |
Organization
Kinki University Faculty of Medicine
Division name
Department of Surgey
Zip code
Address
377-2, Ohno-Higashi, Osaka-sayama, Osaka, Japan
TEL
072-366-0221
shiozaki@itp.kindai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takushi Yasuda |
Organization
Kinki University Faculty of Medicine
Division name
Department of Surgey
Zip code
Address
377-2, Ohno-Higashi, Osaka-sayama, Osaka, Japan
TEL
072-366-0221
Homepage URL
tyasuda@surg.med.kindai.ac.jp
Sponsor or person
Institute
Kinki University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kinki University Faculty of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Human Genome Center, Institute of Medical Science, The University of Tokyo
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
近畿大学医学部附属病院 (Kinki University Faculty of Medicine)
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 05 | Month | 03 | 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
Terminated
Date of protocol fixation
| 2009 | Year | 11 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 01 | 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
| 2010 | Year | 05 | Month | 01 | Day |
Last modified on
| 2015 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004283
