UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007765 |
|---|---|
| Receipt number | R000009149 |
| Scientific Title | A randomized phase II trial of docetaxelor pemetrexed with or without gefitinib in elderly advanced non-small cell lung cancer patients harboring activating EGFR mutation after failure of the therapy as first-line treatment. |
| Date of disclosure of the study information | 2012/04/16 |
| Last modified on | 2013/09/20 12:13:53 |
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Basic information
Public title
A randomized phase II trial of docetaxelor pemetrexed with or without gefitinib in elderly advanced non-small cell lung cancer patients harboring activating EGFR mutation after failure of the therapy as first-line treatment.
Acronym
A randomized phase II study of continuou gefitinib plus docetaxel or pemetrexed in elderly gefitinib responders (JMTO LC 12-01)
Scientific Title
A randomized phase II trial of docetaxelor pemetrexed with or without gefitinib in elderly advanced non-small cell lung cancer patients harboring activating EGFR mutation after failure of the therapy as first-line treatment.
Scientific Title:Acronym
A randomized phase II study of continuou gefitinib plus docetaxel or pemetrexed in elderly gefitinib responders (JMTO LC 12-01)
Region
| Japan |
Condition
Condition
non-small cell lung cancer
Classification by specialty
| Medicine in general | Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy of docetaxel or pemetrexed with continuation of gefitinib in NSCLC patients harboring activating EGFR mutation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Progression-free survival
Key secondary outcomes
Response Rate
Disease Control Rate
Overall survival
Safety
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
Group A: docetaxel or pemetrexed
Interventions/Control_2
Group B: docetaxel or pemetrexed plus gefitinib
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
| 70 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Histologically or cytologically confirmed non-squamous non-small lung cancer
2.Harboring activating EGFR mutation including exon 19 deletion mutation and/or L858R point mutation
3.Previously treated gefitinib as first-line treatment and had good response (CR, PR or SD for more than 6 months accroding to Jackman cliteria)
4.Maintained gefitinib administered according to regular treatment schedule for more than 3 months
5.Platinum-based doublet chemotherapy is not recommended
6.Advanced or metastatic NSCLC (Stage IIIB/IV) and unsuitable for radiotherapy
7.Patients with evaluable disease
8.PS:0-2 (ECOG)
9.70 years or older
10.Sufficient organ function
WBC >=4000/mm3
Neutrophil >=2000/mm3
Plt >=100000/mm3
Hb >=9.0 g/dL
Both AST and ALT <=100IU/L
Total bilirubin: <=1.5 mg/dl
Serum creatinine: <=1.2 mg/dl
SpO2>=93%
11.A life expectancy of 3 months or more
12.Submission of written informed consent
Key exclusion criteria
1.Patients including clients and employee or stuff of the participating medical institution who are involved in planning and conducting this study
2.Patients who relapsed in one year from the last day of adjuvant chemotherapy
3.Active infection (fever of 38.0 degrees centigrade or higher)
4.Patients with past history including acute interstitial pneumonia, pulmonary drug toxicity and radiation pneumonitis treated with corticosteroids
5.Interstitial pneumonia/ Pulmonary fibrosis
6.Patietns with ileus
7.Uncontrollable diarrhea
8.Active double cancer
9.Serious allergy history
10.Patients with refractory gastric ulcer or a duodenal ulcer
11.Uncontrollable massive,pleural effusion or cardiac effusion
12.Systemic administartion of corticosteroids
13.History of docetaxe or pemetrexed therapy
14.serious medical complications (uncontrollable pulmonary disease, heart disease, kidney disease, liver disease)
and inappropriate patients for this study judged by the physicians physician
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | The Japan-Multinational Trial Organization(JMTO) |
Organization
National Hospital Organization Kinki-chuo Chest Medical Center
Division name
Medical Oncology
Zip code
Address
1180 Nagasone-cho Kita-ku, Sakai City, Osaka
TEL
072-252-3021
asami@kch.hosp.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Asami |
Organization
National Hospital Organization Kinki-chuo Chest Medical Center
Division name
Medical Oncology
Zip code
Address
1180 Nagasone-cho Kita-ku, Sakai City, Osaka
TEL
072-252-3021
Homepage URL
asami@kch.hosp.go.jp
Sponsor or person
Institute
The Japan-Multinational Trial Organization(JMTO)
Institute
Department
Personal name
Funding Source
Organization
AstraZeneca
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
United States
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
JMTO LC 12-01
Org. issuing International ID_1
The Japan-Multinational Trial Organization(JMTO)
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 | 04 | Month | 16 | 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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 05 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 05 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 04 | Month | 16 | Day |
Last modified on
| 2013 | Year | 09 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009149
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