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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002042
Receipt No. R000002493
Scientific Title Phase II trial of mFOLFOX6/XELOX plus bevacizumab with oxaliplatin in a stop and go fashion in advanced metastatic colorectal cancer
Date of disclosure of the study information 2009/06/05
Last modified on 2018/06/12

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Basic information
Public title Phase II trial of mFOLFOX6/XELOX plus bevacizumab with oxaliplatin in a stop and go fashion in advanced metastatic colorectal cancer
Acronym J-M-CONcePT trial phase II study(T-CORE0901)
Scientific Title Phase II trial of mFOLFOX6/XELOX plus bevacizumab with oxaliplatin in a stop and go fashion in advanced metastatic colorectal cancer
Scientific Title:Acronym 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
1st name
Middle name
Last name Takashi Yoshioka
Organization Yamagata University School of Medicine
Division name Division of clinical oncology
Zip code
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
1st name
Middle name
Last name Chikashi Ishioka
Organization Tohoku Clinical oncology, reserach and Education Society (T-CORE)
Division name Administration Office
Zip code
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)

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
2009 Year 06 Month 05 Day

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

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 Completed
Date of protocol fixation
2009 Year 05 Month 09 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000002493

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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