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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006252
Receipt No. R000007398
Scientific Title A randomized phase III trial of adjuvant gefitinib versus cisplatin and vinorelbine in completely resected (stage II-III) non-small cell lung cancer (NSCLC) patients with mutated EGFR (investigator-initiated multicenter clinical trial)
Date of disclosure of the study information 2011/09/03
Last modified on 2021/03/26

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Basic information
Public title A randomized phase III trial of adjuvant gefitinib versus cisplatin and vinorelbine in completely resected (stage II-III) non-small cell lung cancer (NSCLC) patients with mutated EGFR (investigator-initiated multicenter clinical trial)
Acronym Adjuvant phase III trial of gefitinib compared with cisplatin/vinorelbine in completely resected (stage II-III) NSCLC patients with mutated EGFR
Scientific Title A randomized phase III trial of adjuvant gefitinib versus cisplatin and vinorelbine in completely resected (stage II-III) non-small cell lung cancer (NSCLC) patients with mutated EGFR (investigator-initiated multicenter clinical trial)
Scientific Title:Acronym Adjuvant phase III trial of gefitinib compared with cisplatin/vinorelbine in completely resected (stage II-III) NSCLC patients with mutated EGFR
Region
Japan

Condition
Condition Patients with completely resected pathological stage II or III non-small cell lung cancer with mutated EGFR
Classification by specialty
Pneumology Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The primary objective is to verify the superiority of adjuvant chemotherapy with gefitinib to adjuvant chemotherapy with cisplatin and vinorelbine in terms of disease-free survival (DFS) for the preventive effect on recurrence in patients with completely resected stage II or III non-small cell lung cancer with EGFR mutation
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes Disease free survival
Key secondary outcomes Overall survival
Safety and tolerability
Type of recurrence

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
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 gefitinib
Interventions/Control_2 cisplatin and vinorelbine combination therapy
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) Patients for whom non-small cell lung cancer is confirmed histologically
2) Patients underwent at least lung lobectomy including elective or non-elective dissection of hilar or mediastinal lymph node
3) Complete resection is judged (Complete resection is defined to be the situation that tumor is completely removed grossly at the time of operation and tumor cells are not noted pathologically on the resection line.)
4) The pathological stage is IIA, IIB, IIIA or IIIB.
5) For primary tumor, there is either of deletion of exon19 or exon21 L858R in EGFR gene mutation AND there is no T790M gene mutation. (The commercial test method now in Japan should be used.)
6) At the time of enrollment, patients should be at least 20 years old and younger than 75 years old.
7) PS (ECOG; Eastern Cooperative Oncology Group) is 0-1.
8) Trial treatment can be started within 6 to 10 weeks after resection.
9) Functions of the bone marrow, liver, kidney, and lung etc are maintained, satisfying the following conditions. (The following data should be the ones within 2 weeks before enrollment. The same day of the week 2 weeks before enrollment can be included.)
*Hemoglobin concentration>=10 g/dL
*Neutrophil count >=2,000/mm3
*Platelet count >=100,000/mm3
*AST/ALT <=2.0 X ULN of normal values in each institution
*Total bilirubin <=1.5 mg/dL
*Serum creatinine <=1.2 mg/dL
*Dermal toxicity <=Grade 2
*SpO2 >=95%
10) After the details of the trial are explained sufficiently before enrollment in this trial, written consent by patients themselves should be obtained.
Key exclusion criteria 1) Patients with interstitial pneumonia or pulmonary fibrosis on chest plain CT
2) Patients with a history of acute lung injury, sporadic pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, or drug-induced pneumonia
3) Patients with active double cancer
4) Pregnant or breast-feeding females and females who have a possibility of pregnancy or lactation or patients who does not intend to use birth control
5) Patients with poor-controlled diabetes mellitus
6) Patients with active serious infections (such as the patients showing fever at >=38.0 degrees Celsius)
7) Patients with other serious concomitant diseases (gastrointestinal bleeding, cardiovascular disease) or focus of infection in the thoracic cavity
8) Patients with serious hypersensitivity to drugs
9) Patients undergoing treatment with an anticancer agent or radiotherapy in the last 5 years,except for Carcinoma in situ or intramucosal carcinoma with radiation therapy.
(intrathoracic administration of PICIBANIL is not regarded as administration of an anticancer agent)
10) Patients judged to be difficult to be enrolled in this trial because of clinically problematic psychiatric disorders
11) Patients administered the other investigational product within 12 weeks before random allocation
12) Other patients judged to be ineligible for safe implementation of this trial by the investigator or sub-investigator
Target sample size 230

Research contact person
Name of lead principal investigator
1st name Hirohito
Middle name
Last name Tada
Organization Suita Tokushukai Hospital
Division name Cancer Center
Zip code 565-0814
Address 21-1, Senrioka-nishi, Suita-city, Osaka 565-0814 Japan
TEL 06-6878-1110
Email htada@asahi.email.ne.jp

Public contact
Name of contact person
1st name Hiroshi
Middle name
Last name Miyamoto
Organization Secretariat of Clinical trial coordinating committee for WJOG 6410L investigator-initiated multicent
Division name (non)
Zip code 530-0044
Address Urban Ace Higashitenma-BLDG, 1-1-19, Higashitenma, Kita-ku, Osaka 530-0044 Japan
TEL 06-6358-7110
Homepage URL
Email secretariat@fiverings.co.jp

Sponsor
Institute Clinical trial coordinating committee for WJOG 6410L investigator-initiated multicenter clinical trial
Institute
Department

Funding Source
Organization AstraZeneca K.K.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization JAPAN

Other related organizations
Co-sponsor West Japan Oncology Group
Name of secondary funder(s)

IRB Contact (For public release)
Organization Osaka City General Hospital IRB
Address 2-13-22, Miyakojima Hon-Dori, Miyakojima-ku,Osaka-shi
Tel 06-6929-1221
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 2011年8月19日

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2011 Year 09 Month 03 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 234
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
2011 Year 04 Month 27 Day
Date of IRB
2011 Year 06 Month 24 Day
Anticipated trial start date
2011 Year 09 Month 01 Day
Last follow-up date
2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 08 Month 30 Day
Last modified on
2021 Year 03 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007398

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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