UMIN-CTR Clinical Trial

Basic information
Public title	Phase II study of FOLFIRI + cetuximab as induction chemotherapy followed by FOLFIRI + bevacizumab based on early tumor shrinkage in chemotherapy-naive patients with RAS wild-type colorectal cancer
Acronym	Phase II study of FOLFIRI + cetuximab as induction chemotherapy followed by FOLFIRI + bevacizumab based on early tumor shrinkage in chemotherapy-naive patients with RAS wild-type colorectal cancer
Scientific Title	Phase II study of FOLFIRI + cetuximab as induction chemotherapy followed by FOLFIRI + bevacizumab based on early tumor shrinkage in chemotherapy-naive patients with RAS wild-type colorectal cancer
Scientific Title:Acronym	Phase II study of FOLFIRI + cetuximab as induction chemotherapy followed by FOLFIRI + bevacizumab based on early tumor shrinkage in chemotherapy-naive patients with RAS wild-type colorectal cancer
Region	Japan

Condition
Condition	Colorectal cancer
Classification by specialty	Gastroenterology Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of FOLFIRI + cetuximab as induction chemotherapy followed by FOLFIRI + bevacizumab based on early tumor shrinkage in chemotherapy-naive patients with RAS wild-type colorectal cancer
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Progression free survival (PFS)
Key secondary outcomes	early tumor shrinkage(ETS) rate PFS of ETS positive and negative depth of response(DpR) Time to DpR time to treatment failure(TTF) response rate overall 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	ETS was defined as 20% or more tumor reduction at 8 weeks. Patients with ETS after 8 weeks from the treatment start date continued FOLFIRI + Cmab as induction to 16 weeks, and switched to FOLFIRI +BV for maintenance of progressive disease. Patients without ETS at 8 weeks immediately switched to FOLFIRI+BV to control progression. FOLFIRI+Cmab induction therapy; Cetuximab: 250mg/m2day1 day1, 8(1cours day1:400mg/m2), CPT-11: 180mg/m2 day1, l-LV: 200mg/m2 day1, 5-FU bolus: 400mg/m2 day1, 5-FU infusion: 2400mg/m2 day1-2 FOLFIRI+BV maintenance therapy; Bevacizumab: 5mg/kg day1, CPT-11: 180mg/m2 day1, l-LV: 200mg/m2 day1, 5-FU bolus: 400mg/m2 day1, 5-FU infusion: 2400mg/m2 day1-2
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) Histologically proven adenocarcinoma of colorectal cancer 2) Unresectable/recurrence colorectal cancer, no prior chemotherapy 3) RAS wild type 4) >= 20 years old 5) Measurable lesion according to RECIST (Ver.1.1) 6) ECOG performance status (PS) 0-2 7) Adequate organ function 8) Life expectancy of more than 90 days 9) Written informed consent
Key exclusion criteria	1) Previous treatment with irinotecan, bevacizumab, cetuximab/panitumumab 2) Symptomatic brain metastasis 3) Intestinal paralysis/obstruction 4) Massive pleural effusion, ascites, or pericardial effusion 5) Uncontrolled diarrhea 6) Active synchronous or metachronous malignancy 7) Severe infectious disease 8) Grade2 or higher skin toxicity 9) Interstitial pneumonia or pulmonary fibrosis 10) Serious complication(uncontrolled diabetes, severe cardiac disease, renal failure, liver failure) 11) History of thromboembolism 12) Unhealed wounds 13) Previous treatment with radiotherapy for primary disease 14) Administration of aspirin 15) Carcinomatous meningitis, uncontrolled epilepsy, mental disorder 16) Systemic administration of steroid 17) History of severe allergy 18) Positive for HBs antigen 19) Women who are pregnant or patients who are unwilling to avoid pregnancy 20) Patients who are inappropriate for the study in the opinion of the investigator
Target sample size	54

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Takako Eguchi Nakajima
Organization	St. Marianna University School of Medicine
Division name	Department of Clinical Oncology
Zip code
Address	2-16-1 sugao miyamae-ku kawasaki kanagawa
TEL	044-977-8111
Email	tnakajima@marianna-u.ac.jp

Public contact
1st name of contact person	1st name Middle name Last name Takashi Tsuda
Organization	St. Marianna University School of Medicine
Division name	Department of Clinical Oncology
Zip code
Address	2-16-1 sugao miyamae-ku kawasaki kanagawa
TEL	044-977-8111
Homepage URL
Email	tatsuda@marianna-u.ac.jp

Sponsor
Institute	Department of Clinical Oncology, St. Marianna University School of Medicine
Institute
Department

Funding Source
Organization	Department of Clinical Oncology, St. Marianna University School of Medicine
Organization
Division
Category of Funding Organization	Self funding
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

Other administrative information
Date of disclosure of the study information	2016 Year 08 Month 01 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	Terminated
Date of protocol fixation	2016 Year 08 Month 12 Day
Date of IRB	2016 Year 08 Month 12 Day
Anticipated trial start date	2016 Year 10 Month 07 Day
Last follow-up date	2018 Year 12 Month 21 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 07 Month 05 Day
Last modified on	2019 Year 03 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026538