UMIN-CTR Clinical Trial

Public title

Randomized phase II trial of daily administrations versus alternate-day administrations of S-1 in patients with advanced non-small cell lung cancer

Acronym

NJLCG1102

Scientific Title

Randomized phase II trial of daily administrations versus alternate-day administrations of S-1 in patients with advanced non-small cell lung cancer

Scientific Title:Acronym

NJLCG1102

Region

Japan

Condition

Non-small cell Lung Cancer

Classification by specialty

Pneumology	Hematology and clinical oncology	Chest surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate the efficacy and safety of daily administrations versus alternate-day administrations of S-1 in patients with non-small cell lung cancer

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Phase II

Primary outcomes

Safety
(Incidence of grade3 or higher Adverse Events)

Key secondary outcomes

Response Rate
Progression-free Survival
Overall Survival
Completion rate of 1st course

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Daily administrations:
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 28, which is followed by 14 days rest.

Interventions/Control_2

Alternate-day administrations:
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 on Mondays, Wednesdays, Fridays and Sundays

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

Not applicable

Gender

Male and Female

Key inclusion criteria

1)Histologically or cytologically confirmed NSCLC
2)Unresectable or reccurent NSCLC
3)With or without measurable lesions
4)With at least 1 prior chemotherapy
5)Age of 20 years or older
6)ECOG performance status 2 or less
7)With adequate major organ functions within 14 days before randomization, as defined below:
*White blood cell count >= 3,000/mm3
*Neutrophil count >= 1,500/mm3
*Platelet count >= 100,000/mm3
*Hemoglobin >= 9.0 g/dL
*AST <= 2.5 x ULN
*ALT <= 2.5 x ULN
*Total bilirubin <= 1.5 mg/dL
*PaO2 >= 60 Torr or SpO2 >= 94%
*Estimated CCr >= 50 mL/min.
8)Sufficient oral intake
9)Written informed consent

Key exclusion criteria

1)With interstitial pneumonitis or pulmonary fibrosis detectable on chest X-ray
2)Contraindication with S-1
3)With double cancer, multiple cancer
4)With malignant pleural, peritoneal effusion requiring drainage or pericardial effusion
5)With concurrent disease
6)With symptomatic brain metastasis
7)With severe diarrhea
8)Previous treatment with fluoropyrimidines such as S-1, UFT, 5-FU
9) Current use of flucytosine
10)Lactating, pregnant or possibly pregnant women, or those willing to become pregnant
11)Physician concludes that the patient's participation in this trial is inappropriate

Target sample size

60

Name of lead principal investigator

1st name
Middle name
Last name	Makoto Maemondo

Organization

Miyagi Cancer Center

Division name

Dept. of Respiratory Medicine

Zip code

Address

47-1 Nodayama, Medesima-shiote, Natori, Miyagi, 981-1293, Japan

TEL

81-22-384-3151

Email

maemondo-ma693@miyagi-pho.jp

Name of contact person

1st name
Middle name
Last name	Makoto Maemondo

Organization

Miyagi Cancer Center

Division name

Dept. of Respiratory Medicine

Zip code

Address

47-1 Nodayama, Medesima-shiote, Natori, Miyagi, 981-1293, Japan

TEL

81-22-384-3151

Homepage URL

Email

maemondo-ma693@miyagi-pho.jp

Institute

North Japan Lung Cancer Study Group

Institute

Department

Personal name

Organization

North Japan Lung Cancer Study Group

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

YES

Study ID_1

NJLCG1102

Org. issuing International ID_1

North Japan Lung Cancer Study Group

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2011

Year

12

Month

28

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Main results already published

Date of protocol fixation

2011

Year

12

Month

24

Day

Date of IRB

Anticipated trial start date

2012

Year

01

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2011

Year

12

Month

28

Day

Last modified on

2016

Year

08

Month

13

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008215