UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012175 |
|---|---|
| Receipt number | R000014233 |
| Scientific Title | Phase II trial of Cisplatin and Irinotecan treatment as palliative-intended chemotherapy for previously untreated advanced thymic carcinoma |
| Date of disclosure of the study information | 2013/11/30 |
| Last modified on | 2019/03/22 12:31:49 |
* 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
Phase II trial of Cisplatin and Irinotecan treatment
as palliative-intended chemotherapy
for previously untreated advanced thymic carcinoma
Acronym
CDDP/CPT-11 for advanced thymic carcinoma
Scientific Title
Phase II trial of Cisplatin and Irinotecan treatment
as palliative-intended chemotherapy
for previously untreated advanced thymic carcinoma
Scientific Title:Acronym
CDDP/CPT-11 for advanced thymic carcinoma
Region
| Japan |
Condition
Condition
thymic carcinoma
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of cisplatin/irinotecan treatment for previously untreated advanced thymic carcinoma
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
response rate
Key secondary outcomes
progression-free survival, overall survival, toxicity, number of cycles
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
Cisplatin is administered intravenously on day 1 with basing on the BSA for every 4 week and Irinotecan on day 1, 8, 15 for every 4 week.
Cycles of IP treatment will be repeated every 4 weeks upto 6 cycles.
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. The patients who were definitively diagnosed with having thymic carcinoma
2. Unsuitable for curative-intent treatment
and previously untreated with chemotherapy
3. Age of 18 years or older
4. ECOG performance status 0-1
5. presence of measurable lesion with RECIST 1.1 criteria
6. With the status of four weeks from previous treatment (surgery, radiotherapy) at the time of beginning of IP chemotherapy
7. Adequate organ function
8. Life expectancy of at least 12 weeks
9. Written informed consent
Key exclusion criteria
1. With concurrent active cancer
2. Serious uncontrolled infections
3. With fever at more than 38 degree in Celicius
4. Lactating, pregnant or possibly pregnant women, or those willing to become pregnant
5.
6.
7. With malignant pleural, peritoneal effusion requiring drainage or pericardial effusion
6. With sever complication associated with operation
7. Under continuous steroid therapy
8. With uncontrolled diabetes melitus
9. With uncontrolled hypertension
10 Unstable angina or previous history of myocardial infarction within six months
11. With interstitial pneumonitis or pulmonary fibrosis detectable on chest X-ray
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Yukio |
| Middle name | |
| Last name | Hosomi |
Organization
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Division name
Department of Thoracic Oncology and Respiratory Medicine
Zip code
113-8677
Address
Honkomagome 3-18-22, Bunkyo, Tokyo
TEL
03-3823-2101
yhosomi@cick.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Okuma |
Organization
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Division name
Department of Thoracic Oncology and Respiratory Medicine
Zip code
113-8677
Address
Honkomagome 3-18-22, Bunkyo, Tokyo
TEL
03-3823-2101
Homepage URL
y-okuma@cick.jp
Sponsor or person
Institute
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Institute
Department
Personal name
Funding Source
Organization
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome 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
Ethics committee of Tokyo Metropolitan Komagome Hospital
Address
3-28-22, Honkomagome, Bunkyo, Tokyo
Tel
03-3823-2101
rinri@cick.jp
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
がん・感染症センター都立駒込病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 11 | Month | 30 | Day |
Related information
URL releasing protocol
None
Publication of results
Unpublished
Result
URL related to results and publications
None
Number of participants that the trial has enrolled
0
Results
No patient was enrolled.
Results date posted
| 2019 | Year | 03 | Month | 22 | Day |
Results Delayed
Results Delay Reason
No patient was enrolled.
Date of the first journal publication of results
Baseline Characteristics
No patient was enrolled.
Participant flow
No patient was enrolled.
Adverse events
No patient was enrolled.
Outcome measures
No patient was enrolled.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2013 | Year | 10 | Month | 31 | Day |
Date of IRB
| 2013 | Year | 10 | Month | 31 | Day |
Anticipated trial start date
| 2013 | Year | 11 | Month | 29 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 10 | Month | 30 | Day |
Last modified on
| 2019 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014233
