UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002805 |
|---|---|
| Receipt number | R000003412 |
| Scientific Title | Phase II study of irinotecan in patients with chemotherapy pretreated angiosarcoma. The ANGIRI study. |
| Date of disclosure of the study information | 2010/01/10 |
| Last modified on | 2012/10/19 16:52:01 |
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Basic information
Public title
Phase II study of irinotecan in patients with chemotherapy pretreated angiosarcoma. The ANGIRI study.
Acronym
Phase II study for angiosarcoma
Scientific Title
Phase II study of irinotecan in patients with chemotherapy pretreated angiosarcoma. The ANGIRI study.
Scientific Title:Acronym
Phase II study for angiosarcoma
Region
| Japan |
Condition
Condition
Angiosarcoma
Classification by specialty
| Hematology and clinical oncology | Dermatology | Orthopedics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy of irinotecan in patients with chemotherapy-pretreated angiosarcoma
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Response rate
Key secondary outcomes
Progression free survival
overall survival
adverse event
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
Irinotecan
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. PS: 0-2
2. normal ECG
3. No ileus and no massive ascites
4. Adequate organ function
5. No prior irinotecan or topotecan treatment
Key exclusion criteria
1. Expected women
2. patients withj active infection
3. patients with interstitial pneumonia
4. patients with symptomatic brain metastasis
5. HIV positive patients
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masashi Ando |
Organization
National Cancer Center Hospital Tokyo
Division name
Breast and Medical Oncology Division
Zip code
Address
5-1-1 Tsukiji Chuuou-ku, Tokyo, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenji Hashimoto |
Organization
National Cancer Center Hospital Tokyo
Division name
Breast and Medical Oncology Division
Zip code
Address
5-1-1 Tsukiji Chuuou-ku, Tokyo, Japan
TEL
Homepage URL
Sponsor or person
Institute
Masashi Ando
Institute
Department
Personal name
Funding Source
Organization
National Cancer Center Hospital
Organization
Division
Category of Funding Organization
Other
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
| 2010 | Year | 01 | Month | 10 | 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
| 2009 | Year | 11 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 10 | Month | 19 | Day |
Date of closure to data entry
| 2012 | Year | 10 | Month | 19 | Day |
Date trial data considered complete
| 2012 | Year | 10 | Month | 19 | Day |
Date analysis concluded
| 2012 | Year | 10 | Month | 19 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 11 | Month | 27 | Day |
Last modified on
| 2012 | Year | 10 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003412
