UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Multicenter Phese II Study of SOX plus Bevacizumab Therapy with Oxaliplatin Stop-and-Go Strategy and Oral S-1 plus Bevacizumab Maintenance Therapy in Advanced Colorectal CancerC
Title of the study (Brief title)	CCOG1002.1
Region	Japan

Condition
Condition	Unresectable metastatic or recurrent colorectal cancer
Classification by specialty	Gastroenterology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of SOX (S-1+L-OHP) plus bevacizumab therapy considering Oxaliplatin Stop-and-Go Strategy in Advanced Colorectal Cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	DDC ; Duration of disease control)
Key secondary outcomes	TTF;Time to treatment-failure, PFS;Progression free-survival, OS;Overall survival, RR;Response rate, Reintroduction rate of SOX+bavacizumab therapy, 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	(1)Initial therapy : SOX+bevacizumab therapy Bev : 7.5 mg/kg (90 min) L-OHP : 130 mg/m2 (120 min) S-1 : 80 - 120 mg/day (Day1-15) (2)Maintenance therapy : S-1+bevacizumab therapy Bev : 7.5 mg/kg (90 min) S-1 : 80 - 120 mg/day (Day1-15) (3)Reintroduced therapy : SOX+bevacizumab therapy
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) Histopathologically confirmed colorectal cancer. (2) Written informed consent. (3) Age of 20 years or older. (4) ECOG performance status 0-1. (5) Life expectancy greater than 3 months. (6) Measurable or evaluable disease (RECIST ver.1.1.). (7) Untreated colorectal cancer. (8) Unresectable advanced colorectal cancer patient who have received no treatment without operation. (9) Reccurent colorectal cancer patient who have received no treatment for reccurence. (10) Adequate organ function.
Key exclusion criteria	1) Previous history of severe drug-induced allergy. 2) Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers, and man who wish to become his partner pregnancy. 3) Uncontrolled infection. 4) Uncontrolled severe complications (Interstitial lung disease, pulmonary fibrosis, renal failure, liver failure, DM, hypertension, et al.). 5) Patient with symptomatic cardiovascular disease or asymptomatic disease. 6) Patient who have peripheral nerve disorder. 7) Patient who have severe diarrhea. 8) Massive pleural effusion or ascites that required drainage. 9) Brain metastasis 10) History of Interstitial lung disease. 11) History of active double cancer. 12) Systemic administration of steroid. 13) Contraindication of S-1, L-OHP, Bevacizumab. 14) Not appropriate for the study at the physician's assessment. 15) Patient receiving surgical procedure within 28days. 16) History of gastrointestinal perforation within 6 months. 17) Patient who have gastrointestinal ulcer or bleeding. 18) Diathesis of bleeding or coagulopathy. 19) History of thoromboembolitic disease. 20) Patient with untreated traumatic bone fracture. 21) Systemic administration of antiplatelet drug, aspirin, and NSAIDS. 22) History of hemoptysis. 23) Colorectal cancer with obstruction. 24) Peritoneum dissemination confirmed by imaging
Target sample size	40

Research contact person
Name of lead principal investigator	Goro Nakayama
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Gastroenterology
Address	65 Tsurumai-cho Showa-ku Nagoya-city Aichi Japan
TEL	(81)52-744-2253
Email	goro@med.nagoya-u.ac.jp

Public contact
Name of contact person	Miyuki Aoki
Organization	Chubu Clinical Oncology Group(CCOG)
Division name	Data center
Address	65 Tsurumai-cho, Showa-ku, Nagoya-city, Aichi, Japan
TEL	(81)52-744-2253
Homepage URL	http://www.med.nagoya-u.ac.jp/surgery2/scientific/ccog/
Email	goro@med.nagoya-u.ac.jp

Sponsor
Institute	Chubu Clinical Oncology Group
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
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	2013 Year 09 Month 08 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2010 Year 04 Month 01 Day
Anticipated trial start date	2010 Year 04 Month 04 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	2013 Year 09 Month 08 Day
Last modified on	2016 Year 11 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013519