UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II trial of mFOLFOX6/XELOX plus bevacizumab with oxaliplatin in a stop and go fashion in advanced metastatic colorectal cancer
Title of the study (Brief title)	J-M-CONcePT trial phase II study(T-CORE0901)
Region	Japan

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

Objectives
Narrative objectives1	Primary endpoint is to evaluate median progression free survival (PFS) of modified FOLFOX6 with oxaliplatin in stop and go fasshion in unresectabel advanced or recurrence colorectal cancer patients with RECIST-based mesurable disease. Secondary endpoint is to estimate response rate (RR), overall survival (OS), time to treatment failure (TTF), and frequency of neurotoxity.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Phase II

Assessment
Primary outcomes	median prpgression free survival (PFS)
Key secondary outcomes	response rate (RR), overall survival (OS), time to treatment failure (TTF), and incidence of neurotoxicity

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	6 cycles of bi-weekly mFOLFOX6 plus bevacizumab regimen is followed by 6 cycles of bi-weekly sLV5FU2 plus bevacizumab regimen. Agter the 12 cycle treatment, 6 cycles of bi-weekly mFOLFOX6 plus bevacizumab regimen is re-administred. Or 4 cycles of Tri-weekly XELOX plus bevacizumab regimen is followed by 4 cycles of Trii-weekly Capacitabine plus bevacizumab regimen. After the 8 cycle treatment, 4 cycles of Tri-weekly XELOX plus bevacizumab regimen is re-administred.
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	Inclusion criteria: 1. patient of pathologically defined colorectal cancer with RECIST-based mesurable disease. 2. No prior therapy including chemotherapy, immunotherapy and radiotherapy (including radiotherapy for pain control). Patient who previously recieved 5-FU-based adjuvant therpy other than FOLFOX iis eligible if it has been completed 6 months or more before registration. 3. age 20 years old or elder 4. predictive survival period is more than 12 weeks. 5. 4 weeks or more after surgery. 6. performance status (ECOG) is 0 or 1. 7. No obvious organ failures (bone marrow, heart, lung, liver, kidiney etc.) and satisfy the following laboratory data: (1) WBC: 3,000-12,000/mm3 (2) neutrophiles: 1,500/mm3 or more (3) platelets: 100,000/mm3 or more (4) totai bilirubin: 1.5 times of institutional upper limt or less (5) AST(GOT), ALT(GPT) and ALP: 2.5 times of institutional upper limt or less (in case with metastatic liver tumor, 5 times of institutional upper limt or less) (6)serum creatinin: institutional upper limt or less (7) creatinine clearance (Cockcroft-Gault method available): 50ml/min or more (8) written informed consent with patient signature and date
Key exclusion criteria	Exclusion criteria: 1. patient treated with blood transfusion, blood products or G-CSF within 7 days before registration. 2.patient who has or clinically suspicious for brain metastasis. 3. patient with a mental disorder or a history of a CNS disorder 4. patient with paresthesia 5. patient who need drainage of peritoneal, pleural or pericardial effusion. 6. double cancer 7. hypercalcemia (albumin-modified Ca value 12mg/dl or more). 8. poorly controlled diabetes mellitus. 9. proteinuria (grade 2 or more) 10. history of severe drug hypersensitivity or drug allergy 11. poorly controlled hypertension 12. obvious abnormality in ECG
Target sample size	65

Research contact person
Name of lead principal investigator	Takashi Yoshioka
Organization	Yamagata University School of Medicine
Division name	Division of clinical oncology
Address	2-2-2 IIda Nishi, Yamagata, 990-9585 , Japan
TEL	023-628-5222
Email	ytakashi@med.id.yamagata-u.ac.jp

Public contact
Name of contact person	Chikashi Ishioka
Organization	Tohoku Clinical oncology, reserach and Education Society (T-CORE)
Division name	Administration Office
Address	4-1 Seiryo-machi, Aoba-ku, Sendai 9808575, Japan
TEL	022-717-8599
Homepage URL	http://www.t-core.jp/
Email	tcore-admin@umin.ac.jp

Sponsor
Institute	Tohoku Clinical oncology, reserach and Education Society (T-CORE)
Institute
Department

Funding Source
Organization	Tohoku Clinical oncology, reserach and Education Society (T-CORE)
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

Other administrative information
Date of disclosure of the study information	2009 Year 06 Month 05 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 05 Month 09 Day
Anticipated trial start date	2009 Year 06 Month 01 Day
Last follow-up date	2017 Year 05 Month 01 Day
Date of closure to data entry	2017 Year 10 Month 01 Day
Date trial data considered complete	2017 Year 10 Month 01 Day
Date analysis concluded	2017 Year 10 Month 01 Day

Related information
URL releasing protocol	http://www.t-core.jp
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2009 Year 06 Month 04 Day
Last modified on	2018 Year 06 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000002493