UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010721 |
|---|---|
| Receipt number | R000012527 |
| Scientific Title | Assessment of efficacy and safety of continouation maintenance therapy with gemcitabine after cisplatin-gemcitabine induction chemotherapy in advanced squamous cell lung cancer (KTORG1302) |
| Date of disclosure of the study information | 2013/05/15 |
| Last modified on | 2016/11/15 17:42:51 |
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Basic information
Public title
Assessment of efficacy and safety of continouation maintenance therapy with gemcitabine after cisplatin-gemcitabine induction chemotherapy in advanced squamous cell lung cancer (KTORG1302)
Acronym
Assessment of efficacy and safety of CDDP+GEM followed by GEM in advanced squamous cell lung cancer
Scientific Title
Assessment of efficacy and safety of continouation maintenance therapy with gemcitabine after cisplatin-gemcitabine induction chemotherapy in advanced squamous cell lung cancer (KTORG1302)
Scientific Title:Acronym
Assessment of efficacy and safety of CDDP+GEM followed by GEM in advanced squamous cell lung cancer
Region
| Japan |
Condition
Condition
squamous cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and the safety of continuation maintenance therapy with gemcitabine after cisplatin-gemcitabine induction chemotherapy in advanced squamous cell lung cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Progression Free Survival
Key secondary outcomes
Overall survival
Safety
response rate
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(4 courses)
Gemcitabine(GEM):1000mg/m2, day1,8
Cisplatin(CDDP):80mg/m2, day1
contunuation meintenance chemotherapy(until PD)
Gemcitabine(GEM):1000mg/m2 day1,8
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) Patients with histologically proven squamous cell lung cancer
2) No prior chemotherapy for squamous cell lung cancer or one year after operation or adjuvant chemotherapy
3) Age 20 to 75 years
4) Performance status(ECOG) 0 or 1
5) Measurable disease according to RECIST ver 1.1
6) Sufficient organ functions
7) Life expectancy of more than 3 months
8) Written informed consent
Key exclusion criteria
1) Patients with histologically proven non-squamous cell lung cancer
2) Recognized ILD or pulmonary fibrosis on X-rays
3) Pleural effusion, peritoneal fluid and pericardial fluid that need treatment
4) Superior vena cava syndrome
5) Symptomatic brain metastasis
6) Active concomitant malignancy
7) Prior therapy with gemcitabine
8) Diabetes and hypertension that cannot be controlled
9) Liver cirrhosis
10) Symptomatic or asymptomatic but treated heart disease
11) Severe infectious disease
12) Pregnant women, possibly pregnant women, wishing to become pregnant
13) Serious drug hypersensitivity or a history of drug allergy
14) Refusal of supportive care such as blood transfusion
15) Bleeding tendency
16) Other conditions not suitable for this study
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshige Yoshioka |
Organization
Kurashiki Central Hospital (Ohara HealthCare Foundation)
Division name
Department of Respiratory Medicine
Zip code
Address
1-1-1 Miwa, Kurashiki City, Okayama, 710-8602 JAPAN
TEL
086-422-0210
hirotin@kchnet.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi Ikeda |
Organization
Kurashiki Central Hospital (Ohara HealthCare Foundation)
Division name
Department of Respiratory Medicine
Zip code
Address
1-1-1 Miwa, Kurashiki City, Okayama, 710-8602 JAPAN
TEL
086-422-0210
Homepage URL
si13546@kchnet.or.jp
Sponsor or person
Institute
Kyoto Thoracic Oncology Research Group (KTORG)
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
兵庫県立尼崎病院（兵庫県）、大津赤十字病院（滋賀県）、京都桂病院（京都府）、北野病院（大阪府）、神戸市立医療センター中央市民病院（兵庫県）、神戸市立医療センター西市民病院（兵庫県）、大阪府済生会中津病院（大阪府）、福井赤十字病院（福井県）、姫路医療センター（兵庫県）、神鋼病院（兵庫県）、京都医療センター（京都府）、彦根市立病院（滋賀県）、市立長浜病院（滋賀県）、倉敷中央病院（岡山県）、京都大学附属病院（京都府）、民医連京都中央病院（京都府）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 05 | Month | 15 | 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
Open public recruiting
Date of protocol fixation
| 2013 | Year | 04 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 05 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 05 | Month | 14 | Day |
Last modified on
| 2016 | Year | 11 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012527
