UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012098
Receipt No. 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

* 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
Institute Tokushukai Group Oncology Project
Institute
Department

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
URL(English) https://upload.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


Contact us.