UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002425
Receipt number R000002970
Scientific Title A phase II trial of postoperative adjuvant chemotherapy with carboplatin/ docetaxel for the patients completely resected Non Small Cell Lung Cancer
Date of disclosure of the study information 2009/09/01
Last modified on 2014/03/01 09:22:08

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Basic information

Public title

A phase II trial of postoperative adjuvant chemotherapy with carboplatin/ docetaxel for the patients completely resected Non Small Cell Lung Cancer

Acronym

A phase II trial with carboplatin/ docetaxel in completely resected Non Small Cell Lung Cancer

Scientific Title

A phase II trial of postoperative adjuvant chemotherapy with carboplatin/ docetaxel for the patients completely resected Non Small Cell Lung Cancer

Scientific Title:Acronym

A phase II trial with carboplatin/ docetaxel in completely resected Non Small Cell Lung Cancer

Region

Japan


Condition

Condition

non-small cell lung cancer

Classification by specialty

Chest surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

feasibility

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

feasibility

Key secondary outcomes

safety, progression-free survival


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

docetaxel 60mg/m2, day1 + carboplatin AUC 5mg/mLxmin, day 1
q3w, 3 cycles

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) pathologically proven non-small cell lung cancer and possible to receive chemotherapy within 4-10 weeks after surgery
2) completely resected NSCLC and pathological stage IB, II, IIIA
3) no prior chemotherapy or radiotherapy
4) PS 0 or 1
5) age 20-80
6) written informed consent
7) adequate organ function
.WBC>=4000/mm3<=12000/mm3
.neutrophil<=2000/mm3
.platelet<=100000/mm3
.AST,ALT within 2 times of upper limit
.total bilirubin <=1.5 mg/dl
.creatinin<= 1.2 mg/dl
.creatinin clearance>=60ml/min/body
PaO2>=60Torr

Key exclusion criteria

1) active infection
2) fever
3) severe complication
4) concomittant malignant cancer
5) Uncontroled pleural effusion or ascitis
6) Pericardial effusion
7) Neuropathy
8) past history of severe allergic reaction
9) Pregnant or expecting woman
10) other conditions not suitable for this study

Target sample size

65


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takeshi Hanagiri

Organization

University
of Occupational and Environmental Health

Division name

Second Department of Surgery

Zip code


Address

1-1 Iseigaoka, Yahatanishi-ku,

TEL

093-691-7442

Email

hanagiri@med.uoeh-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hidetaka Uramoto

Organization

UOEH

Division name

Second Department of Surgery

Zip code


Address

1-1 Iseigaoka, Yahatanishi-ku,

TEL

093-691-7442

Homepage URL


Email

hidetaka@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

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


Other administrative information

Date of disclosure of the study information

2009 Year 09 Month 01 Day


Related information

URL releasing protocol


Publication of results

Partially published


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

Completed

Date of protocol fixation

2009 Year 08 Month 31 Day

Date of IRB


Anticipated trial start date

2009 Year 09 Month 01 Day

Last follow-up date

2013 Year 09 Month 01 Day

Date of closure to data entry

2013 Year 09 Month 01 Day

Date trial data considered complete

2013 Year 09 Month 01 Day

Date analysis concluded

2014 Year 12 Month 01 Day


Other

Other related information



Management information

Registered date

2009 Year 09 Month 01 Day

Last modified on

2014 Year 03 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002970


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name