UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009914
Receipt number R000011616
Scientific Title A randomized phase II study of Cisplatin plus S-1 versus Cisplatin plus Pemetrexed, with thoracic radiotherapy for locally advanced non-squamous non-small cell lung cancer
Date of disclosure of the study information 2013/01/31
Last modified on 2020/12/01 14:18:09

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Basic information

Public title

A randomized phase II study of Cisplatin plus S-1 versus Cisplatin plus Pemetrexed, with thoracic radiotherapy for locally advanced non-squamous non-small cell lung cancer

Acronym

Randomized phase II study of CDDP+S-1+TRT vs. CDDP+PEM+TRT for locally advanced non-sq NSCLC.

Scientific Title

A randomized phase II study of Cisplatin plus S-1 versus Cisplatin plus Pemetrexed, with thoracic radiotherapy for locally advanced non-squamous non-small cell lung cancer

Scientific Title:Acronym

Randomized phase II study of CDDP+S-1+TRT vs. CDDP+PEM+TRT for locally advanced non-sq NSCLC.

Region

Japan


Condition

Condition

Non-squmous non-small cell lung cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate safety and efficacy of CDDP+S-1P+TRT and CDDP+PEM+TRT in patients with locally advanced non-squamous non-small cell lung cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

2-year progression-free survival rate

Key secondary outcomes

Rate of treatment completion, rate of adverse events, response rate, overall survival


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

YES

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Combination chemotherapy of S-1 plus cisplatin and concurrent thoracic radiotherapy

Interventions/Control_2

Combination chemotherapy of pemetrexed plus cisplatin and concurrent thoracic radiotherapy

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

74 years-old >=

Gender

Male and Female

Key inclusion criteria

(1) Pathologically proven non-squamous non-small cell lung cancer
(2) Clinical stage IIIA or IIIB based on the UICC TNM classification 7th edition
(3) Unresectable
(4) Having indication of defenitive thoracic radiotherapy
(5) No prior chemotherapy or radiotherapy
(6) ECOG PS of 0 or 1
(7) PaO2 >= 70 Torr or SpO2 >= 93%
(8) Adequate organ function
(9) Expected the rest of life over 12 weeks
(10) Age of 20 to 70 years
(11) Written informed consent by patients

Key exclusion criteria

(1) active concomitant malignancy
(2) Infection, ileus, or gastrointestinal obstruction
(3) Uncontrolled peptic ulcer or diabetes
(4) Intestinal pneumonia or severe emphysema
(5) Severe drug allergy
(6) Concomitant use of other investigational drugs, warfarin, or flucytosine
(7) Positive of HBsAg
(8) Pregnancy or breast-feeding

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yuichiro Ohe

Organization

National Cancer Center Hospital

Division name

Department of Thoracic Oncology

Zip code


Address

5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan

TEL

03-3542-2511

Email

yohe@ncc.go.jp


Public contact

Name of contact person

1st name
Middle name
Last name Seiji Niho

Organization

National Cancer Center Hospital East

Division name

Department of Thoracic Oncology

Zip code


Address

6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan

TEL

04-7133-1111

Homepage URL


Email

siniho@east.ncc.go.jp


Sponsor or person

Institute

National Cancer Center Hospital East

Institute

Department

Personal name



Funding Source

Organization

AMED

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

Cancer Institute Hospital, Japanese Foundation for Cancer Research; Shizuoka Cancer Center

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

癌研究会有明病院、静岡県立静岡がんセンター、九州がんセンター、愛知県がんセンター中央病院、国立がん研究センター中央病院、関西医科大学附属枚方病院、横浜市立市民病院、兵庫県立がんセンター


Other administrative information

Date of disclosure of the study information

2013 Year 01 Month 31 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

Main results already published

Date of protocol fixation

2012 Year 12 Month 05 Day

Date of IRB

2012 Year 11 Month 01 Day

Anticipated trial start date

2013 Year 01 Month 04 Day

Last follow-up date

2019 Year 01 Month 16 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2019 Year 02 Month 19 Day


Other

Other related information



Management information

Registered date

2013 Year 01 Month 31 Day

Last modified on

2020 Year 12 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011616


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name