UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000006310
Receipt No. 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 (Ver. 4)

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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
Last 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
Email yy4160@yahoo.co.jp

Public contact
1st 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
Email yy4160@yahoo.co.jp

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 Fukuoka Univesity
Address 7-45-1,Nanakuma
Tel 0928011011
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007461