UMIN-CTR Clinical Trial

Public title

Randomized phase II study of the Induction Chemotherapy with Docetaxel alone vs CDDP+Docetaxel for c-stage IB-II Non-Small Cell Lung Cancer (JCOG 0204-MF)

Acronym

Randomized phase II study of the Induction Chemotherapy with Docetaxel alone vs CDDP+Docetaxel for c-stage IB-II Non-Small Cell Lung Cancer (JCOG 0204-MF)

Scientific Title

Randomized phase II study of the Induction Chemotherapy with Docetaxel alone vs CDDP+Docetaxel for c-stage IB-II Non-Small Cell Lung Cancer (JCOG 0204-MF)

Scientific Title:Acronym

Randomized phase II study of the Induction Chemotherapy with Docetaxel alone vs CDDP+Docetaxel for c-stage IB-II Non-Small Cell Lung Cancer (JCOG 0204-MF)

Region

Japan

Condition

pulmonary neoplasm

Classification by specialty

Chest surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate the safety and efficacy of the preoperative Docetaxel and Docetaxel-Cisplatin combination in c-stage IB/II NSCLC, and select the optimal preoperative therapy for phase III trials.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Phase II

Primary outcomes

Disease-free survival rate at 1 year

Key secondary outcomes

overall survical, disease-free survival, treatment compliance, response rate to chemotherapy, pathologic CR rate, complete resection rate, post-surgical morbidity/mortality

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

NO

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

NO

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Preoperative docetaxel-cisplatin combination chemotherapy

Interventions/Control_2

Preoperative docetaxel monotherapy

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

74

years-old

>=

Gender

Male and Female

Key inclusion criteria

(1)Newly diagnosed, pathologically documented NSCLC
(2)Clinical stage, IB (T2N0M0), IIA (T1N1M0) or IIB (T2N1M0 or T3N0M0)
(3)Age: 15-74 years old
(4)ECOG performance status 0 or 1
(5)Measurable disease
(6)Ample organ function
(7)Signed informed consent

Key exclusion criteria

(1) Invasion to the first rib or more superior chest wall
(2) Metastasis to, or involvement of, mediastinal node
(3) Active concomitant malignancy
(4)Unstable angina, recent myocardial infarction, heart failure
(5)Uncontrolled diabetes or hypertension
(6) Pregnant or lactating women
(7)Other severe complications
(8)Systemic use of corticosteroid

Target sample size

80

Name of lead principal investigator

1st name
Middle name
Last name	Harubumi Kato, M.D., Ph.D.

Organization

International University of Health and Welfare

Division name

Research Institute of Health and Welfare Sciences, Graduate School

Zip code

Address

1-3-3 Minamiaoyama, Minato-ku, Tokyo, 107-0062, JAPAN

TEL

Email

Name of contact person

1st name
Middle name
Last name	Hideo Kunitoh, M.D.

Organization

JCOG0204 Coordinating Office

Division name

Department of Respiratory Medicine, Mitsui Memorial Hospital

Zip code

Address

1 Kandaizumi-cho, Chiyoda-ku, Tokyo 101-8643, Japan

TEL

Homepage URL

http://www.jcog.jp/

Email

JCOG_sir@ml.jcog.jp

Institute

Japan Clinical Oncology Group(JCOG)

Institute

Department

Personal name

Organization

Ministry of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

YES

Study ID_1

NCT00132639

Org. issuing International ID_1

ClinicalTrials.gov by NLM

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

東北大学加齢医学研究所（宮城県）
茨城県立中央病院（茨城県）
栃木県立がんセンター（栃木県）
埼玉県立がんセンター（埼玉県）
国立がんセンター東病院（千葉県）
国立がんセンター中央病院（東京都）
杏林大学医学部（東京都）
東京医科大学（東京都）
癌研究会附属病院（東京都）
神奈川県立がんセンター（神奈川県）
横浜市立市民病院（神奈川県）
新潟県立がんセンター新潟病院（新潟県）
愛知県がんセンター（愛知県）
大阪府立成人病センター（大阪府）
大阪府立羽曳野病院（大阪府）
国立療養所近畿中央病院（大阪府）
大阪市立総合医療センター（大阪府）
兵庫県立成人病センター（兵庫県）
岡山大学医学部（岡山県）
国立病院四国がんセンター（愛媛県）
国立病院九州がんセンター（福岡県）
長崎大学医学部附属病院（長崎県）

Date of disclosure of the study information

2005

Year

07

Month

28

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

http://www.ncbi.nlm.nih.gov/pubmed/18728643

Number of participants that the trial has enrolled

Results

See the datails via "URL releasing results" above.
Also the details can be seen in the JCOG website:
http://www.jcog.jp/en/trials/index.html

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

Completed

Date of protocol fixation

2002

Year

08

Month

20

Day

Date of IRB

Anticipated trial start date

2002

Year

10

Month

01

Day

Last follow-up date

2008

Year

11

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

2009

Year

12

Month

01

Day

Other related information

Registered date

2005

Year

07

Month

28

Day

Last modified on

2014

Year

08

Month

13

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000067