UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033322 |
|---|---|
| Receipt number | R000037088 |
| Scientific Title | The multicenter clinical trial to investigate the safety and efficacy of FOLFOX therapy in gastrointestinal cancer patients undergoing hemodialysis |
| Date of disclosure of the study information | 2018/08/01 |
| Last modified on | 2021/01/11 11:54:50 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The multicenter clinical trial to investigate the safety and efficacy of FOLFOX therapy in gastrointestinal cancer patients undergoing hemodialysis
Acronym
The feasibility study of FOLFOX therapy in gastrointestinal cancer patients undergoing hemodialysis
Scientific Title
The multicenter clinical trial to investigate the safety and efficacy of FOLFOX therapy in gastrointestinal cancer patients undergoing hemodialysis
Scientific Title:Acronym
The feasibility study of FOLFOX therapy in gastrointestinal cancer patients undergoing hemodialysis
Region
| Japan |
Condition
Condition
gastrointestinal cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
[Part1]
To clarify the DLT of mFOLFOX7 therapy in gastrointestinal cancer patients undergoing hemodialysis, and to determine the recommended starting dose(RD) for the part2.
[Part2]
To evaluate the efficacy and safety of mFOLFOX7 therapy when treated at the RD determined in the part1.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
[Part1]
Rate of DLT
[Part2]
Rate of completing the protocol therapy
Key secondary outcomes
[Part1]
Adverse event
[Part2]
Adverse event, 1-year survival rate, PFS, response rate
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
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Four cycles of modified FOLFOX7 therapy every 2 weeks.
Treatment is started on the non-dialysis day, and dialysis continues even during continuous administration of 5-FU.
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
| Not applicable |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patients undergoing hemodialysis
2) Patients diagnosed as colorectal cancer. (It does not matter whether or not measurable lesion is present.)
3) 75 to 80 years old, and PS is 0-1. Or less than 75years old, and PS is 0-2.
4) Organ functions other than renal function are maintained.
5) Chemotherapy naive case. Postoperative adjuvant chemotherapy cases also qualify.
6) The written consent can be obtained.
Key exclusion criteria
1) Hyperammonemia within 14 days before registration.
2) Peripheral sensory neuropathy Grade 2 (evaluated in CTCAE v 4.0) or more.
3) Oral administration of warfarin is necessary.
4) During peritoneal dialysis.
5) Cirrhosis (Child-Pugh B, C)
6) Symptoms that suspect encephalopathy such as gait disturbance and language disorder.
7) Patients refused to participate in this study.
8) The doctor judged inappropriate to register for this study
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Manabu |
| Middle name | |
| Last name | Muto |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Therapeutic Oncology
Zip code
606-8507
Address
54 Shogoin-kawahara-cho, Sakyo-ku, Kyoto
TEL
075-751-3518
mmuto@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Shigeki |
| Middle name | |
| Last name | Kataoka |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Therapeutic Oncology
Zip code
606-8507
Address
54 Shogoin-kawahara-cho, Sakyo-ku, Kyoto
TEL
075-751-4392
Homepage URL
skataoka@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science(KAKENHI)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
KyotoUniversity Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN
Tel
075-753-4680
ethcom@kuhp.kyoto-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
市立札幌病院（北海道）筑波大学（茨城県）虎ノ門病院（東京都）聖マリアンナ医科大学（神奈川県）静岡県立総合病院（静岡県）滋賀県立総合病院（滋賀県）大津赤十字病院（滋賀県）京都大学医学部附属病院（京都府）京都市立病院（京都府）北野病院（大阪府）大阪赤十字病院（大阪府）枚方公済病院（大阪府）神戸市立医療センター中央市民病院（兵庫県）九州大学病院（福岡県）佐賀大学医学部附属病院（佐賀県）宮崎大学医学部附属病院（宮崎県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 08 | Month | 01 | 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
| 2018 | Year | 07 | Month | 25 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 11 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 30 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 07 | Month | 08 | Day |
Last modified on
| 2021 | Year | 01 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037088
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
