UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006498 |
|---|---|
| Receipt number | R000007685 |
| Scientific Title | Palonosetoron+Aprepitant+Dexamethasone Therapy in patients receiving moderately emetogenic anticancer drugs (EJCG-1001) |
| Date of disclosure of the study information | 2011/10/07 |
| Last modified on | 2011/10/07 12:03:40 |
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Basic information
Public title
Palonosetoron+Aprepitant+Dexamethasone Therapy in patients receiving moderately emetogenic anticancer drugs (EJCG-1001)
Acronym
Palonosetoron+Aprepitant+Dexamethasone Therapy in patients receiving moderately emetogenic anticancer drugs (EJCG-1001)
Scientific Title
Palonosetoron+Aprepitant+Dexamethasone Therapy in patients receiving moderately emetogenic anticancer drugs (EJCG-1001)
Scientific Title:Acronym
Palonosetoron+Aprepitant+Dexamethasone Therapy in patients receiving moderately emetogenic anticancer drugs (EJCG-1001)
Region
| Japan |
Condition
Condition
Lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate efficacy and safety of PaIonosetron+ Aprepitant + Dexamethasone in moderately emetic CINV in lung cancer.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Complete response rate in chemotherapy of CBDCA
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
1)Aprepitant:
125mg po. 1-1.5 hr. prior to chemotherapy on Day1
80mg po. on Day 2-3.
(2)Palonosetron
0.75mg iv. prior to chemotherapy on Day1
(3)Dexamethasone: 4.95mg iv. 30 min. prior to chemotherapy on Day 1
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)No prior chemotherapy
2)Patient receiving in CBDCA and Histologically or cytologically proven Lung cancer
3)ECOG performance status of 0 to 2
4)>=Age 20
6) Ability to ingestion intake and drug administration orally
7)Written IC.
Key exclusion criteria
1)Severe complications
2)Symptomatic brain meta
4) Massive pleural or abdominal effusion
5) Intestinal paralysis or ileus
7)Hypersensitivity for PaIonosetron, Aprepitant, Dexamethasone
9) Pregnant or lactating
10) Other patients who are unfit for the study as determined by the attending physician.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshimichi Miya |
Organization
Nippom Medical School Tamanagayama Hospital
Division name
Department of Pulmonary Medicine
Zip code
Address
1-7-1, Nagayama, Tama-city, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshimichi Miya |
Organization
Nippom Medical School Tamanagayama Hospital
Division name
Department of Pulmonary Medicine
Zip code
Address
TEL
Homepage URL
tmiya@nms.ac.jp
Sponsor or person
Institute
East Japan Chesters Group (EJCG)
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 10 | Month | 07 | 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
| 2010 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 12 | Month | 01 | 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
| 2011 | Year | 10 | Month | 07 | Day |
Last modified on
| 2011 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007685
