UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004297 |
|---|---|
| Receipt number | R000005152 |
| Scientific Title | Clinical phase II study of cisplatin plus gemcitabine followed by switch maintenance docetaxel for advanced squamous-cell lung cancer |
| Date of disclosure of the study information | 2010/09/29 |
| Last modified on | 2015/03/29 09:21:32 |
* 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
Clinical phase II study of cisplatin plus gemcitabine followed by switch maintenance docetaxel for advanced squamous-cell lung cancer
Acronym
Clinical phase II study of cisplatin plus gemcitabine followed by switch maintenance docetaxel for advanced squamous-cell lung cancer
Scientific Title
Clinical phase II study of cisplatin plus gemcitabine followed by switch maintenance docetaxel for advanced squamous-cell lung cancer
Scientific Title:Acronym
Clinical phase II study of cisplatin plus gemcitabine followed by switch maintenance docetaxel for advanced squamous-cell lung cancer
Region
| Japan |
Condition
Condition
pulmonary squamous-cellcarcinoma
Classification by specialty
| Medicine in general | Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and toxicity of the doublet chemotherapy (cisplatin and gemcitabine) and maintenance chemotherapy (docetaxel)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate primarily PFS of the doublet chemotherapy (cisplatin and gemcitabine) and maintenance chemotherapy (docetaxel)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
to evaluate the outcomes including PFS in the chemotherapy cosisting of cisplatin, gemcitabine and docetaxel
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
pathologically proven squamous cell carcinoma
stage IV or stage III without suitability for curative treatment
aged 20 or older
measurable tumor sites
no prior chemotherapy
no prior systemic anticancer therapy including palliative brain or bone irradiation within 2 weeks of proposed entry to this trial
ECOG PS of 0 to 1
appropriate organ function
acquisition of written informed
consent
Key exclusion criteria
pts with active co-morbidities including severe conditions of heart diseases, gastric ulcers, infections, uncontrollable diabetes, psychlogicai diseases, hypertension, active interstitial and hearing loss.
pts with active other cancers
pts with massive pleural and cardiac effusion and ascites that need to be immediately treated
pts with symptomatic brain metastases
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Katsuyuki Kiura |
Organization
Okayama University Hospital
Division name
Department of Respiratory Medicine
Zip code
Address
2-5-1, Shikatacho, Okayama, Japan
TEL
0862237151
khotta@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Katsuyuki Hotta |
Organization
Okayama University Hospital
Division name
Department of Respiratory Medicine
Zip code
Address
2-5-1, Shikatacho, Kitaku, Okayama
TEL
0862237171
Homepage URL
khotta@md.okayama-u.ac.jp
Sponsor or person
Institute
Okayama Lung Cancer Study Group
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
| 2010 | Year | 09 | Month | 29 | 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
Terminated
Date of protocol fixation
| 2010 | Year | 09 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 09 | Month | 01 | 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
| 2010 | Year | 09 | Month | 29 | Day |
Last modified on
| 2015 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005152
