UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015949 |
|---|---|
| Receipt number | R000018280 |
| Scientific Title | A Prospective, Multi-center Phase II Trial on the Efficacy and Safety of Low-dose Erlotinib Monotherapy for Frail Patients with EGFR Mutation-positive, Non-small Cell Lung Cancer(TORG1425) |
| Date of disclosure of the study information | 2014/12/15 |
| Last modified on | 2020/05/15 14:48:14 |
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Basic information
Public title
A Prospective, Multi-center Phase II Trial on the Efficacy and Safety of Low-dose Erlotinib Monotherapy for Frail Patients with EGFR Mutation-positive, Non-small Cell Lung Cancer(TORG1425)
Acronym
Low-dose Erlotinib for Frail Patients with EGFR Mutation-positive Non-Small Cell Lung Cancer(TORG1425)
Scientific Title
A Prospective, Multi-center Phase II Trial on the Efficacy and Safety of Low-dose Erlotinib Monotherapy for Frail Patients with EGFR Mutation-positive, Non-small Cell Lung Cancer(TORG1425)
Scientific Title:Acronym
Low-dose Erlotinib for Frail Patients with EGFR Mutation-positive Non-Small Cell Lung Cancer(TORG1425)
Region
| Japan |
Condition
Condition
Non-small Cell Lung Cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate efficacy and safety of low dose erlotinib for frail patients with advanced or recurrent non-small cell lung cancer with EGFR mutation who are concerned about increase toxicities by standard chemotherapy.
Basic objectives2
Others
Basic objectives -Others
Safety, Efficacy
PK, PD
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Response Rate
Key secondary outcomes
-Disease Control Rate
-Response Rate containing SD patients after dose escalation
-Safety
-Progression Free Survival
-Overall Survival
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
Erlotinib treatment
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) patients with pathologically or proven non-small cell lung cancer
2) patients having EGFR mutation (exon 19 or Exon 21)
3) patients with stage IIIB or IV who are not candidates for curative radiotherapy
4) patients without prior chemotherapy for lung cancer and who satisfies either of the followings;
i) aged > 80 years old
ii) aged 75 - 80 years old and > 6 points Charlson comorbidity index or > P. S. 1
iii) aged 20-74 years old and > 6 points Charlson comorbidity index or > P. S. 2
5) patients who have measurable lesions by RECIST v.1.1
6) adequate laboratory findings as below(within 2 weeks prior registration);
- neutrophil > 1,000/mm3
- hemoglobin > 8.0g/dl
- platelet > 75,000/mm3
- total bilirubin: within 3 times of upper normal limit
- AST, ALT: within 5 times of upper normal limit
- SpO2 > 90%(oxygen dosage or not)
7) signed informed consent
8) life expectance more than 4 weeks
Key exclusion criteria
1) prior EGFR-TKI
2) active concomitant malignancy
3) concomitant brain metastasis require radiotherapy
4) interstitial pneumonia or lung fibrosis evident on CT
5) symptomatic ophthalmologic disease
6) patients having clinically important ophthalmic disorder
7) patients having clinically important neuropsychiatric disorder
8) pregnant or lactating women or those who declined contraception
9) patients judged to be not suitable by the attending physician
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiko Yamada |
Organization
Kurume University School of Medicine
Division name
Division of Respirology, Neurology, and Rheumatology, Department of Internal Medicine
Zip code
Address
67 Asahi-machi, Kurume, Fukuoka
TEL
0942-31-7560
kayamada@med.kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shingo Miyamoto |
Organization
Japanese Red Cross Medical Center
Division name
Division of Chemotherapy Department of Internal Medicine
Zip code
Address
4-1-22 Hiroo, Shibuya-ku, Tokyo
TEL
03-3400-1311
Homepage URL
torg1425@med.jrc.or.jp
Sponsor or person
Institute
NPO Thoracic Oncology Research Group
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2014 | Year | 12 | Month | 15 | Day |
Related information
URL releasing protocol
-
Publication of results
Published
Result
URL related to results and publications
https://jamanetwork.com/journals/jamaoncology/article-abstract/2765756
Number of participants that the trial has enrolled
80
Results
An independent review committee confirmed a significant ORR of 60.0%(90% CI, 50.2%-69.2%). The disease control rate was 90.0%(90% CI, 82.7%-94.9%), median progression-free survival was 9.3 months (95%CI, 7.2-11.4 months), and median overall survival was 26.2 months (95%CI, 21.9-30.4 months).
Results date posted
| 2020 | Year | 05 | Month | 15 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 05 | Month | 14 | Day |
Baseline Characteristics
Eighty patients were enrolled, with a median (range) age of 80 (49-90) years; 54 (68%) were men.
Participant flow
-
Adverse events
Mild adverse events were observed in some participants, with few patients exhibiting grade 3 or greater adverse events. Low-dose erlotinib treatment was temporarily suspended for 10 patients owing to adverse events. Five of 80 patients (6%) had their erlotinib dose reduced to 25mg because of oral mucositis, paronychia, erythema multiforme, diarrhea, and anorexia.Two patients discontinued treatment because of adverse events (cutaneous ulcer and bone
infection, and oral mucositis, respectively).
Outcome measures
-
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 10 | Month | 04 | Day |
Date of IRB
| 2014 | Year | 12 | Month | 16 | Day |
Anticipated trial start date
| 2015 | Year | 01 | Month | 07 | Day |
Last follow-up date
| 2018 | Year | 10 | 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
| 2014 | Year | 12 | Month | 15 | Day |
Last modified on
| 2020 | Year | 05 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018280
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