UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011994
Receipt number R000014019
Scientific Title A randomized phase II study of daily administrations versus alternate-day administrations of S-1 with completely resected pathological stage I (T>2cm) of non-small cell lung cancer
Date of disclosure of the study information 2013/12/01
Last modified on 2021/10/14 21:31:44

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Basic information

Public title

A randomized phase II study of daily administrations versus alternate-day administrations of S-1 with completely resected pathological stage I (T>2cm) of non-small cell lung cancer

Acronym

A randomized phase II study of daily administrations versus alternate-day administrations of S-1 with completely resected pathological stage I (T>2cm) of non-small cell lung cancer

Scientific Title

A randomized phase II study of daily administrations versus alternate-day administrations of S-1 with completely resected pathological stage I (T>2cm) of non-small cell lung cancer

Scientific Title:Acronym

A randomized phase II study of daily administrations versus alternate-day administrations of S-1 with completely resected pathological stage I (T>2cm) of non-small cell lung cancer

Region

Japan


Condition

Condition

non-small cell lung cancer

Classification by specialty

Pneumology Chest surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the feasibility and efficacy of alternate-day administrations of S-1 as adjuvant chemotherapy with completely resected p-stage I (T>2cm)

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

Feasibility

Key secondary outcomes

Safety, RFS, OS


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: S-1 alternate-day administrations; S-1
is administered orally at Monday, Wednesday, Friday and Sunday for one year.

Interventions/Control_2

B: S-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

20 years-old <=

Age-upper limit

75 years-old >=

Gender

Male and Female

Key inclusion criteria

1) Pathologically proven non-small cell lung cancer
2) Neither previous chemotherapy nor radiotherapy before operation
3) Complete resection
4) Pathological stage I (T>2cm)
5) LN dissection (ND2a)
6) Aged 20-75 years old enrollment
7) ECOG PS 0-1
8) Adequate organ function:
1. WBC >=3000/mm3
2. Neutrophil count >= 1,500 /mm3
3. Platelet count >= 100,000 /mm3
4. Hemoglobin >= 9.0 g/dL
5. total bilirubin <= 1.5 mg/dL
6. AST and ALT x 2.5 of upper limit of normal (ULN)
7. Creatinine clearance >=40mL/min
8. PaO2 >= 60mmHg or SpO2 >= 90%
9) At least lobectomy, within 8 weeks after surgery
10) Signed informed consent

Key exclusion criteria

1) Allergy against S-1
2) Severe myelosuppression, renal dysfunction or liver dysfunction
3) Usage of other fluorinated pyrimidine drugs
4) Usage of flucytosine
5) Severe drug allergy
6) Unstable angina or Myocardial Infarction within 6 months
7) Apparent interstitial pneumonitis or pulmonary fibrosis at chest rentogenogram
8) Concomitant therapy Warfarin Potassium or Dabigatran
9) Abnormality of EGG or UCG
10) Severe heart disease, serious psychiatric illness, severe infection, severe other complications
11) Uncontrolled Diabetes Mellitus
12) Ileus
13) Diarrhea
14) Uncontrolled cancer
15) HBs antigen positive
16) Other patients who are unfit for the study as determined by the attending physician.

Target sample size

90


Research contact person

Name of lead principal investigator

1st name Shinichi
Middle name
Last name Toyooka

Organization

Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences

Division name

General Thoracic Surgery and Breast and Endocrinological Surgery

Zip code

700-8558

Address

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

TEL

086-223-7151

Email

toyooka@md.okayama-u.ac.jp


Public contact

Name of contact person

1st name Hiromasa
Middle name
Last name Yamamoto

Organization

Setouchi Lung Cancer Group

Division name

Department of Thoracic Surgery, Okayama University Hospital

Zip code

700-8558

Address

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

TEL

086-223-7151

Homepage URL


Email

h.yamamoto@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 Certified Review Board

Address

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

Tel

086-235-6503

Email

ouh-crrb@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

岩国医療センター(山口県)
愛媛大学医学部附属病院(愛媛県)
岡山大学病院(岡山県)
岡山済生会総合病院(岡山県)
川崎医科大学総合医療センター(岡山県)
川崎医科大学附属病院(岡山県)
南岡山医療センター(岡山県)
京都大学医学部附属病院(京都府)
長良医療センター(岐阜県)
倉敷中央病院(岡山県)
福島県立医科大学附属病院(福島県)
中国中央病院(広島県)
鳥取大学医学部附属病院(鳥取県)
広島市立広島市民病院(広島県)
山口宇部医療センター(山口県)
関西医科大学附属病院(大阪府)


Other administrative information

Date of disclosure of the study information

2013 Year 12 Month 01 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

93

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

Main results already published

Date of protocol fixation

2013 Year 09 Month 30 Day

Date of IRB

2013 Year 11 Month 19 Day

Anticipated trial start date

2013 Year 12 Month 01 Day

Last follow-up date

2021 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 10 Month 08 Day

Last modified on

2021 Year 10 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014019


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name