UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024643
Receipt number R000028349
Scientific Title A phase II study of S-1 plus cisplatin with concurrent radiation for locally advanced thymic carcinoma (LOGIK1605/JART-1501)
Date of disclosure of the study information 2016/10/31
Last modified on 2021/03/30 15:18:31

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Basic information

Public title

A phase II study of S-1 plus cisplatin with concurrent radiation for locally advanced thymic carcinoma (LOGIK1605/JART-1501)

Acronym

A phase II study of S-1 plus cisplatin with concurrent radiation for locally advanced thymic carcinoma (LOGIK1605/JART-1501)

Scientific Title

A phase II study of S-1 plus cisplatin with concurrent radiation for locally advanced thymic carcinoma (LOGIK1605/JART-1501)

Scientific Title:Acronym

A phase II study of S-1 plus cisplatin with concurrent radiation for locally advanced thymic carcinoma (LOGIK1605/JART-1501)

Region

Japan


Condition

Condition

Thymic carcinoma

Classification by specialty

Medicine in general Pneumology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

We investigate the efficacy and the safety of S-1 plus cisplatin with concurrent radiation in patients with locally advanced thymic carcinoma.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

response rate

Key secondary outcomes

Overall survival (OS)
Progression free survival (PFS) Adverse event (AE)


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

1) S-1 is orally administered twice a day at day 1-14 and day 29-42.
Dose of S-1: 80mg/m2/day, 40mg/m2/dose x 2 times
2) Cisplatin 60 mg/m2/day at day 1 and day29.
3) Daily radiation at 2.0 Gy/time from day 1 for 5times /weeks, total 30 times. Total radiation 60Gy.
If the apparent effect of tumor reduction is observed by protocol treatment and a surgical resection is ethically required, surgical resection is applicable.

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

75 years-old >=

Gender

Male and Female

Key inclusion criteria

1.Patients with thymic carcinoma confirmed histologically.
2.Patients without treatment history of chemotherapy, radiation and surgical resection for thymic carcinoma.
3.Patients with unresectable locally advanced cancer and with Masaoka stage classification, stage III.
Eligible for only metastasis to supraclavicular fossa or mediastinal lymph node with Masaoka stage classification, stage IVb.
4.Patients who is judged that radical irradiation is possible by a treatment plan of radiotherapist.
5.Patients without active double cancer.
6.Patient is at least 20 years of age (at enrollment date).
7.Performance status (ECOG): 0-1
8.The latest clinical laboratory test within 14 days prior to enrollment (it is eligible on the same day 2 weeks before the enrolment day) meets the following all standard.
1)WBC >= 3000/mm3 or neutrophil count >=1,500/mm3
2)Hemoglobin >= 9.0g/dL
3)Platelet count>= 100,000/mm3
4)AST, ALT < 100 IU/L
5)Total bilirubin <= 1.5mg/dL
6)Creatinine clearance >= 60 mL/min (Cockcroft-Gault method, 24 hrs method)
7)PaO2 >= 60 Torr or SpO2 >= 90%
9.Patients providing the written informed consent.
10.Patients with life expectancy of at least 3 months.

Key exclusion criteria

1. Patients who requires urgent radiation therapy with a symptom of superior vena cava syndrome.
2. Patients with serious complications : such as uncontrollable angina pectoris, myocardial infarction within 3 months and heart failure, uncontrollable diabetes mellitus,hypertension and serious infection.
3. Patients with interstitial pneumonia confirmed by chest X-ray.
4. Patients having complications judged to affect the enforcement of treatment.
5. Patients with anamnesis of severe hypersensitivity.
6. Patients with pregnant or possibly pregnant.Patients with nursing.
7. Patients who are different for the participation in the study by complication of mental disease or psychiatric symptom.
8. Any other patients who are regarded as unsuitable for this study by the investigators.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Minoru Fukuda

Organization

Nagasaki University Hospital

Division name

Clinical Oncology Center

Zip code


Address

1-7-1 Sakamoto, Nagasaki 852-8501, Japan

TEL

095-819-7779

Email

mifukuda258@nifty.com


Public contact

Name of contact person

1st name
Middle name
Last name (1)Minoru Fukuda (2) Takuya Yamazaki

Organization

Nagasaki University Hospital

Division name

(1)Clinical Oncology Center (2) Department of Radiological Sciences

Zip code


Address

1-7-1 Sakamoto, Nagasaki 852-8501, Japan

TEL

095-819-7779

Homepage URL


Email

mifukuda258@nifty.com


Sponsor or person

Institute

Clinical Research Support Center Kyushu

Institute

Department

Personal name



Funding Source

Organization

Clinical Research Support Center Kyushu

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor

1) Lung Oncology Group in Kyushu (LOGIK)
2) Japanese Association for Research on the Thymus (JART)

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

長崎大学(長崎県)
飯塚病院(福岡県)
九州大学(福岡県)国立病院機構大牟田病院(福岡県)
国立病院機構九州がんセンター (福岡県)国立病院機構福岡東医療センター(福岡県)
福岡大学 (福岡県)
佐賀大学 (佐賀県)
熊本大学(熊本県)
熊本地域医療センター(熊本県)
熊本中央病院(熊本県)
宮崎県立宮崎病院(宮崎県)
鹿児島市立病院(宮崎県)
鹿児島大学(鹿児島県)
国立病院機構沖縄病院(沖縄県)
下関市立市民病院(山口県)
沖縄県立南部医療センター・こども医療センター(沖縄県)
国立病院機構岩国医療センター(山口県)
国立病院機構近畿中央胸部疾患センター(大阪府)
大分大学(大分県)
大阪大学大学院医学系研究科(大阪府)
京都府立医科大学(京都府)


Other administrative information

Date of disclosure of the study information

2016 Year 10 Month 31 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

Completed

Date of protocol fixation

2016 Year 09 Month 26 Day

Date of IRB

2016 Year 11 Month 29 Day

Anticipated trial start date

2017 Year 01 Month 31 Day

Last follow-up date

2020 Year 10 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 10 Month 31 Day

Last modified on

2021 Year 03 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028349


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name