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

Email

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


Email

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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014233


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name