UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008202 |
|---|---|
| Receipt number | R000009669 |
| Scientific Title | Phase II study of weekly Vinorelbine and Topotecan administration treatment for refractory adult rhabdomyosarcoma previously treated by VAC regimen |
| Date of disclosure of the study information | 2012/06/20 |
| Last modified on | 2012/06/19 08:36:42 |
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Basic information
Public title
Phase II study of weekly Vinorelbine and Topotecan administration treatment for refractory adult rhabdomyosarcoma previously treated by VAC regimen
Acronym
V-TOP trial
Scientific Title
Phase II study of weekly Vinorelbine and Topotecan administration treatment for refractory adult rhabdomyosarcoma previously treated by VAC regimen
Scientific Title:Acronym
V-TOP trial
Region
| Japan |
Condition
Condition
Adult rhabdomyosarcoma with prior VAC therapy
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and safety of the combination with vinorelbine and topotecan for adult rabdomyosarcoma with prior VAC therapy
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Response rate
Key secondary outcomes
Progression-free survival
Overall survival
Adverse events
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
Vinorelvine 20 mg/m-2 day 1, 8
Topotecan 4 mg/m-2 day 1, 8
q 3 weeks until disease progression or intorelable toxicities
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
a) age >= 20 years old
b) PS 0 to 2
c) no annormal findings on ECG
d) no massive ascitis and ileus
e) appropriate organ finctions
(1) WBC 3,000/mm-3 <= or ANC <= 1,000/mm-3, Platlet >= 100,000/mm-3
(2) AST and ALT < 5 times x upper normal limit
(3) Total birilubin < 1.5 mg/dL
(4) serum creatinine < 1.5 mg/dL
f) no prior treatment wih vinorelbine, topotecan and irinotecan
g) more than one weeks after the completion of prior treatment (radiotherapy, surgery, or chemotherapy)
h) written informed consent
Key exclusion criteria
a) pregancy
b) sereve infection
c) interstitual pneumonia or lung fibrosis
d) symptomatic CNS metastases
e) HIV infection
f) nuerotoxicity with >= grade 3
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makoto Kodaira |
Organization
National Cancer Center Hospital
Division name
Division of breast and medical oncology
Zip code
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
TEL
03-3542-2511
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makoto Kodaira |
Organization
National Cancer Center Hospital
Division name
Division of breast and medical oncology
Zip code
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
TEL
03-3542-2511
Homepage URL
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
National Cancer Center Hospital
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
| 2012 | Year | 06 | Month | 20 | 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
| 2011 | Year | 05 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 06 | Month | 19 | Day |
Last modified on
| 2012 | Year | 06 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009669
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
