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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000008366
Receipt No. R000009835
Scientific Title A phase II study of gefitinib with concurrent thoracic radiotherapy in patients with unresectable, stage III Non-Small Cell Lung Cancer harboring EGFR mutations.
Date of disclosure of the study information 2012/07/06
Last modified on 2019/07/12

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Basic information
Public title A phase II study of gefitinib with concurrent thoracic radiotherapy in patients with unresectable, stage III Non-Small Cell Lung Cancer harboring EGFR mutations.
Acronym A phase II study of gefitinib with TRT in patients with stage III NSCLC harboring EGFR mutations.
Scientific Title A phase II study of gefitinib with concurrent thoracic radiotherapy in patients with unresectable, stage III Non-Small Cell Lung Cancer harboring EGFR mutations.
Scientific Title:Acronym A phase II study of gefitinib with TRT in patients with stage III NSCLC harboring EGFR mutations.
Region
Japan

Condition
Condition Non-Small Cell Lung Cancer
Classification by specialty
Pneumology Hematology and clinical oncology Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To explore the efficacy and the tolerability of gefitinib with concurrent thoracic radiotherapy in patients with unresectable, stage III Non-Small Cell Lung Cancer harboring EGFR mutations.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Progression free survival rate at 2 years.
Key secondary outcomes Overall response rate, progression free survival rate at 1 year, progression free survival, survival rate at 1 year, survival rate at 2 years, overall survival, and safety.

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 An oral dose of 250mg of gefitinib is administered daily beginning on day 1, with once-daily thoracic radiotherapy delivered at 2 Gy per day to a total dose of 64 Gy.
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
75 years-old >
Gender Male and Female
Key inclusion criteria 1) Pathologically confirmed NSCLC
2) Treatment na&iuml;ve, unresectable stage III disease, whereas those with T3N1 desease, contralateral mediastinal lymph node metastasis, pulmonary metastasis, and atelectasis of the entire hemithorax were excluded
3) Harboring EGFR mutation (exon 19 deletion, and / or exon 21 L858R point mutation)
4) an age of 20-75 years
5) ECOG PS of 0 or 1
6)With evaluable target lesions as per RECIST ver. 1.1
7) With adequate organ function
8) Confirmed as eligible for the protocol defined radiotherapy by radiologists
9) Provided written informed consent
Key exclusion criteria 1) Harboring exon 20 T790M mutation.
2) Incapable of oral intake
3) With intestinal paralysis, or ileus
4) Chronic diarrhea
5)Exhibiting significant interstitial pneumonitis, or pulmonary fibrosis in the chest CT
6) Active infection
7) Positive for HBs antigen
8) Uncontrolled diabetes mellitus
9) Severe heart disease
10) Systemic treatment with steroids
11) Concomitant cancers within 5 years
12) Prior history of thoracic radiotherapy
13) History of sereous drug allegies
14) Pregnancy, breast feeding, or hesitation in contraception
15) Other conditions not suitable for this study
Target sample size 27

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Haruyasu Murakami
Organization Shizuoka Cancer Center
Division name Division of Thoracic Oncology
Zip code
Address 1007, Shimonagakubo, Nagaizumi-cho, Shizuoka, Japan
TEL 055-989-5222
Email ha.murakami@scchr.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shinichiro Nakamura
Organization West Japan Oncology Group
Division name WJOG datacenter
Zip code
Address Namba Plaza Bldg.304-1-5-7,Motomachi Naniwa-ku,Osaka 556-0016 JAPAN
TEL 06-6633-7400
Homepage URL
Email datacenter@wjog.jp

Sponsor
Institute West Japan Oncology Group
Institute
Department

Funding Source
Organization AstraZeneca K.K
Organization
Division
Category of Funding Organization Profit 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

Other administrative information
Date of disclosure of the study information
2012 Year 07 Month 06 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 28
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 No longer recruiting
Date of protocol fixation
2012 Year 07 Month 02 Day
Date of IRB
2012 Year 08 Month 27 Day
Anticipated trial start date
2013 Year 01 Month 24 Day
Last follow-up date
2020 Year 08 Month 20 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 07 Month 06 Day
Last modified on
2019 Year 07 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009835

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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