UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017576 |
|---|---|
| Receipt number | 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 23:43:01 |
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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
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/
tsumi1979@gmail.com
Sponsor or person
Institute
Hokkaido Gastrointestinal Cancer Study Group (HGCSG)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020365
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