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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000005060
Receipt No. R000006009
Scientific Title A randomized phase II study of XELOX plus Bevacizumab versus XELIRI plus Bevacizumab for advanced colorectal cancer with or without mitochondrial transcription factor A (mtTFA) expression.
Date of disclosure of the study information 2011/02/14
Last modified on 2011/02/09

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Basic information
Public title A randomized phase II study of XELOX plus Bevacizumab versus XELIRI plus Bevacizumab for advanced colorectal cancer with or without mitochondrial transcription factor A (mtTFA) expression.
Acronym FUTURE1001 study
Scientific Title A randomized phase II study of XELOX plus Bevacizumab versus XELIRI plus Bevacizumab for advanced colorectal cancer with or without mitochondrial transcription factor A (mtTFA) expression.
Scientific Title:Acronym FUTURE1001 study
Region
Japan

Condition
Condition Unresectable advanced/recurrent colorectal cancer
Classification by specialty
Medicine in general Gastroenterology Hematology and clinical oncology
Surgery in general Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Multicenter randomized phase II study of XELOX plus Bevacizumab versus XELIRI plus Bevacizumab for advanced/recurrent colorectal cancer with or without mtTFA expression.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Response rate with or without mtTFA expression
Key secondary outcomes Progression free survival with or without mtTFA expression
Overall survival with or without mtTFA expression
Safety

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 mtTFA(+):Oxaliplatin 130mg/m2 i.v. (day1)
Bevaciumab 7.5mg/Kg i.v. (day1)
Capecitabine2,000mg/m2 p.o.(day1-14)
to be repeated every 3 weeks until progression
Interventions/Control_2 mtTFA(+):Irinotecan 200mg/m2 i.v. (day1)
Bevaciumab 7.5mg/Kg i.v. (day1)
Capecitabine1,600mg/m2 p.o.(day1-14)
to be repeated every 3 weeks until progression
Interventions/Control_3 mtTFA(-):Oxaliplatin 130mg/m2 i.v. (day1)
Bevaciumab 7.5mg/Kg i.v. (day1)
Capecitabine2,000mg/m2 p.o.(day1-14)
to be repeated every 3 weeks until progression
Interventions/Control_4 mtTFA(-):Irinotecan 200mg/m2 i.v. (day1)
Bevaciumab 7.5mg/Kg i.v. (day1)
Capecitabine1,600mg/m2 p.o.(day1-14)
to be repeated every 3 weeks until progression
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
80 years-old >=
Gender Male and Female
Key inclusion criteria 1)Written informed consent.
2)Histologically confirmed adenocarcinoma of the colon or rectum.
3)unresectable or recurrent colorectal cancer.
4)No prior chemotherapy for the patients with unresectable or recurrent
colorectal cancer.
(1)Not include Neoadjuvant chemotherapy. (2)Previous adjuvant therapy is permitted if completed at least 6 months before registration.
5)No prior radiotherapy for target lesion.
6)Age >= 20 and =< 80.
7)Performance status(PS) of 0-2 in ECOG criteria.
8)With measurable lesion.
9)At least one measurable lesion based on the RECIST criterion. (within 28 days before registration)
10)Life expectancy more than 3 months.
11)Required baseline laboratory parameters (within 1 week before registration):
(1)WBC more than 2000 and WBC less than 12000/mm3.
(2)Neu more than 1,500/ mm3.
(3)Plt more than 75,000/ mm3.
(4)Hb more than 9.0g/dl.
(5)T-Bil less than 2.0mg/dl.
(6)AST,ALT 100IU/L and under.(<200 U/L in patients with liver metastasis)
(7)PT(INR) less than 1.5.
(8)Cre male:less than 1.35mg/dl, Female:less than 1.8mg/dl.
12)Urine protein controllable.
Key exclusion criteria 1)Administering transfusion/ hematopoietic factor or G-CSF and antithrombotic drug within 7 days.
2)Serious liver and renal dysfunction.
3)Serious drug hypersensitivity or a history of drug allergy.
4)Peripheral neuropathy.
5)Active double cancer.
6)Severe infectious disease.
7)High blood pressure and diabetic that cannot be controlled.
8)Symptomatic or asymptomatic but treated heart disease.
9)History of interstitial pneumonitis, pulmonary fibrosis or high-grade pulmonary emphysema.
10)History of mental disturbances or cerebrovascular accident.
11)Fresh hemorrhage from digestive tube, intestines tube paralysis, intestinal obstruction and peptic ulcer.
12)Current or previous (within one year) history of GI perforation.
13)Pleural effusion, peritoneal fluid and pericardial fluid.
14)Symptomatic brain metastasis.
15)Water solubility diarrhea.
16)Under coutinuous steroid therapy.
17)Any surgical treatments including skin-open biopsy, trauma surgery and other more intensive surgery within 4 weeks or aspiration biopsy within one week.
18)Anti-platelets therapy.(including aspirin and NSAIDS)
19)History of organ transplantation.
20)Traumatic fracture of unrecovery.
21)Bevacizumab used previous chemotherapy.
22)Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers.
23)Other conditions not suitable for this study.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoichiro Yoshida
Organization Fukuoka University School of Medicine
Division name Department of Gastroenterologial Surgery
Zip code
Address 7-45-1, Nanakuma, Johnan-ku, Fukuoka, 814-0180, Japan
TEL 092-801-1011
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yoichiro Yoshida
Organization Fukuoka University School of Medicine
Division name Department of Gastroenterologial Surgery
Zip code
Address 7-45-1, Nanakuma, Johnan-ku, Fukuoka, 814-0180, Japan
TEL 092-801-1011
Homepage URL
Email

Sponsor
Institute Fukuoka Tumor Research(FUTURE)
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 福岡大学医学部 消化器外科学

Other administrative information
Date of disclosure of the study information
2011 Year 02 Month 14 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 Open public recruiting
Date of protocol fixation
2010 Year 12 Month 15 Day
Date of IRB
Anticipated trial start date
2011 Year 02 Month 01 Day
Last follow-up date
2013 Year 10 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 02 Month 09 Day
Last modified on
2011 Year 02 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006009

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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