UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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)".
Title of the study (Brief title)	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	Wataru Ichikawa
Organization	Showa University Fujigaoka Hospital
Division name	Division of Medical Oncology and Palliative Medicine
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	Masashi Fujii
Organization	Japan Clinical Cancer Research Organization
Division name	Office
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 03 Month 06 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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