UMIN-CTR Clinical Trial

Public title

Phase II Trial of Carboplatin plus S-1 for Previously Untreated Elderly Patients with Advanced Non-small-cell lung cancer with Wild Type Epidermal Growth Factor Receptor (OLCSG1202)

Acronym

Phase II Trial of CBDCA + S-1 for 1st line Elderly NSCLC with Wild Type EGFR (OLCSG1202)

Scientific Title

Phase II Trial of Carboplatin plus S-1 for Previously Untreated Elderly Patients with Advanced Non-small-cell lung cancer with Wild Type Epidermal Growth Factor Receptor (OLCSG1202)

Scientific Title:Acronym

Phase II Trial of CBDCA + S-1 for 1st line Elderly NSCLC with Wild Type EGFR (OLCSG1202)

Region

Japan

Condition

Non-small cell lung cancer

Classification by specialty

Pneumology

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

YES

Narrative objectives1

The present study was planned with the objective of investigating the combination of carboplatin and S-1 in the treatment of previously untreated elderly patients with advanced non-small-cell lung cancer. This study is designed as a phase II study of assessment of the efficacy and tolerability.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

Response Rate

Key secondary outcomes

Progression Free Survival, Overall Survival, Quality of Life, Adverse Event, Effects of complication, Compliance with Treatment

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Four cycles of Carboplatin(AUC 5, Day 1)+ S-1 (80mg/m2/day, 2week on/2week off) followed by maintenance S-1 monotherapy in 4-week cycles until progression disease

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

70

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) Histologically or cytologically confirmed non-small-cell lung cancer with Chemo-naive patients
2) Patients who have measurable lesion or evaluable lesion by RECIST
3) Patients with Chemo-naive patients Stage three/four without any indications for radiotherapy
4) Patients aged over 70 years old
5) ECOG PS 0-2
6) Patients who have measurable lesion or evaluable lesion by RECIST
7) Adequate bone mallow function, evaluated within 14 days before enrollment (registration day is day1, and on the same day two weeks ago, is impossible) as
WBC >= 3,000/mm3
Neu >= 1,500/mm3
Plt >= 150,000/mm3
Hb >= 9 g/dL
8) Adequate liver function
T.Bil <= 1.5 mg/dL
AST/ALT <= 2.5 * upper limit of normal
9) Adequate renal function
Serum Cr <= upper limit of normal.
10) Adequate pulmonary function
PaO2 >= 60 Torr or SpO2 >= 90 % (both at rest and room air)
11) Patients who underwent palliative radiation therapy within one week were excluded
12) Patients who are able to take orally
13) Written informed consent from the patients

Key exclusion criteria

1) Patients with brain metastases with the clinical symptoms
2) Patients with disease-free interval is less than five years without treatment and even in patients with cancer or metachronous duplication of activity
3) Patients who underwent radiation therapy within one weeks (a palliative radiation therapy to the lesion, e.g. bone metastasis, was excepted from this exclusion)
4) Patients with a history of severe drug allergy
5) Pregnancy, breast feeding or wish of future bearing
6) Patients with severe complication
Interstitial pneumonia or pulmonary fibrosis detectable on Chest X-ray
History of severe heart disease (uncontrollable arrhythmia, uncontrollable angina pectoris, congestive heart failure, etc. within 3 months)
Uncontrollable diabetes mellitus
Patients with severe infection
Patients has pleural effusion, pericardial effusion and ascites to be treated
7) Patients who need to be treated by radiotherapy in an urgent
8) concomitant therapy with other pyrimidine fluoride antineoplastic agents
9) concomitant therapy with warfarin
10) concomitant therapy with dabigatran etexilate
11) Principal investigator cases that are deemed inappropriate

Target sample size

32

Name of lead principal investigator

1st name
Middle name
Last name	Katsuyuki Kiura

Organization

Okayama University Hospital

Division name

Department of Respiratory Medicine

Zip code

Address

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

TEL

086-235-7227

Email

kkiura@md.okayama-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Katsuyuki Hotta

Organization

Okayama University Hospital

Division name

Department of Respiratory Medicine

Zip code

Address

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

TEL

086-235-7227

Homepage URL

Email

khotta@md.okayama-u.ac.jp

Institute

Okayama Lung Cancer Study Group

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)

None

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

Date of disclosure of the study information

2012

Year

11

Month

16

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

http://www.lungcancerjournal.info/article/S0169-5002(17)30471-3/abstract

Number of participants that the trial has enrolled

Results

Carboplatin plus S-1 had favorable efficacy and tolerable toxicity for the elderly with NSCLC. This study met the predesigned primary endpoint, and the regimen seems to be a potent treatment option. Low TP expression in tumors might serve as a predictive maker of a better DCR. We need to conduct further studies to evaluate whether this combination is superior to the standard first-line treatment for the elderly.

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

2012

Year

07

Month

26

Day

Date of IRB

Anticipated trial start date

2012

Year

11

Month

16

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2012

Year

11

Month

16

Day

Last modified on

2017

Year

11

Month

20

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010976