UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006967
Receipt number R000008213
Scientific Title Phase I Study of adjuvant chemotherapy for the patients resected pathological stage IA(T1>2cm) Non Small Cell Lung Cancer (SLCG0701)
Date of disclosure of the study information 2011/12/27
Last modified on 2019/05/03 21:45:58

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Basic information

Public title

Phase I Study of adjuvant chemotherapy for the patients resected pathological stage IA(T1>2cm) Non Small Cell Lung Cancer (SLCG0701)

Acronym

TS-1 for p-stage IA NSCLC(SLCG0701)

Scientific Title

Phase I Study of adjuvant chemotherapy for the patients resected pathological stage IA(T1>2cm) Non Small Cell Lung Cancer (SLCG0701)

Scientific Title:Acronym

TS-1 for p-stage IA NSCLC(SLCG0701)

Region

Japan


Condition

Condition

Non Small Cell Lung Cancer

Classification by specialty

Chest surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

to assess the efficacy and toxicity of two modified medication of S-1 adjuvant therapy for completely resected pathological stage IA (T1>2cm) non-small cell lung cancer.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

drug compliance

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Dose comparison

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

A:TS-1 day1-28, q2w for one year

Interventions/Control_2

A:TS-1 day1-14, q1w for one year

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) pathologically proven Non Small Cell Lung Cancer
2) complete resection
3) pathological stage IA (T1>2cm)
4) at least lobectomy, within 4 to 6 weaks after surgery
5) LN dissection (ND2a)
6) no prior anti cancer treatment for thoracic malignancy except for this operation
7) ECOG PS 0-1
8) adequate organ function
9) oral intake
10) Signed informed consent

Key exclusion criteria

1. sever infection, uncontrolled Diabetes Mellitus, and hypertension
2. unstable angina or Myocardial Infarction within 6 months
3. apparent interstitial pneumonitis at chest rentogenogram
4. systemic steroid therapy required
5. uncontrolled cancer
6. Pregnant or expecting woman
7. serious psychiatric illness
8. usaige of other fluorinated pyrimidine drugs
9. Concomitant therapy with flucytocine, phenytoin or Warfarin Potassium

Target sample size

80


Research contact person

Name of lead principal investigator

1st name Hiroshi
Middle name
Last name Date

Organization

Graduate School of Medicine Kyoto University

Division name

Thoracic Surgery

Zip code

606-8507

Address

54 Kawara-machi Seigoin Sakyoku, Kyoto, Kyoto 606-8507, Japan

TEL

0757513111

Email

hdate@kuhp.kyoto-u.ac.jp


Public contact

Name of contact person

1st name Shinichi
Middle name
Last name Toyooka

Organization

Setouchi Lung Cancer Group

Division name

Okayama University, Cancer and Thoracic Surgery

Zip code

700-8558

Address

2-5-1 Shikata-cho Kita-ku Okayama

TEL

086-235-7265

Homepage URL


Email

toyooka@md.okayama-u.ac.jp


Sponsor or person

Institute

Setouchi Lung Cancer Group

Institute

Department

Personal name



Funding Source

Organization

None

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

Okayama University IRB

Address

2-5-1 Shikata-cho Okayama, Okayama 700-8558, Japan

Tel

086-235-6762

Email

mae6605@adm.okayama-u.ac.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



Other administrative information

Date of disclosure of the study information

2011 Year 12 Month 27 Day


Related information

URL releasing protocol


Publication of results

Published


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

2007 Year 06 Month 01 Day

Date of IRB


Anticipated trial start date

2007 Year 06 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

2011 Year 12 Month 27 Day

Last modified on

2019 Year 05 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008213


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name