UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002042 |
|---|---|
| Receipt number | 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 12:20:35 |
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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
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/
tcore-admin@umin.ac.jp
Sponsor or person
Institute
Tohoku Clinical oncology, reserach and Education Society (T-CORE)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002493
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