UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006310 |
|---|---|
| Receipt number | R000007461 |
| Scientific Title | Phase II study of early start of chemotherapy after excision of the primary colorectal cancer. (FUTURE 1102-Pearl star 02) |
| Date of disclosure of the study information | 2011/09/20 |
| Last modified on | 2019/05/23 16:09:02 |
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Basic information
Public title
Phase II study of early start of chemotherapy after excision of the primary colorectal cancer. (FUTURE 1102-Pearl star 02)
Acronym
Phase II study of early start of chemotherapy after excision of the primary colorectal cancer. (FUTURE 1102-Pearl star 02)
Scientific Title
Phase II study of early start of chemotherapy after excision of the primary colorectal cancer. (FUTURE 1102-Pearl star 02)
Scientific Title:Acronym
Phase II study of early start of chemotherapy after excision of the primary colorectal cancer. (FUTURE 1102-Pearl star 02)
Region
| Japan |
Condition
Condition
Colorectal Cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of the early start of chemotherapy after excision of the primary colorectal cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Efficacy
Key secondary outcomes
Response rate
Time to treatment failure
Overall survival
Progression free survival
Safety
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
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
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Histologically confirmed colorectal cancer
2.Unresectable synchronous liver metastases
3.Resection of primary colorectal cancer
4.No prior chemotherapy and radiotherapy for colorectal cancer
5.Performance Status: 0-1 (ECOG criteria)
6.Age: 20 years to 75 years
7.Vital organ functions are preserved within 7 days prior to entry
WBC :>= 3,000 and =< 12,000/mm3
Neutrophil : >=1,500/mm3
Platelet : >= 100,000/mm3
T.bil.: <= 2.0 mg/dl
AST,ALT : <=100IU/l(in case of hepatic metastatic patients are <= 200IU/l)
Creatinin : <= 1.35mg/dl(female),1.80mg/dl(male)
8.Signed written informed consent
Key exclusion criteria
1.Prior severe drug allergy
2.Cavity fluid which needs drainage
3.Presence of active infection
4.Symptomatic brain metastases
5.Multiple malignancy within 5 years disease free interval
6.Uncontrolled hypertension
7.Uncontrolled diabetes
8.Peripheral nerve disorder
9.Severe pulmonary disease
10.Significant electrocardiographic abnormality
11.Treatment with anti-platelet drug
12.Chronic systemic treatment of corticosteroid
13.Nursing or pregnant females, or females or males with female partners who are planning to pregnancy
14.Inadequate for study enrollment by the physician
Target sample size
18
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 Gastroenterological Surgery
Zip code
814-0180
Address
7-45-1,Nanakuma,Johnan-ku,Fukuoka ,814-0180,Japan
TEL
0928011011
yy4160@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Yoichiro |
| Middle name | |
| Last name | Yoshida |
Organization
Fukuoka University School of Medicine
Division name
Gastroenterological Surgery
Zip code
814-0180
Address
7-45-1,Nanakuma,Johnan-ku,Fukuoka ,814-0180,Japan
TEL
0928011011
Homepage URL
yy4160@yahoo.co.jp
Sponsor or person
Institute
Fukuoka Tumor Research(FUTURE)
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 Univesity
Address
7-45-1,Nanakuma
Tel
0928011011
yy4160@yahoo.co.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 | 09 | Month | 20 | Day |
Related information
URL releasing protocol
https://www.ncbi.nlm.nih.gov/pubmed/29863132
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/29863132
Number of participants that the trial has enrolled
18
Results
https://www.ncbi.nlm.nih.gov/pubmed/29863132
Results date posted
| 2019 | Year | 05 | Month | 23 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Same as above
Participant flow
Same as above
Adverse events
Same as above
Outcome measures
Same as above
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2011 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2011 | Year | 08 | Month | 21 | Day |
Anticipated trial start date
| 2011 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 31 | 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 | 09 | Month | 08 | Day |
Last modified on
| 2019 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007461
