UMIN-CTR Clinical Trial

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

Non-small cell lung cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO

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

Primary outcomes

Progression Free Survival

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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)

Email

nhattori@hiroshima-u.ac.jp

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

Email

fujikazu@hiroshima-u.ac.jp

Institute

Hiroshima University Hospital

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）

Date of disclosure of the study information

2013

Year

09

Month

18

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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