UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011794 |
|---|---|
| Receipt number | R000011491 |
| Scientific Title | PhaseII trial of Gemcitabine(G)and Platinam-doublet plus continuous maintenance Gemcitabine in untreated stage three/four squamous non-small cell lung cancer(NSCLC) |
| Date of disclosure of the study information | 2013/09/18 |
| Last modified on | 2018/09/22 12:52:17 |
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Basic information
Public title
PhaseII trial of Gemcitabine(G)and Platinam-doublet plus continuous maintenance Gemcitabine in untreated stage three/four squamous non-small cell lung cancer(NSCLC)
Acronym
PhaseII trial of Gemcitabine(G)and Platinam-doublet plus continuous maintenance Gemcitabine in untreated stage three/four squamous non-small cell lung cancer(NSCLC)
Scientific Title
PhaseII trial of Gemcitabine(G)and Platinam-doublet plus continuous maintenance Gemcitabine in untreated stage three/four squamous non-small cell lung cancer(NSCLC)
Scientific Title:Acronym
PhaseII trial of Gemcitabine(G)and Platinam-doublet plus continuous maintenance Gemcitabine in untreated stage three/four squamous non-small cell lung cancer(NSCLC)
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 the PFS and torelability of gemcitabin/platinum-doublet continuous maintenance gemcitabine in Japanese patients with untreated stage threeB/four non-small cell lung cancer for squamous cell carcinoma
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Progression Free Survival
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
Four cycle of gemcitabine and platinum-doublet followed by maintenance gemcitabine in 21-days cycle until progression disease
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Histologically or cytologically confirmed squamous non-small cell lung cancer
2) Patients who have measurable lesion
3) Stage III/VI without any indications for radiotherapy, or recurrent disease after surgery
4) Patients aged from 20 older
5)ECOG PS 0-1
6) Adequate organ function, evaluated within 14 days before enrollment (registration day is day1, and on the same day two weeks ago, is impossible) as
WBC >= 4,000/mm3
Plt >= 100,000/mm3
Hb >= 9 g/dL
AST/ALT <=100IU/L
T.Bil <= 1.5 g/dL
Ccr >=60mL/min, sCr: x 1.2 of upper limit of normal or less.
SpO2 >= 60torr as room air
7) Patients are excepted to live over 3 months after administration day
8)Written informed consent from the patients
Key exclusion criteria
(1) Patient having clear infection
(2) Patient having hepatitis B with the activity
(3) Serious complications (stroma-related pneumonia, bleeding tendency, control are poor a heart trouble, pulmonary fibrosis)
The patient whom high blood pressure or diabetes have)
(4) Patient having an active overlap cancer (under nondisease period five years)
(5) Metastasis to brain patient having a symptom
(6) Hydrothorax to need treatment, abdominal dropsy retention patient
(7) Pericardial fluid retention patient
(8) Patient having an anamnesis of drug allergies
(9) A pregnant woman, a nursing girl and woman with the possibility (intention) of the pregnancy
(10) principal investigator cases that are deemed inappropriate
Target sample size
33
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Noboru Hattori |
Organization
Graduate School of Biomedical Sciences Hiroshima University
Division name
Department of Molecular and Internal Medicine
Zip code
Address
Kasumi 1-2-3, Minami-ku, Hiroshima
TEL
082-257-5555(5198)
nhattori@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazunori Fujitaka |
Organization
Hiroshima University Hospital
Division name
Depatment of Respiratory Medicine
Zip code
Address
Kasumi1-2-3, Minami-ku, Hiroshima
TEL
082-257-5196
Homepage URL
fujikazu@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University Hospital
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
広島市民病院（広島県）安佐市民病院（広島県）県立広島病院（広島県）広島総合病院（広島県）広島赤十字・原爆病院（広島県）三次中央病院（広島県）尾道総合病院（広島県）広島鉄道病院（広島県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 09 | Month | 18 | 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
| 2013 | Year | 03 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 03 | 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 | 09 | Month | 18 | Day |
Last modified on
| 2018 | Year | 09 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011491
