UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The efficacy and safety of perioperative chemotherapy for locally advanced colorectal cancer. - The phase II study-
Title of the study (Brief title)	The efficacy and safety of perioperative chemotherapy for locally advanced colorectal cancer. - The phase II study-
Region	Japan

Condition
Condition	locally advanced colorectal cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To assess the efficacy and the safety of first line chemotherapy for locally advanced colorectal cancer with RAS wild and mutation type.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Response rate (judged by enhanced CT and MRI on 12 weeks after initiation of chemotherapy)
Key secondary outcomes	Induction rate of curative operation, Overall survival, Relapse free survival. Incidence rate of complication

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine Maneuver
Interventions/Control_1	1) All RAS wild-type: 6 courses of cetuximab+mFOLFOX6 or 4 courses of cetuximab+SOX is performed, followed by curative operarion. 2) All RAS mutant-type: 6 courses of FOLFOXIRI or SOXIRI is performed, followed by curative operation.
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	85 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Written informed consent 2) Investigator determines that the appropriate 3) Histologically confirmed colorectal cancer(Excluding the appendix) 4) RAS wild-type or mutant. 5) With measurable lesion 6) Irinotecan case of use UGT1A1 *6 *28 is a wild type or single hetero. 7) Without chemotherapy history (Including the hepatic arterial infusion / radiation therapy). However, with regard to the post-operative adjuvant chemotherapy, to be registered if it passed more than 6 months from the end of treatment. 8) Performance Status (ECOG) 0-2 (Possible outpatient treatment) 9) Age over 20 years 10) Survival period more than 3 months 11) Adequate organ function (Inspection of within 14 days before) 1. WBC: >=3000/mm3 and 12,000/mm3 2. Neutrophil: >=1,500/mm3 3. Platelet: >=100,000/mm3 4. Hemoglobin: >=9.0g/dL 5. T Bil: <=2.0mg/dL 6. AST,ALT: <100IU/L 7. Serum creatinine: <=1.5mg/dL 12) With ability of oral intake
Key exclusion criteria	1) Patients with severe drug allergy (hypersensitivity) 2) Clinical problem infection 3) Liver dysfunction (jaundice) / Severe renal dysfunction 4) Uncontrolled high blood pressure, Diabetes, Hypercalcemia 5) Severe lung disease (Interstitial pneumonia, Pulmonary fibrosis, Advanced emphysema, etc) 6) Patient who need drainage of peritoneal, pleural or pericardial effusion. 7) Brain metastases (Diarrhea a hindrance to daily life in the patient who has a colostomy) 8) Diarrhea (watery stool) 9) Hepatitis B / C virus-positive
Target sample size	35

Research contact person
Name of lead principal investigator	Katsuji Tokuhara, MD
Organization	Kansai Medical University Medical Center
Division name	Department of Surgery
Address	10-15 Fumizono-cho, Moriguchi Osaka, 570-8507, Japan
TEL	06-6992-1001
Email	tokuhark@takii.kmu.ac.jp

Public contact
Name of contact person	Katsuji Tokuhara, MD
Organization	Kansai Medical University Medical Center
Division name	Department of Surgery
Address	10-15 Fumizono-cho, Moriguchi Osaka, 570-8507, Japan
TEL	06-6992-1001
Homepage URL
Email	tokuhark@takii.kmu.ac.jp

Sponsor
Institute	Kansai Medical University Medical Center
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
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

Other administrative information
Date of disclosure of the study information	2016 Year 10 Month 06 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 09 Month 26 Day
Anticipated trial start date	2016 Year 09 Month 26 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2016 Year 10 Month 06 Day
Last modified on	2016 Year 10 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027398