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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001791
Receipt No. R000002161
Scientific Title Multicenter Phase II Study of Combination Epitope Peptides with mFOLFOX6 in Advanced/metastatic Colorectal Cancer
Date of disclosure of the study information 2009/05/01
Last modified on 2018/03/30

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Basic information
Public title Multicenter Phase II Study of Combination Epitope Peptides with mFOLFOX6 in Advanced/metastatic Colorectal Cancer
Acronym Epitope Peptides with mFOLFOX6 for metastatic CRC
Scientific Title Multicenter Phase II Study of Combination Epitope Peptides with mFOLFOX6 in Advanced/metastatic Colorectal Cancer
Scientific Title:Acronym Epitope Peptides with mFOLFOX6 for metastatic CRC
Region
Japan

Condition
Condition Metastatic chemo naive colorectal cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To determine the efficacy and safety of the combination therapy with mFOLFOX6 and novel epitope peptides for unresectable chemo-naïve colorectal cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes the efficacy (response rate, time to progression)
Key secondary outcomes 1. Safety
2. Over all survival
3. Induction of immune responses
4. Progression free survival

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 HLA-A2402 positive
Interventions/Control_2 HLA-A2402 negative
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. Histological proven colorectal cancer
2. PS:0 to 1(ECOG performance status score)
3. One or more RECIST lesions
4. chemo-naive
5. Good function of critical organs
6. Suspect for more than 3 months alive
7. Written informed consents
Key exclusion criteria 1. Severe heart diseases
2. Wish for pregnancy
3. Active infection
4. Steroid or immunosuppressive therapy
5. Allergy for using epitope peptides
6. Mental and nervous disorder
7. Massive pleural or abdominal effusions
8. Peripheral nervous disorder
9. Diarrhea
10. Doctors opinion
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaaki Oka
Organization YAMAGUCHI UNIVERSITY GRADUATE SCHOOL OF MEDICINE
Division name Department of Digestive Surgery and Surgical Oncology
Zip code
Address 1-1-1 Minami-Kogushi, Ube, Yamaguchi 755-8505, Japan
TEL 0836-22-2264
Email hazama@yamaguchi-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shoichi Hazama
Organization YAMAGUCHI UNIVERSITY GRADUATE SCHOOL OF MEDICINE
Division name Department of Digestive Surgery and Surgical Oncology
Zip code
Address 1-1-1 Minami-Kogushi, Ube, Yamaguchi 755-8505, Japan
TEL 0836-22-2264
Homepage URL
Email hazama-jsgs@umin.ac.jp

Sponsor
Institute YAMAGUCHI UNIVERSITY GRADUATE SCHOOL OF MEDICINE
Department of Digestive Surgery and Surgical Oncology
Institute
Department

Funding Source
Organization Yamaguchi University
Tokyo University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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 山口大学大学院消化器・腫瘍外科学
(Department of Digestive Surgery and Surgical Oncology (Department of Surgery II), YAMAGUCHI UNIVERSITY GRADUATE SCHOOL OF MEDICINE)

Other administrative information
Date of disclosure of the study information
2009 Year 05 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://meetinglibrary.asco.org/content/113655-132
Number of participants that the trial has enrolled
Results
J Transl Med. 2014 Apr 30;12:108. doi: 10.1186/1479-5876-12-108.
2013 ASCO Annual Meeting
J Clin Oncol 31, 2013 (suppl; abstr 3006)
Oral Abstract Session, Developmental Therapeutics - Immunotherapy 
Abstract: 
We further performed a phase II trial to evaluate the benefit of the cancer vaccination in combination with oxaliplatin-based chemotherapy as first-line therapy. Methods: Ninety-six chemotherapy na&iuml;ve CRC pts were enrolled to evaluate primarily response rates (RR), and secondarily OS and PFS. Each of the five peptides (3 mg each) was mixed with 1.5 ml of IFA and subcutaneously administered weekly for 12 weeks and after then biweekly. Chemotherapy was performed simultaneously as mFOLFOX6 or XELOX with/without bevacizumab. All enrolled pts had received the therapy without knowing HLA-A status double-blindly, and the HLA genotype were key-opened at analysis point and then, the endpoints are evaluated between HLA-A*2402 positive and HLA-A*2402 negative group. Results: Between February 2009 and November 2012, a total of 96 pts were enrolled in this study. The cutoff date for the main analysis was January 31, 2013 (median duration of follow-up of 26.5months). mFOLFOX6 and XELOX were administered to 93 and 3 pts, respectively. Bevacizumab was used for 5 pts. RR, the primary study end point, was 61.5% (CR 1, PR 58, SD 33, PD 4). It seemed superior as compared to other reports. The median duration to reach the best responses (14 weeks; range 8-69) was surprisingly long and indicated the delayed effect of vaccination. PFS and OS were 8.2 m and 20.7 m, respectively. The HLA genotype will be key-opened at March 2013 and the endpoints will be presented between HLA-A*2402 positive and negative group at the meeting. Conclusions:  The phase II cancer vaccine therapy demonstrated the promising response, and warrants further clinical studies. Clinical trial information: UMIN000001791. 
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
2008 Year 12 Month 20 Day
Date of IRB
Anticipated trial start date
2009 Year 01 Month 01 Day
Last follow-up date
2015 Year 12 Month 01 Day
Date of closure to data entry
2018 Year 03 Month 31 Day
Date trial data considered complete
2018 Year 03 Month 31 Day
Date analysis concluded
2018 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2009 Year 03 Month 23 Day
Last modified on
2018 Year 03 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002161

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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