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

Email

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


Email

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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name