UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006252 |
|---|---|
| Receipt number | 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 | 2022/01/06 20:06:31 |
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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
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
secretariat@fiverings.co.jp
Sponsor or person
Institute
Clinical trial coordinating committee for WJOG 6410L investigator-initiated multicenter clinical trial
Institute
Department
Personal name
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
-
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
https://ascopubs.org/doi/full/10.1200/JCO.21.01729
Publication of results
Published
Result
URL related to results and publications
https://ascopubs.org/doi/full/10.1200/JCO.21.01729
Number of participants that the trial has enrolled
234
Results
The median DFS was 35.9 and 25.1 months in the gefitinib and cis/vin groups, respectively. However, Kaplan-Meier curves crossed around 4 years after surgery with no statistically significant difference. OS was also not different, with the 5-year OS rates being 78.0% and 74.6% in the gefitinib and cis/vin groups, respectively. Treatment-related deaths occurred in 0 and three patients in the gefitinib and cis/vin groups, respectively.
Results date posted
| 2022 | Year | 01 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 11 | Month | 02 | Day |
Baseline Characteristics
Please see:
J Clin Oncol. 2021 Nov 2;JCO2101729. doi: 10.1200/JCO.21.01729.
Participant flow
Please see:
J Clin Oncol. 2021 Nov 2;JCO2101729. doi: 10.1200/JCO.21.01729.
Adverse events
Please see:
J Clin Oncol. 2021 Nov 2;JCO2101729. doi: 10.1200/JCO.21.01729.
Outcome measures
Please see:
J Clin Oncol. 2021 Nov 2;JCO2101729. doi: 10.1200/JCO.21.01729.
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
| 2022 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007398
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