UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027014
Receipt No. R000030974
Scientific Title The follow up study of "Phase l / ll Study of S-1+oxaliplatin (SOX)+cetuximab as first Line therapy in metastatic colorectal cancer with EGFR-detectable and KRAS wild type (JACCRO CC-06)".
Date of disclosure of the study information 2017/04/18
Last modified on 2019/03/08

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title The follow up study of "Phase l / ll Study of S-1+oxaliplatin (SOX)+cetuximab as first Line therapy in metastatic colorectal cancer with EGFR-detectable and KRAS wild type (JACCRO CC-06)".
Acronym JACCRO CC-06 B
Scientific Title The follow up study of "Phase l / ll Study of S-1+oxaliplatin (SOX)+cetuximab as first Line therapy in metastatic colorectal cancer with EGFR-detectable and KRAS wild type (JACCRO CC-06)".
Scientific Title:Acronym JACCRO CC-06 B
Region
Japan

Condition
Condition metastatic colorectal cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study to evaluate the overall survival of the patients with EGFR positive and KRAS wild type who registered JACCRO CC-06 study treated by S-1/Oxaliplatin/cetuximab.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Overall Survival (OS)
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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 histologically proven colorectal cancer.
(2) Metastatic colorectal cancer with EGFR expressed.
(3) KRAS wild type in codon 12, 13.
(4) Presence of measurable lesion (RECIST Ver.1.) .
(5) No prior chemotherapy for unresectable primary tumor, metastases and lymph node metastasis. No primar therapy including surgery for recurrent that should be the first relapse after surgery for primary or metastases tumors.
(6) ECOG Performance Status (PS) 0-1.
(7) Age over 20 years.
(8) Life expectancy of more than 3 months.
(9) Oral food intake possible.
(10) Patients have enough organ function for study treatment.
(11) Written informed consent.
Key exclusion criteria (1) Synchronous multiple malignancy or metachronous multiple malignancy within 5 years disease free interval.
(2) Symptomatic brain metastases.
(3) Severe infectious disease.
(4) Interstitial lung disease or pulmonary fibrosis.
(5) Comorbidity or history of heart failure.
(6) Sensory alteration or paresthesia interfering with function.
(7) Large quantity of pleural, abdominal or cardiac effusion.
(8) Severe comorbidity (renal failure, liver failure, hypertension, etc).
(9) Prior radiotherapy for primary and metastases tumors.
(10) Men/women who are unwilling to avoid pregnancy. Women who are pregnant or breastfeeding. Women with a positive pregnancy test.
(11) History of severe allergy.
(12) History of allergy for L-OHP and other platinating agent.
(13) Prior treatment of cetuximab or L-OHP or TS-1.
(14) Administration of flucytosine.
(15) Any other cases who are regarded as inadequate for study enrollment by investigators.
Target sample size 33

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Wataru Ichikawa
Organization Showa University Fujigaoka Hospital
Division name Division of Medical Oncology and Palliative Medicine
Zip code
Address 1-30 Fujigaoka, Aoba-ku, Yokohama-shi, Kanagawa 224-8503, Japan
TEL 045-971-1151
Email wataru@med.showa-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masashi Fujii
Organization Japan Clinical Cancer Research Organization
Division name Office
Zip code
Address 1-14-5 Ginza, Chuo-ku, Tokyo 104-0061, Japan
TEL 03-5579-9882
Homepage URL
Email cc06.dc@jaccro.or.jp

Sponsor
Institute Japan Clinical Cancer Research Organization
Institute
Department

Funding Source
Organization Japan Clinical Cancer Research Organization
Organization
Division
Category of Funding Organization Non profit foundation
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 神戸市立医療センター中央市民病院(愛知県)、昭和大学横浜市北部病院(神奈川県)、岡山ろうさい病院(岡山県)、埼玉医科大学国際医療センター(埼玉県)、千葉県がんセンター(千葉県)、医療法人薫風会佐野病院(兵庫県)、近畿大学医学部奈良病院(奈良県)、一般財団法人甲南会甲南病院(兵庫県)、高知医療センター(高知県)、神戸大学医学部附属病院(兵庫県)、日本大学医学部附属板橋病院(東京都)、函館五稜郭病院(北海道)、姫路赤十字病院(兵庫県)、兵庫県立がんセンター(兵庫県)

Other administrative information
Date of disclosure of the study information
2017 Year 04 Month 18 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
2017 Year 03 Month 06 Day
Date of IRB
Anticipated trial start date
2017 Year 04 Month 10 Day
Last follow-up date
2017 Year 06 Month 15 Day
Date of closure to data entry
2017 Year 06 Month 30 Day
Date trial data considered complete
2017 Year 10 Month 01 Day
Date analysis concluded
2017 Year 10 Month 11 Day

Other
Other related information The median survival time (MST) is not reached, because the 33 of the 59 patients who enrolled JACCRO CC-06 study is still alive at the end of the planned follow-up period of 2 years. We planned additional follow up of these patients to complete the actual MST.

Management information
Registered date
2017 Year 04 Month 17 Day
Last modified on
2019 Year 03 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030974

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.