UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005060 |
|---|---|
| Receipt number | 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 | 2023/09/01 16:52:43 |
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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 | Yoichiro |
| Middle name | |
| Last name | Yoshida |
Organization
Fukuoka University School of Medicine
Division name
Department of Gastroenterologial Surgery
Zip code
8140180
Address
7-45-1, Nanakuma, Johnan-ku, Fukuoka, 814-0180, Japan
TEL
+81928011011
yyoshida@fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoichiro |
| Middle name | |
| Last name | Yoshida |
Organization
Fukuoka University School of Medicine
Division name
Department of Gastroenterologial Surgery
Zip code
8140180
Address
7-45-1, Nanakuma, Johnan-ku, Fukuoka, 814-0180, Japan
TEL
09086695801
Homepage URL
yyoshida@fukuoka-u.ac.jp
Sponsor or person
Institute
Fukuoka University Hospital
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
Fukuoka University
Address
7-45-1Nanakuma, Jonanku
Tel
+81928011011
yyoshida@fukuoka-u.ac.jp
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
Terminated
Date of protocol fixation
| 2010 | Year | 12 | Month | 15 | Day |
Date of IRB
| 2011 | Year | 01 | Month | 15 | Day |
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
| 2023 | Year | 09 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006009
