UMIN-CTR Clinical Trial

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
Email	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
Email	skataoka@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Kyoto University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037088