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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000013783
Receipt No. 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

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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/mm&#179;,>=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
Email 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
Email hiroomio@gmail.com

Sponsor
Institute Gunma Oncology Study 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)

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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016089

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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