UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009845
Receipt number R000011537
Scientific Title A phase II trial of S-1 monotherapy for relapsed thymoma and thymic carcinoma: Okayama Lung Cancer Study Group Trial (OLCSG 1302)
Date of disclosure of the study information 2013/02/01
Last modified on 2013/08/23 13:57:26

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Basic information

Public title

A phase II trial of S-1 monotherapy for relapsed thymoma and thymic carcinoma: Okayama Lung Cancer Study Group Trial (OLCSG 1302)

Acronym

S-1 monotherapy for relapsed thymoma and thymic carcinoma.

Scientific Title

A phase II trial of S-1 monotherapy for relapsed thymoma and thymic carcinoma: Okayama Lung Cancer Study Group Trial (OLCSG 1302)

Scientific Title:Acronym

S-1 monotherapy for relapsed thymoma and thymic carcinoma.

Region

Japan


Condition

Condition

Thymoma/Thymic carcinoma

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and safety of S-1 monotherapy for relapsed thymoma or thymic carcinoma. Secondary endpoints are progression free survival and overall survival. And also to analyse correlation between efficacy of S-1 treatment and expression of fluoropyrimidine metabolizing enzyme such as TS, DPD, OPRT.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Progression free survival

Key secondary outcomes



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), depending on the BSA from days 1 to 14, which is followed by 7 days rest. Courses of S-1 treatment will be repeated every 3weeks until discontinuation criteria are 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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1. Histologically proven thymoma or thymic carcinoma
2. Unsuitable for curative radiotherapy or Unresectable
3. At least 1 prior chemotherapy
4. Progressive disease after the most recent chemotherapy regimen.
5. ECOG performance status 0-2
6. Age of 20 years or older
7. Presence of measurable lesions, as defined per RECIST 1.1
8. Adequate organ function
9. Life expectancy of at least 2 months
10. Written informed consent

Key exclusion criteria

1. Serious uncontrolled infections or body temperature higher than 38 degree centigrade
2. Continuous administration of an oral steroid or an immunosuppressive agent
3. With severe concurrent disease
4. Symptomatic brain metastasis
5. With malignant pleural, peritoneal effusion requiring drainage or pericardial effusion
6. With severe drug allergies
7. Contraindication with S-1
8. Previous treatment with fluoropyrimidines such as S-1, UFT
9. Current use of flucytosine
10. With interstitial pneumonitis or pulmonary fibrosis detectable on chest X-ray
11. Lactating, pregnant or possibly pregnant women, or those willing to become pregnant
12. Physician concludes that the patient's participation in this trial is inappropriate

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Katsuyuki Kiura

Organization

Okayama University Hospital

Division name

Department of Allergy and Respiratory Medicine

Zip code


Address

2-5-1, shikatacho, kitaku, okayama

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Yuka Kato

Organization

Okayama University Hospital

Division name

Department of Allergy and Respiratory Medicine

Zip code


Address


TEL

086-235-7227

Homepage URL


Email



Sponsor or person

Institute

Okayama Lung Cancer Study Group(OLCSG)

Institute

Department

Personal name



Funding Source

Organization

Okayama University 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


Address


Tel


Email



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

2013 Year 02 Month 01 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

Terminated

Date of protocol fixation

2013 Year 02 Month 01 Day

Date of IRB


Anticipated trial start date

2013 Year 02 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 01 Month 23 Day

Last modified on

2013 Year 08 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011537


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name