UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012098
Receipt number R000014120
Scientific Title Phase II Study of Alternate-day Administration of S-1 plus Carboplatin in Elderly Patients with Advanced Non-small Cell Lung Cancer
Date of disclosure of the study information 2013/10/22
Last modified on 2018/12/23 12:43:15

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Phase II Study of Alternate-day Administration of S-1 plus Carboplatin in Elderly Patients with Advanced Non-small Cell Lung Cancer

Acronym

Phase II Study of Alternate-day Administration of S-1 plus Carboplatin in Elderly Patients with Non-small Cell Lung Cancer

Scientific Title

Phase II Study of Alternate-day Administration of S-1 plus Carboplatin in Elderly Patients with Advanced Non-small Cell Lung Cancer

Scientific Title:Acronym

Phase II Study of Alternate-day Administration of S-1 plus Carboplatin in Elderly Patients with Non-small Cell Lung Cancer

Region

Japan


Condition

Condition

Non-small Cell Lung Cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate efficacy and safety of alternate-day administration of S-1 plus carboplatin in elderly patients with untreated advanced non-small cell lung cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

Progression-free survival

Key secondary outcomes

Response rate, safety and adverse event, 1-year survival rate, overall survival


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Induction chemotherapy with alternate-day administration of S-1 (80mg/m2/day on Mon, Wed, Fri, and Sun) plus carboplatin at the dose of area under the curve 5 (Day 1) every 3 weeks, up to 4 cycles.
Continuation maintenance chemotherapy with alternate-day administration of S-1 (80mg/m2/day on Mon, Wed, Fri, and Sun) until PD is observed.

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



Eligibility

Age-lower limit

75 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) Age of 75 years or older
2) Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
3) Incurable NSCLC with stage IIIB or stage IV (including postoperative recurrence)
4) Patients with previously untreated NSCLC. Patients who have previously undergone EGFR-TKI (Gefitinib or Erlotinib) as first line chemotherapy are considered suitable for inclusion as second line chemotherapy.
Patients are also considered suitable for inclusion, who have undergone thoracic surgery and platinum-based adjuvant chemotherapy more than 12 months earlier.
5) Performance Status (Eastern Cooperative Oncology Group: ECOG) 0-2
6) Both measurable and non-measurable lesions are acceptable as far as objective lesions are detectable by means of X-ray, CT, MRI, and RI within 28days before the entry.
7) Capable of oral intake
8) Adequate organ functions within 14 days before the entry
i) White blood cell count 3500/mm3 or over
ii) Neutrophil count 1500/mm3 or over
iii) Platelet count 100,000/m3 or over
iv) Hemoglobin 9.0g/dL or over
v) Total bilirubin 2.0mg/dL or under
vi) AST/ALT 100IU/L or under
vii) PaO2 60Torr or over, or SpO2 90% or over
viii) Creatinine clearance 50mL/min or over
9) Estimated life expectancy of at least 12 weeks
10) With written informed consent

Key exclusion criteria

1) Past history of severe drug hypersensitivity
2) Severe bone marrow suppression, renal dysfunction, or liver dysfunction
3) Treatment history of S-1, except for the cases in which S-1 had been administered as adjuvant chemotherapy and recurrence was observed more than 1 year after thoracic surgery
4) Active double cancer within 5 years of disease-free interval, except for curable lesions like carcinoma in situ and mucosal cancer
5) Severe complication such as ileus, interstitial pneumonia, uncontrolled diabetes, heart failure, renal dysfunction, liver dysfunction, active digestive ulcer, and acute myocardial infarction or angina pectoris within six months
6) Diarrhea graded 2 or more
7) Active infectious disease in need of systemic administration of antibiotics
8) Uncontrolled pleural effusion, ascites, and pericardial effusion which needs drainage
9) Uncontrolled symptomatic brain metastasis
10) Systemic administration of steroid
11) Patients with psychiatric disease or symptoms, who seem to have difficulty in participating in the study
12) Any patients judged by the investigator to be unfit to participate in the study

Target sample size

45


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name TAKEDA Takayuki

Organization

Uji-Tokushukai Medical Center

Division name

Department of Respiratory Medicine

Zip code


Address

86, Kasugamori, Ogura-cho, Uji-city, Kyoto

TEL

0774-20-1111

Email

dyckw344@yahoo.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name TAKEDA Takayuki

Organization

Uji-Tokushukai Medical Center

Division name

Department of Respiratory Medicine

Zip code


Address

86, Kasugamori, Ogura-cho, Uji-city, Kyoto

TEL

0774-20-1111

Homepage URL


Email

dyckw344@yahoo.co.jp


Sponsor or person

Institute

Tokushukai Group Oncology Project

Institute

Department

Personal name



Funding Source

Organization

Uji-Tokushukai Medical Center

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


Address


Tel


Email



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

宇治徳洲会病院、札幌東徳洲会病院、千葉徳洲会病院、湘南鎌倉総合病院、八尾徳洲会病院、大隅鹿屋病院、国保旭中央病院、名古屋徳洲会総合病院、中部徳洲会病院


Other administrative information

Date of disclosure of the study information

2013 Year 10 Month 22 Day


Related information

URL releasing protocol


Publication of results

Unpublished


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

2013 Year 10 Month 02 Day

Date of IRB


Anticipated trial start date

2013 Year 11 Month 11 Day

Last follow-up date

2016 Year 12 Month 31 Day

Date of closure to data entry

2017 Year 12 Month 31 Day

Date trial data considered complete

2017 Year 12 Month 31 Day

Date analysis concluded

2018 Year 05 Month 01 Day


Other

Other related information



Management information

Registered date

2013 Year 10 Month 22 Day

Last modified on

2018 Year 12 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014120


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name