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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033322
Receipt No. 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 2018/08/09

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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
Middle name
Last name Manabu Muto
Organization Graduate School of Medicine, Kyoto University
Division name Department of Therapeutic Oncology
Zip code
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
Middle name
Last name Shigeki Kataoka
Organization Graduate School of Medicine, Kyoto University
Division name Department of Therapeutic Oncology
Zip code
Address 54 Shogoin-kawahara-cho, Sakyo-ku, Kyoto
TEL 075-751-4592
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
Address
Tel
Email

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)京都市立病院(京都府)京都医療センター(京都府)三菱京都病院(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)福岡赤十字病院(福岡県)佐賀大学病院(佐賀県)熊本大学病院(熊本県)

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 Preinitiation
Date of protocol fixation
2018 Year 07 Month 25 Day
Date of IRB
Anticipated trial start date
2018 Year 08 Month 30 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
2018 Year 07 Month 08 Day
Last modified on
2018 Year 08 Month 09 Day


Link to view the page
URL(English) https://upload.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


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