UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase l and Phase ll Study of S-1+oxaliplatin (SOX)+cetuximab as first Line therapy in metastatic colorectal cancer with EGFR-detectable and KRAS wild type
Title of the study (Brief title)	JACCRO CC-06 study
Region	Japan

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

Objectives
Narrative objectives1	To determine MTD and RD in Phase I and to evaluate the efficacy and safety of TS-1+oxaliplatin+cetuximab as first line in metastatic colorectal cancer with EGFR-detectable and KRAS wild type
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I,II

Assessment
Primary outcomes	Phase I: Maximum Tolerated Dose, Recommended Dose Phase II: Response Rate
Key secondary outcomes	Phase I: Safety, Response Rate Phase II: Overall Survival, Progression Free Survival, Safety

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	S-1 +oxaliplatin (SOX) + cetuximab Cetuximab: loding dose 400 mg/m2, 250 mg/m2/week L-OHP: 75-130 mg/m2 tri-weekly S-1: 80 mg/m2 (80-120 mg/day)
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	79 years-old >=
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 (Age between 20 to 79 years in Phase I) 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	56

Research contact person
Name of lead principal investigator	Wataru Ichikawa
Organization	National Defense Medical College Hospital
Division name	Department of Clinical Oncology
Address	3-2 Namiki, Tokorozawa-shi, Saitama, Japan 359-8513
TEL	04-2995-1511
Email	wataru@ndmc.ac.jp

Public contact
Name of contact person	Wataru Ichikawa
Organization	National Defense Medical College Hospital
Division name	Department of Clinical Oncology
Address	3-2 Namiki, Tokorozawa-shi, Saitama, Japan 359-8513
TEL	04-2995-1511
Homepage URL	http://www.jaccro.com/
Email	wataru@ndmc.ac.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	Japan

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	防衛医科大学校病院（埼玉県）、埼玉医科大学国際医療センター（埼玉県）、神戸市立医療センター中央市民病院（兵庫県）、がん・感染症センター都立駒込病院（東京都）、岐阜大学医学部附属病院（岐阜県）、慈泉会相澤病院（長野県）、昭和大学横浜市北部病院（神奈川県）、駿河台日本大学病院（東京都）、千葉県がんセンター（千葉県）、日本大学医学部附属板橋病院（東京都）

Other administrative information
Date of disclosure of the study information	2012 Year 01 Month 06 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2011 Year 12 Month 13 Day
Anticipated trial start date	2012 Year 01 Month 01 Day
Last follow-up date	2016 Year 07 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 01 Month 06 Day
Last modified on	2016 Year 11 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008284