UMIN-CTR Clinical Trial

Public title

A feasibility study of adjuvant chemotherapy with oral fluoropyrimidine S-1 for non-small cell lung cancer

Acronym

A feasibility study of oral adjuvant chemotherapy with S-1

Scientific Title

A feasibility study of adjuvant chemotherapy with oral fluoropyrimidine S-1 for non-small cell lung cancer

Scientific Title:Acronym

A feasibility study of oral adjuvant chemotherapy with S-1

Region

Japan

Condition

Non-small cell lung cancer

Classification by specialty

Chest surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To confrim feasibility of adjuvant chemotherapy with 1 year oral administration of S-1 for non-small cell lung cancer

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Phase II

Primary outcomes

Completion rate of scheduled adjuvant chemotherapy

Key secondary outcomes

Incidence and grade of adverse reactions.
3-year and 5-year overall survivial.
3-year and 5-year relapse free survival

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

S-1

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

Age-lower limit

20

years-old

<=

Age-upper limit

80

years-old

>

Gender

Male and Female

Key inclusion criteria

1.NSCLC with histological proof.
2.Pathological stage IB, II, or IIIA NSCLC (fifth edition of UICC/AJCC 1997) after complete resection.
3.No prior treatment except for surgery.
4.Sufficient oral intake.
5.Performance status (PS) 0 or 1.
6.Patients also had to have adequate organ function (3500 <leukocytes < 12,000/mm3; thrombocytes, >100,000/mm3; total bilirubin,<1.5 mg/dl; AST and ALT, less than twice the normal limits at each institution; BUN, <25 mg/dl; creatinine, less than the normal limits at each institution; and creatinine clearance (Ccr))

Key exclusion criteria

1.History of drug hypersensitivity.
2.Contraindication of oral S-1 administration (refer appended papaer).
3.Serious surgical or non-surgical complications
4.Active secondary cancer.
5.Watery diarrea.
6.Pregnant or lactating women.
7.Male who has intension to make pregnant
8.Patient to whom primary doctor judjed inadequate to register.

Target sample size

55

Name of lead principal investigator

1st name
Middle name
Last name	Takeshi Nagayasu

Organization

Nagasaki University Graduate School of Biomedical Sciences

Division name

Division of Surgical Oncology

Zip code

Address

1-7-1 Sakamoto Nagasaki

TEL

095-819-7304

Email

nagayasu@nagasaki-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Tomoshi Tsuchiya

Organization

Nagasaki University Graduate School of Biomedical Sciences

Division name

Division of Surgical Oncology

Zip code

Address

1-7-1 Sakamoto Nagasaki

TEL

095-819-7304

Homepage URL

Email

tomoshi@nagasaki-u.ac.jp

Institute

Division of Surgical Oncology, Department of Translational Medical Sciences, Nagasaki University Graduate School of Biomedical Sciences

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

長崎大学病院(長崎県)、佐世保総合病院(長崎県)、国立長崎医療センター(長崎県)、長崎原爆病院(長崎県)、大分県立病院(大分県)、長崎済生会病院(長崎県)、福田外科病院(長崎県)

Date of disclosure of the study information

2011

Year

10

Month

30

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

http://www.ncbi.nlm.nih.gov/pubmed/22424872

Number of participants that the trial has enrolled

Results

Results: Fifty patients were eligible. The completion rate for the planned 8 courses of S-1 administration was 72.0%
(36 patients). Total percentage administration amount was 71.1%. Grade 3 adverse reactions such as neutropenia
(4.0%), anorexia (4.0%), thrombopenia (2.0%), anemia (2.0%), elevated total bilirubin (2.0%), hypokalemia (2.0%),
nausea (2.0%), and diarrhea (2.0%) were observed, but no grade 4 adverse effects were encountered. Overall and
relapse-free survival rates at 3 years were 87.7% and 69.4%, respectively. Conclusions: Postoperative 1-year
administration of S-1 seems feasible as oral adjuvant chemotherapy for lung cancer. The oral formulation and low
incidence of adverse reactions permit treatment on an outpatient basis. The present study would be reasonable to
follow up with a properly powered phase III trial.

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

Recruitment status

Completed

Date of protocol fixation

2005

Year

06

Month

24

Day

Date of IRB

Anticipated trial start date

2005

Year

07

Month

01

Day

Last follow-up date

2012

Year

03

Month

01

Day

Date of closure to data entry

2012

Year

06

Month

01

Day

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2011

Year

10

Month

22

Day

Last modified on

2015

Year

10

Month

22

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007795