UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007932 |
|---|---|
| Receipt number | R000009340 |
| Scientific Title | Quality of life study of palonosetron and dexamethasone in chemonaive patinets with advanced colorectal cancer treated with moderateemetic chemotherapy |
| Date of disclosure of the study information | 2012/05/11 |
| Last modified on | 2016/11/14 21:20:12 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Quality of life study of palonosetron and dexamethasone in chemonaive patinets with advanced colorectal cancer treated with moderateemetic chemotherapy
Acronym
Palonosetoron and dexamethasone QOL study
Scientific Title
Quality of life study of palonosetron and dexamethasone in chemonaive patinets with advanced colorectal cancer treated with moderateemetic chemotherapy
Scientific Title:Acronym
Palonosetoron and dexamethasone QOL study
Region
| Japan |
Condition
Condition
advanced colorectal cancer recieving moterate emetic chemotherapy
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of palonosetoron and dexamethasone in patients recieving moderate emetic chemotherapy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
MAT(MASCC Antiemesis Tool)
QOL-ACD(The QOL Questionnaire for Cancer Patients Treated with Anticancer Drugs)
Key secondary outcomes
safety
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
palonosetoron and dexamethasone
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Age; more than 20 years-old
2. Histologicaly proven colorectal cancer
3. Chemotherapy naive
4. Patients recieving moderate emetic chemorerapy including oxaliplatin or irinotecan
5. Adequate organ function as follows: WBC > 3000/mm3, AST < 100IU/L, ALT < 100IU/L
6. Perfomance Status(ECOG): 0-2
7. Written informed consent
Key exclusion criteria
1. Uncontrolled severe complication disease, such as ileus, idiopatic pulmomary fibrosis, daibetes, cardiac infarction, angina pectoris, renal failure, hepatic failure, mental disorder, cerebral vansular disease, active gastrointestinal tract ulcer.
2. Symptomatic brain metastasis
3. Epilepsy patint treated with antiepileptic agent, exclusing being stable clinically
4. Patient with massive pleural effusion or ascitis to be required dranage
5. Obstruction of the gastric outlet or ileus
6.Grade 2 or more nausea and vomiting
7.Anaphylaxis to palonosetron or dexamethasone
8. Patients treated with 5-HT3 antagonist, NK1 antagonist, SSRI, SNRI
9.Patient not to use birth contorol
10. Unsuitable patients by investigator
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koji Takeda |
Organization
Osaka City General Hospital
Division name
Department of Clinical Oncology
Zip code
Address
2-13-22, Miyakojimahondohri, Miyakojima-ku, Osaka, Japan
TEL
06-6929-1221
kkk-take@ga2.so-net.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koji Takeda |
Organization
Osaka City General Hospital
Division name
Department of Clinical Oncology
Zip code
Address
2-13-22, Miyakojimahondohri, Miyakojima-ku, Osaka, Japan
TEL
06-6929-1221
Homepage URL
kkk-take@ga2.so-net.ne.jp
Sponsor or person
Institute
Osaka City General Hospital
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
大阪市立総合医療センター
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 05 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2012 | Year | 03 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2015 | Year | 01 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 05 | Month | 11 | Day |
Last modified on
| 2016 | Year | 11 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009340
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
