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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000005132
Receipt No. R000006103
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 2011/04/01
Last modified on 2011/08/24

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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 refractory adult rhabdomyosarcoma previously treated by VAC regimen.
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To identify the efficacy of vinorelbine and topotecan in adult rhabdomyosarcoma
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase I,II

Assessment
Primary outcomes Response rate
Key secondary outcomes Adverse event
Progression-free survival
Overall survival

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 Topotecan, Vinorelbine
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. Age => 20
2. PS 0-2
3. ECG clinically not significant
4. No clinical signs of ileus, huge ascites
5. Normal bone marrow functions
6. Normal organ function by blood test
7. NO previous treatment of irinotecan, topotecan, and vinorelbine
8. Informed consent available
Key exclusion criteria 1. No pregnant
2. No active infections
3. No interstitial pneumonia by X-ray
4. No symptom of brain metastais
5. No HIV positive
6. No grade 3 peripherasl neuropathy
Target sample size 16

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masashi Ando
Organization National Cancer Research Center Hospital
Division name Breast and Medical Oncology Division
Zip code
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL 03-3542-2511
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kenji Hashimoto
Organization National Cancer Research Center Hospital
Division name Breast and Medical Oncology Division
Zip code
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL 03-3542-2511
Homepage URL
Email kehashim@ncc.go.jp

Sponsor
Institute National Cancer Research Center Hospital
Institute
Department

Funding Source
Organization National Cancer Research Center
Organization
Division
Category of Funding Organization
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
Email

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 独立行政法人 国立がん研究センター 中央病院

Other administrative information
Date of disclosure of the study information
2011 Year 04 Month 01 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 Enrolling by invitation
Date of protocol fixation
2011 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 06 Month 01 Day
Last follow-up date
2016 Year 03 Month 01 Day
Date of closure to data entry
2017 Year 03 Month 01 Day
Date trial data considered complete
2017 Year 03 Month 01 Day
Date analysis concluded
2017 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2011 Year 02 Month 24 Day
Last modified on
2011 Year 08 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006103

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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