UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026575 |
|---|---|
| Receipt number | R000030514 |
| Scientific Title | The feasibility and efficacy of neoadjuvant FOLFOXIRI followed by laparoscopic surgery for locally advaned rectal cancer: A phase II study |
| Date of disclosure of the study information | 2017/03/16 |
| Last modified on | 2018/03/16 10:29:23 |
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Basic information
Public title
The feasibility and efficacy of neoadjuvant FOLFOXIRI followed by laparoscopic surgery for locally advaned rectal cancer: A phase II study
Acronym
nacFOLFOXIRI followed by LAP(NFL)
Scientific Title
The feasibility and efficacy of neoadjuvant FOLFOXIRI followed by laparoscopic surgery for locally advaned rectal cancer: A phase II study
Scientific Title:Acronym
nacFOLFOXIRI followed by LAP(NFL)
Region
| Japan |
Condition
Condition
colorectal cancer
Classification by specialty
| Surgery in general | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate theThe feasibility and efficacy of neoadjuvant FOLFOXIRI followed by laparoscopic surgery for locally advaned rectal cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Disease control rate: DCR
Key secondary outcomes
Response Rate:RR,Progression free survival:PFS,Overall survival:OS,Time to Treatment Failure:TTF,Safety(the rate of Grade3/4toxicity)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
chemotherapy : FOLFOXIRI
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
| 74 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Histologically confirmed CRC that is not
a candidate for curative surginal resection
2)the lower edge of tumor location is Rb-P
3)diagnosed as cT2N1-3N0 or cT3/4N0-3M0
4)there is no lateral lympha node metastasis
5)Age 20-74
6)Psrformance status:0-1
7)Adequate organ functiont
8)Written informed consent prior to sutudy-specific screening procedure
Key exclusion criteria
1)Requires continuous treatment with systtematic steroids
2)History of other malignancy with a disease-free interval<1years(other than curatively treated cutaneous basal cell carcinoma,curatively treated carcinoma in situ of the cervix,and gastroenterological cancer confirmed to be cured by endoscopic mucosal resection)
3)Active infections Pr
evious palliative radiation therapy for bone metastasis or brain metastasis within 2 weeks
4)HBs antigen positive
5)Uncontrolled diarrhea,unstable angia,Uncontrolled diabetes mellitus
6)Serious complications
7)grade1 of neuropathy
8)Pregnant or lactating females,and males and fenales unwilling to use contraception
9)Psychiatric disability that would preclude study compliance
10)Otherwise determined by the investigator to be unsuitable for participation in the study
Target sample size
58
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhisa Uchiyama |
Organization
Osaka Medical College Hospital
Division name
General and Gastrointestinal Surgery
Zip code
Address
2-7 Daigaku-machi, Takatsuki City, Osaka, Japan
TEL
072-683-1211
uchi@osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tetsuji Terasawa |
Organization
Osaka Medical College Hospital
Division name
Chemotherapy Center
Zip code
Address
2-7 Daigaku-machi, Takatsuki City, Osaka, Japan
TEL
072-683-1211
Homepage URL
terasawat@osaka-med.ac.jp
Sponsor or person
Institute
Osaka Medical College Hospital
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
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
| 2017 | Year | 03 | Month | 16 | 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
Completed
Date of protocol fixation
| 2017 | Year | 03 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 03 | Month | 17 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 03 | Month | 16 | Day |
Last modified on
| 2018 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030514
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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