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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017576
Receipt No. R000020365
Scientific Title Randomized pilot study of optimal dose period for indisetron tablets for preventing chemotherapy-induced nausea and vomiting with mFOLFOX6: HGCSG0703
Date of disclosure of the study information 2015/05/14
Last modified on 2015/05/14

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Basic information
Public title Randomized pilot study of optimal dose period for indisetron tablets for preventing chemotherapy-induced nausea and vomiting with mFOLFOX6: HGCSG0703
Acronym Randomized pilot study of optimal dose period for indisetron tablets for preventing chemotherapy-induced nausea and vomiting with mFOLFOX6: HGCSG0703
Scientific Title Randomized pilot study of optimal dose period for indisetron tablets for preventing chemotherapy-induced nausea and vomiting with mFOLFOX6: HGCSG0703
Scientific Title:Acronym Randomized pilot study of optimal dose period for indisetron tablets for preventing chemotherapy-induced nausea and vomiting with mFOLFOX6: HGCSG0703
Region
Japan

Condition
Condition colorectal cancer
Classification by specialty
Gastroenterology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To explore the optimal dosing period for indisetron tablets for preventing chemotherapy-induced nausea and vomiting with mFOLFOX6
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Complete protection from vomiting
Key secondary outcomes Complete protection from nausea
No use of rescue therapy
Tolerability

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 3-day indisetron regimen
Interventions/Control_2 1-day indisetron regimen
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
80 years-old >=
Gender Male and Female
Key inclusion criteria 1. patients with advanced or metastatic colorectal cancer
2. scheduled to receive full dose of mFOLFOX6 as 1st line chemotherapy, with or without targeted agents
3. age 20-80 years old
4. ECOG performance status 0-2
5. written informed consent
Key exclusion criteria 1. had any known central nervous system malignancy
2. had any seizure disorder needing anticovulsants
3. had active gastrointestinal ulcers or obstruction
4. had any other organic cause of nausea or vomiting unrelated to chemotherapy
5. were scheduled to undergo radiotherapy
6. were pregnant or nursing women
7. had any history of drug hypersensitivity
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshito Komatsu
Organization Hokkaido University Hospital
Division name Cancer Center
Zip code
Address 14-5 Kita-ku, Sapporo, Hokkaido, 060-8648, JPN
TEL 81-11-706-5657
Email ykomatsu@med.hokudai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Nakatsumi
Organization Hokkaido University Hospital
Division name Gastroenterology and Hepatology
Zip code
Address 14-5 Kita-ku, Sapporo, Hokkaido, 060-8648, JPN
TEL 81-11-706-5657
Homepage URL http://www.hgcsg.com/
Email tsumi1979@gmail.com

Sponsor
Institute Hokkaido Gastrointestinal Cancer Study Group (HGCSG)
Institute
Department

Funding Source
Organization Hokkaido Gastrointestinal Cancer Study Group (HGCSG)
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor none
Name of secondary funder(s) none

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 北海道大学病院(北海道)、苫小牧日翔病院(北海道)、苫小牧市立病院(北海道)、札幌北楡病院(北海道)、岩見沢市立総合病院(北海道)、釧路労災病院(北海道)、北見赤十字病院(北海道)、北海道消化器科病院(北海道)

Other administrative information
Date of disclosure of the study information
2015 Year 05 Month 14 Day

Related information
URL releasing protocol http://www.hgcsg.com/
Publication of results Published

Result
URL related to results and publications http://www.karger.com/Article/FullText/345920
Number of participants that the trial has enrolled
Results
Proportions of patients with complete protection from vomiting were 85.7% (95% confidence interval (CI), 63.7-97.0%) with the 3-day regimen, and 81.0% (95%CI, 58.1-94.6%) with the 1-day regimen. Proportions of patients with complete protection from nausea were 47.6% in each arm (95%CI, 25.7-70.2%). No rescue therapy rates were 66.7% (95%CI, 43.0-85.4%) vs. 57.1% (95%CI, 34.0-78.2%). No severe adverse events were observed in either arm.
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
2007 Year 12 Month 25 Day
Date of IRB
Anticipated trial start date
2008 Year 01 Month 09 Day
Last follow-up date
2009 Year 09 Month 04 Day
Date of closure to data entry
2009 Year 09 Month 04 Day
Date trial data considered complete
2009 Year 12 Month 31 Day
Date analysis concluded
2009 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2015 Year 05 Month 14 Day
Last modified on
2015 Year 05 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020365

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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