UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006433 |
|---|---|
| Receipt number | R000007635 |
| Scientific Title | A phase II study of gefitinib plus S-1 after gefitinib monotherapy in patients with adenocarcinoma of the lung |
| Date of disclosure of the study information | 2011/11/01 |
| Last modified on | 2017/10/07 14:20:51 |
* 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
A phase II study of gefitinib plus S-1 after gefitinib monotherapy in patients with adenocarcinoma of the lung
Acronym
A phase II study of gefitinib plus S-1 after gefitinib monotherapy in patients with adenocarcinoma of the lung
Scientific Title
A phase II study of gefitinib plus S-1 after gefitinib monotherapy in patients with adenocarcinoma of the lung
Scientific Title:Acronym
A phase II study of gefitinib plus S-1 after gefitinib monotherapy in patients with adenocarcinoma of the lung
Region
| Japan |
Condition
Condition
adenocarcinoma of the lung
Classification by specialty
| Pneumology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
to investigate the clinical usefulness and safety for gefitinib plus S-1 after gefitinib monotherapy in patients with adenocarcinoma of the lung
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
PFS
Key secondary outcomes
RR (gefitinib+S-1), OS, AE, and association between resistant related molecules and clinical effect
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
S-1 after gefitinib
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. adenocarcinoma of the lung was confirmed cytological or pathological examiation.
2. TR is possible for cytological or pathological examination at the entry (relapse after gefitinib monotherapy)
2. stage IV and reccurent cases after resection.
3. age 20-80 years
4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
5. tumor with negative or unkown for EGFR senstive mutation.
6. CR, PR, and SD cases after gefitinib monotherapy
Key exclusion criteria
they had a concurrent malignancy, uncontrollable complications, severe morbidity; hypersensitivity to therapeutic agents; the possibility of being pregnant, and other conditions such as hepatic inflammation, as judged by the attending physician.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Fumihiro Tanaka |
Organization
University of Occupational and Environmental Health
Division name
Second Department of Surgery
Zip code
Address
Iseigaoka, Yahatanishi-ku
TEL
0936917442
ftanaka@med.uoeh-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | koushi kuroda |
Organization
University of Occupational and Environmental Health
Division name
Second Department of Surgery
Zip code
Address
Iseigaoka, Yahatanishi-ku
TEL
0936917442
Homepage URL
kuroda-k@med.uoeh-u.ac.jp
Sponsor or person
Institute
University of Occupational and Environmental Health
Institute
Department
Personal name
Funding Source
Organization
University of Occupational and Environmental Health
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
JAPAN
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
産業医科大学病院
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 11 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2011 | Year | 09 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
| 2016 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2016 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2016 | Year | 10 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 09 | Month | 29 | Day |
Last modified on
| 2017 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007635
