UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase I study of 5-FU + Oxaliplatin + Irinotecan + Levofolinate + Panitumumab as the first-line therapy in patients with KRAS or RAS wild-type metastatic colorectal cancer
Title of the study (Brief title)	JACCRO CC-14 study
Region	Japan

Condition
Condition	KRAS or RAS wild-type metastatic colorectal cancer
Classification by specialty	Gastroenterology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To determin MTD and RD of 5-FU + Oxaliplatin + Irinotecan + Levofolinate + Panitumumab as the first-line therapy in patients with KRAS or RAS wild-type metastatic colorectal cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I

Assessment
Primary outcomes	Recommended Dose
Key secondary outcomes	Completion rate of the protocol treatment (Until 12 courses) Time to Treatment Failure Overall Survival Progression Free Survival Safety Response Rate

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	FOLFOXIRI+Panitumumab (Until 12 courses) Panitumumab 6mg/kg/bi-weekly Irinotecan 165-125mg/m2/bi-weekly Oxaliplatin 85mg/m2/bi-weekly Levofolinate 200mg/m2/bi-weekly 5-FU 3200mg/m2/bi-weekly
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	(1) Histologically confirmed colorectal cancer (Adenocarcinoma). (2) KRAS wild-type, or RAS wild-type. (3) Presence of evaluable lesion. (4) No prior chemotherapy or radiotherapy for unresectable primary tumor, metastases and lymphnode metastases. No prior therapy including surgery for reccurent lesions that should be the first relapse after surgery for primary or metastases tumors. (5) Age; more than 18 years old. (6) ECOG Performance status 0-1. (7) UGT1A1*6*28 wild type or single hetero. (8) Life expectancy of more than 3 months.(9) Patients have enough organ function for study treatment within 14 days before enrollment; 1) WBC>= 3,000/mm3, <12,000/mm3. 2) Neu>= 2,000/mm3. 3) PLT>= 100,000/mm3. 4) Hb>= 10.0g/dL. 5) Total Bilirubin<= 1.5mg/dL. 6) AST<= 100IU/L. 7) ALT<= 100IU/L. 8) Creatinine<= 1.5mg/dL. (10) Written informed consent.
Key exclusion criteria	(1) Synchronous multiple malignancy or metachronous multiple malignancy within 5 years disease free interval. (2) Administration of blood products/ G-CSF, and blood transfusion within 14 days. (3) Brain metastases. (4) Active infection. (5) Serious complication (Interstitial pneumonia, Chronic obstructive pulmonary, Idiopathic pulmonary fibrosis, Renal failure, Hepatic failure, Uncontrolled Deabetes, Uncontrolled hypertention, Angina requiring treatment, Cardiac failure, Jaundice). (6) Ileus or bowel obstruction. (7) Large quantity of pleural, abdominal or cardiac effusion. (8) diarrhea. (9) peripheral neuropathy greater than Grade 2. (10) Active viral hepatitis. (11) Administration of atazanavir sulfate. (12) History of severe allergy. (13) History of organ recipient. (14) History of myocardial infarction, unstable angina within 3 months prior to the registration. (15) Prior Panitumumab/Irinotecan/Oxaliplatin treatment. (Adjuvant therapy by Oxaliplatin is excluded) (16) severe mental disorders. (17) Systemic steroid user. (18) Men/women who are unwilling to avoid pregnancy. Women who are pregnant or breastfeeding. Women with a positive pregnancy test. (19) Any other cases who are regarded as inadequate for study enrollment by investigators.
Target sample size	18

Research contact person
Name of lead principal investigator	Akihito Tsuji
Organization	Kobe City Medical Center General Hospital
Division name	Clinical oncology
Address	Clinical oncology
TEL	078-302-4321
Email	tsuji@kcho.jp

Public contact
Name of contact person	Masashi Fujii
Organization	Nonprofit 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	cc14.dc@jaccro.or.jp

Sponsor
Institute	Nonprofit Organization Japan Clinical Cancer Research Organization
Institute
Department

Funding Source
Organization	Takeda Pharmaceutical Company Limited
Organization
Division
Category of Funding Organization	Profit organization
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

Other administrative information
Date of disclosure of the study information	2014 Year 11 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 10 Month 16 Day
Anticipated trial start date	2014 Year 11 Month 01 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	Published
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 10 Month 20 Day
Last modified on	2018 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=R000017987