UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029318 |
|---|---|
| Receipt number | R000031511 |
| Scientific Title | Safety evaluation of a short-term infusion of ramucirumab for GI tract cancer patients |
| Date of disclosure of the study information | 2017/09/28 |
| Last modified on | 2018/03/28 11:11:28 |
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Basic information
Public title
Safety evaluation of a short-term infusion of ramucirumab for GI tract cancer patients
Acronym
Safety evaluation of a short-term infusion of ramucirumab
Scientific Title
Safety evaluation of a short-term infusion of ramucirumab for GI tract cancer patients
Scientific Title:Acronym
Safety evaluation of a short-term infusion of ramucirumab
Region
| Japan |
Condition
Condition
Gastric and colorectal cancer
Classification by specialty
| Gastroenterology | Hematology and clinical oncology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety of a short-term infusion of ramucirumab
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of infusion related reaction (any grade) at the first short-term infusion
Key secondary outcomes
Incidence of infusion related reaction (any grade) at any time
Incidence of adverse events (grade3 or more) except for infusion related reaction
Duration of ramucirumab treatment
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
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
To administer ramucirumab in a short period of time
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Gastric or colorectal cancer patients who had undergone ramucirumab and are supposed to continue ramucirumab treatment
Key exclusion criteria
1. Severe respiratory or cardiovascular diseases
2. Need for dose reduction of ramucirumab
3. Past history of infusion related reaction (grade3 or more) due to chemotherapeutic agents
4. Past history of infusion related reaction (any grade) due to ramucirumab
5. Daily use of antiallergic agents or steroids due to allergic diseases
6. Inadequate conditions, as diagnoses by the primary physician
Target sample size
42
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroya Taniguchi |
Organization
Aichi Cancer Center Hospital
Division name
the Department of Clinical Oncology
Zip code
Address
1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi 464-8681, Japan
TEL
052-762-6111
h.taniguchi@aichi-cc.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Seiichiro Mitani |
Organization
Aichi Cancer Center Hospital
Division name
the Department of Clinical Oncology
Zip code
Address
1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi 464-8681, Japan
TEL
052-762-6111
Homepage URL
smitani@aichi-cc.jp
Sponsor or person
Institute
Aichi Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
Aichi Cancer Center Hospital
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
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
愛知県がんセンター中央病院(愛知県)
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 09 | Month | 28 | 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
Completed
Date of protocol fixation
| 2017 | Year | 07 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 09 | Month | 28 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 22 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 22 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 22 | Day |
Date analysis concluded
| 2018 | Year | 07 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 09 | Month | 27 | Day |
Last modified on
| 2018 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031511
