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 |
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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
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
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
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
