UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010736
Receipt number R000012528
Scientific Title Phase II trial of S-1 treatment as palliative-intent chemotherapy for previously treated advanced thymic carcinoma
Date of disclosure of the study information 2013/05/16
Last modified on 2021/04/02 17:20:49

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Basic information

Public title

Phase II trial of S-1 treatment
as palliative-intent chemotherapy
for previously treated advanced thymic carcinoma

Acronym

S-1 for thymic carcinoma

Scientific Title

Phase II trial of S-1 treatment
as palliative-intent chemotherapy
for previously treated advanced thymic carcinoma

Scientific Title:Acronym

S-1 for 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 S-1 treatment for previous treated 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

S-1 treatment: S-1 is administered orally twice daily after morning and evening meals at a dose of 40-60 mg (80-120 mg/day) with basing on the BSA for 2 weeks-on, which is followed by 1 week-off. Cycles of S-1 treatment will be repeated every 3 weeks until discontinuation criteria is met.

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 treated with at least 1 prior cisplatin-based chemotherapy
3. Age of 18 years or older
4. ECOG performance status 0-2
5. presence of measurable lesion with RECIST 1.1 criteria
6. With the status of previous treatment (surgery, radiotherapy, or chemotherapy) at the time of beginning of S-1 chemotherapy
7. Adequate organ function
8. Life expectancy of at least 12 weeks
9. Written informed consent

Key exclusion criteria

1. With severe drug allergies for tegafur
2. With severe myleosuppression, renal disturbance, or liver disturbance
3. Current use of flucytosine
4. With severe uncontrolled systemic complication
5. Serious uncontrolled infections
6. With concrrent other malignant tumro
7. With malignant pleural, peritoneal effusion requiring drainage or pericardial effusion
8. With continuous diarrhea
9. With bowel paralysis or obstruction
10. With interstitial pneumonitis or pulmonary fibrosis detectable on chest X-ray
11.Symptomatic or uncontrolled brain metastasis
12. The patients treated with unapproved drugs within 30 days
13. Lactating, pregnant or possibly pregnant women, or those willing to become pregnant
14. Unable to intake orally

Target sample size

26


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

Honkomagome 3-18-22, 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

公益財団法人がん研究会有明病院(東京都)
がん・感染症センター都立駒込病院(東京都)
国立がん研究センター中央病院(東京都)


Other administrative information

Date of disclosure of the study information

2013 Year 05 Month 16 Day


Related information

URL releasing protocol

https://onlinelibrary.wiley.com/doi/10.1002/cam4.3385

Publication of results

Published


Result

URL related to results and publications

https://onlinelibrary.wiley.com/doi/10.1002/cam4.3385

Number of participants that the trial has enrolled

26

Results

One patient showed complete response and seven patients showed partial responses, resulting in a 30.8% response rate (90% confidence interval [CI], 18.3-46.9) and an 80.8% disease control rate (90% CI, 65.4-90.3) in 25 pts. The median PFS was 4.3 months (95% CI, 2.3-10.3 months) and median OS was 27.4 months (95% CI, 16.6-34.3). Adverse events of greater than 3 included neutropenia (12%), skin rash (8%), elevated alanine aminotransferase, and fatigue (4%). No treatment related death was observed.

Results date posted

2021 Year 04 Month 02 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2020 Year 08 Month 19 Day

Baseline Characteristics

Registered.

Participant flow

Registered.

Adverse events

Registered.

Outcome measures

Registered.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Main results already published

Date of protocol fixation

2013 Year 04 Month 01 Day

Date of IRB

2013 Year 05 Month 01 Day

Anticipated trial start date

2013 Year 05 Month 01 Day

Last follow-up date

2018 Year 03 Month 31 Day

Date of closure to data entry

2018 Year 03 Month 31 Day

Date trial data considered complete

2018 Year 03 Month 31 Day

Date analysis concluded

2018 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2013 Year 05 Month 16 Day

Last modified on

2021 Year 04 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012528


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name