UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008366 |
|---|---|
| Receipt number | 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 | 2023/05/17 11:26:15 |
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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 naïve, 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 | Haruyasu |
| Middle name | |
| Last name | Murakami |
Organization
Shizuoka Cancer Center
Division name
Division of Thoracic Oncology
Zip code
411-8777
Address
1007, Shimonagakubo, Nagaizumi-cho, Shizuoka, Japan
TEL
055-989-5222
ha.murakami@scchr.jp
Public contact
Name of contact person
| 1st name | Shinichiro |
| Middle name | |
| Last name | Nakamura |
Organization
West Japan Oncology Group
Division name
WJOG datacenter
Zip code
411-8777
Address
Namba Plaza Bldg.304-1-5-7,Motomachi Naniwa-ku,Osaka 556-0016 JAPAN
TEL
06-6633-7400
Homepage URL
datacenter@wjog.jp
Sponsor or person
Institute
West Japan Oncology Group
Institute
Department
Personal name
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
Shizuoka Cancer Center Certified Review Board
Address
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka
Tel
055-989-5222
rinsho_office@scchr.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
jRCTs041180080
Org. issuing International ID_1
Ministry of Health, Labour and Welfare
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
https://jrct.niph.go.jp/latest-detail/jRCTs041180080
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/34116229/
Number of participants that the trial has enrolled
28
Results
Among unresectable locally-advanced NSCLC patients with EGFR mutation, gefitinib with concurrent thoracic radiotherapy showed manageable safety profiles, but did not improve PFS rate at 2 years.
Results date posted
| 2023 | Year | 05 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A total of 28 patients were enrolled and 27 were eligible. Of those, median age was 67 (range, 45-74); male/female 7/20; never/current or former smoker 15/12; ECOG performance status 0/1 19/8; EGFR exon 19 deletion/exon 21 L858R 13/14; and c-stage IIIA/IIIB 14/13.
Participant flow
Between Aug 2012 and Nov 2017, 28 patients were enrolled and 27 were eligible and treated with the protocol therapy.
Adverse events
Pneumonitis was frequently observed, but all events were mild (Grade 1 59.2% and Grade 2 29.6%). Severe adverse events Grade 3-4 were increased ALT (59.3%), increased AST (37.0%), fatigue (3.7%), skin reaction (3.7%) and appetite loss (3.7%). Most of the severe adverse events was manageable liver dysfunction, and there was no treatment-related death.
Outcome measures
In this study, we set PFS rate at two-years as the primary endpoint. For sample size calculation, we assumed an improvement of PFS rate at 2 years from 20% to 40%. As a result, PFS rate at 2 years by independent review was 29.6% (one-sided 95% confidence interval [CI]: 17.6%-), which did not meet the primary endpoint. ORR was 81.5% (95%CI: 63.3-91.3%). Median PFS was 18.6 months (95% CI: 12.0-24.5 months) and PFS rates at one-year was 66.7% (95% CI: 45.7-81.1%). Median OS was 61.1 months (95%CI: 38.1 months to not reached) and survival rate at one- and two-year was 100.0% and 96.3%, respectively.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2023 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009835
