UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013783 |
|---|---|
| Receipt number | R000016089 |
| Scientific Title | A phase2 trial of dose-adjusting Capecitabine plus stopped Oxaliplatin after six cycles in a XELOX regimen with Bevacizumab for untreated metastatic colorectal cancer. (GOSG C-04 trial) |
| Date of disclosure of the study information | 2014/04/23 |
| Last modified on | 2018/10/28 09:57:02 |
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Basic information
Public title
A phase2 trial of dose-adjusting Capecitabine plus stopped Oxaliplatin after six cycles in a XELOX regimen with Bevacizumab for untreated metastatic colorectal cancer. (GOSG C-04 trial)
Acronym
A phase2 trial of dose-adjusting Capecitabine plus stopped Oxaliplatin after six cycles in a XELOX regimen with Bevacizumab for untreated metastatic colorectal cancer. (GOSG C-04 trial)
Scientific Title
A phase2 trial of dose-adjusting Capecitabine plus stopped Oxaliplatin after six cycles in a XELOX regimen with Bevacizumab for untreated metastatic colorectal cancer. (GOSG C-04 trial)
Scientific Title:Acronym
A phase2 trial of dose-adjusting Capecitabine plus stopped Oxaliplatin after six cycles in a XELOX regimen with Bevacizumab for untreated metastatic colorectal cancer. (GOSG C-04 trial)
Region
| Japan |
Condition
Condition
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 dose-adjusting Capecitabine plus stopped Oxaliplatin after six cycles in a XELOX regimen with Bevacizumab as first-line chemotherapy in the patients with unresectable advanced recurrent coloreatal cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Progression Free Survival
Key secondary outcomes
Overall Survival
Overall Response Rate
Duration of response
Disease Control Rate
Duration of response during maintenance phase
Safety
Quality of Life
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
dose-adjusting Capecitabine + Oxaliplatin + Bevacizumab
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. Written informed consent.
2. Age :<=20 years
3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.
4. Histological confirmation of colorectal cancer.
5. No prior chemotherapy except adjuvant chemotherapy if completed more than 6months prior to enrollment.
6. unresectable primary tumor or with one or more unresectable metastatic tumor Measurable or evaluable disease. (RECIST 1.1)
7. survival more than 3 months.
8. Vital organ functions (listed below) are preserved within 2 weeks prior to entry.
i. Leukocyte
<=12,000/mm³,>=3,000/mm3
ii. Platelets >=100,000/mm3
iii. Hemoglobin >=9.0g/dl
iv. Total bilirubin <= 2.0ml/dl
v. AST and ALT <= 100IU/l
(200IU/l in case of liver metastasis)
vi. Serum creatinine
male <= 1.8mg/dl
female <= 1.35mg/dl
vii. INR < 1.5
viii. urinary protein <= 2+
Key exclusion criteria
1. Need to drain malignant celomic fluid.
2. Multiple primary cancers within 5 years.
3. With a history of allergic response to Fluorouracil or Levofolinate calcium or Platinium.
4. With a history of adverse events related to DPD loss.
5. Evidence of interstinal lung disease, or pulmonary fibrosis.
6. Uncontrolled infection.
7. Difficult for oral intake.
8. Radiological evidence of CNS metastases or brain cancer.
9. Complication of cerebrovascular disease or symptoms within 1 year.
10. Any surgical treatments including skin-open biopsy, trauma surgery and other more intensive surgery within 4 weeks or aspiration biopsy within one week.
11. The patient who is planning the surgical treatment during trial.
12. Administering antithrombotic drug within 10 days.
13. Need to administrate or having anti-platelets therapy (including Methotrexate aspirin and NSAIDS).
14. Evidence of bleeding diathesis or coagulopathy.
15. Uncontrollable ulcer indigestive tract.
16. Renal failure to be treated, 3+ or higher proteinuria within 2 weeks prior to entry.
17. Uncontrolled Hypertension.
18. Clinically significant (i.e. active) cardiovascular disease or past or current history (within the last 1 year) of myocardial infarction.
19. Pregnant or lactating women or women of childbearing potential.
20. Other conditions not suitable for this study.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Izumi Takeyoshi |
Organization
Gunma University Graduate School of Medicine
Division name
Department of Thoracic and Visceral Organ Surgery
Zip code
Address
3-39-22 Showa-Machi, Maebashi, Gunma, 371-8511, JAPAN
TEL
027-220-8245
takeyoshi@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroomi OGAWA |
Organization
Gunma University Graduate School of Medicine
Division name
Department of Thoracic and Visceral Organ Surgery
Zip code
Address
3-39-22 Showa-machi, Maebashi, Gunma 371-8511, JAPAN
TEL
027-220-8245
Homepage URL
hiroomio@gmail.com
Sponsor or person
Institute
Gunma Oncology Study Group
Institute
Department
Personal name
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)
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
| 2014 | Year | 04 | Month | 23 | 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
| 2013 | Year | 01 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
| 2018 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 04 | Month | 22 | Day |
Last modified on
| 2018 | Year | 10 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016089
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