UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010189 |
|---|---|
| Receipt number | R000011933 |
| Scientific Title | A phase II study of combination chemotherapy with carboplatin plus S-1 in advanced and recurrence non small cell lung cancer |
| Date of disclosure of the study information | 2013/03/07 |
| Last modified on | 2018/11/09 18:48:09 |
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Basic information
Public title
A phase II study of combination chemotherapy with carboplatin plus S-1 in advanced and recurrence non small cell lung cancer
Acronym
A phase II study of combination chemotherapy with carboplatin plus S-1 in advanced and recurrence non small cell lung cancer
Scientific Title
A phase II study of combination chemotherapy with carboplatin plus S-1 in advanced and recurrence non small cell lung cancer
Scientific Title:Acronym
A phase II study of combination chemotherapy with carboplatin plus S-1 in advanced and recurrence non small cell lung cancer
Region
| Japan |
Condition
Condition
non-small-cell lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to examine the efficacy and safety of combination chemotherapy with S-1 and carboplatin in advanced and recurence non-small lung cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Response Rate
Key secondary outcomes
Overall survival,
Progression free survival
1-year survival Rate,
Safety
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
CBDCA AUC:5 d1 q4w until PD
TS-1 was administered at fixed dose based on the body surface area(BSA) of the patient.
BSA<1.25 m2 80mg/day
BSA 1.25-1.5 m2 100mg/day
BSA>1.5 m2 120mg/day
d1-14 q4w until PD
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
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1)Histologically or cytologically confirmed non-squamuous, non-small cell lung cancer
(2)Stage III/IV non-small cell lung cancer without any indications for radiotherapy or surgery
(3)A measurable lesion according to the Response Evaluation Criteria in Solid Tumors
(4) Age:20-74years old
(5)ECOG performance status of 0 to 1
(6)With ability of oral intake
(7)Adequate organ function, evaluated within 14 days before enrollment
(8)Expected to live over 3 months after administration days.
(9)Written informed consent from the patients.
Key exclusion criteria
1)Patients with interstitial pneumonia or pulmonary fibrosis on Chest X-ray
2)Patients with pleural or pericardial effusion ,or ascites
3) Patients with active double cancer
4)Patients with significant complications
a) Uncontrolled angina pectoris, myocardial infarction, heart failure within 3 months
b)Uncontrolled diabetes or hypertension
c)Current severe infection, or suspicious of severe infection
d) Patients whose participation in the trial is judged to be inappropriate by the attending doctor. (e.g., ileus, bleeding tendency, diarrhea and varicella)
5)Patients with symptomatic brain metastasis
6)Patients with pregnancy or lactation
7) History of serious drug allergy
8) History of serious allergic reaction with CBDCA or other platinum-containing drug
9) History of serious allergic reaction with S-1
10) Being treated with other pyrimidine fluoride antineoplastic agents.
11) Being treated with flucytosine.
12) Any patients judged by the investigator to be unfit to participate in the study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | ogawara mitsumasa |
Organization
National Hospital Organization Osaka
Division name
Department of Respiratory Medicine
Zip code
Address
2-1-14 Hoenzaka, Chou-ku, Osaka 540-0006, Japan
TEL
06-6942-1331
ogawaram@onh.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | ogawara mitsumasa |
Organization
National Hospital Organization Osaka
Division name
Department of Respiratory Medicine
Zip code
Address
2-1-14 Hoenzaka, Chou-ku, Osaka 540-0006, Japan
TEL
06-6942-1331
Homepage URL
ogawaram@onh.go.jp
Sponsor or person
Institute
National Hospital Organization Osaka
Institute
Department
Personal name
Funding Source
Organization
None
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 03 | Month | 07 | 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 | 01 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 03 | Month | 07 | Day |
Last modified on
| 2018 | Year | 11 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011933
