UMIN-CTR Clinical Trial

Recruitment status Terminated
Unique ID issued by UMIN UMIN000012175
Receipt No. 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 (Ver. 10)

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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
Last 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
Email yhosomi@cick.jp

Public contact
1st 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
Email y-okuma@cick.jp

Sponsor
Institute Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014233