UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003274 |
|---|---|
| Receipt number | R000003960 |
| Scientific Title | A phase II trial of gefitinib and concurrent radiation therapy for locally advanced non-small cell lung cancer patients harboring sensitive EGFR mutations. |
| Date of disclosure of the study information | 2010/03/01 |
| Last modified on | 2011/09/02 09:26:00 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A phase II trial of gefitinib and concurrent radiation therapy for locally advanced non-small cell lung cancer patients harboring sensitive EGFR mutations.
Acronym
A phase II trial of gefitinib and concurrent radiation therapy for locally advanced non-small cell lung cancer patients harboring sensitive EGFR mutations.
Scientific Title
A phase II trial of gefitinib and concurrent radiation therapy for locally advanced non-small cell lung cancer patients harboring sensitive EGFR mutations.
Scientific Title:Acronym
A phase II trial of gefitinib and concurrent radiation therapy for locally advanced non-small cell lung cancer patients harboring sensitive EGFR mutations.
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
YES
Objectives
Narrative objectives1
To assess the safety and efficacy of gefitinib and concurrent radiation therapy for locally advanced non-small cell lung cancer patients harboring sensitive EGFR mutations.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Safety
Key secondary outcomes
Adverse event rates,Response rate,Disease control rate, Progression free survival, Two-year survival rate
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
gefitinib with concurrent radiation therapy
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.Unresectable locally advanced NSCLC
2.Histologically or cytologically confirmed NSCLC
3.Patients harboring EGFR mutations (exon 19 deletion or L858R)
4.No prior medication (chemotherapy, radiation therapy or surgery) and stage IIIA or IIIB.
5.ECOG performance status (PS): 0-1
6. V20 <= 35%
7.Patients aged 20 years old or older
8.Adequate organ function.
WBC count >= 4,000/mm3,
Neutrophil count >= 2,000/mm3
Platelet count >= 100,000/mm3
hemoglobin >= 9.5g/dL
AST and ALT <= 100 IU/L
Bilirubine level <= 1.5 mg/dL
Serum creatinine <= 1.2 mg/dL
PaO2 >= 70 torr
9.Patients who are considered to survive for more than 3 months
10.Written informed consent
Key exclusion criteria
1.Patients with active severe infections
2.Significant interstitial pneumonitis
, pulmonary fibrosis on Chest CT
3.Contralateral hilar lymph node metastasis
4.Patietns with ileus
5.Patients with uncontrollable diarrhea
6.The presence of other concomitant cancers
7.Serious allergy history
8.Patients with total gastrectomy
9.Heavy smoking habit: (the number of cigarettes smoked daily) x (smoking period)> 400
10.Tumor infiltrating great vessels clearly
11.Patients harboring T790M mutation
12.Inappropriate patients for this study judged by the physicians
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinji Atagi |
Organization
National Hospital Organization Kinki-chuo Chest Medical Center
Division name
Clinical reserch center
Zip code
Address
1180 Nagasone-cho, Kita-ku, Sakai-city, Osaka591-8555 JAPAN
TEL
072-252-3021
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, Kitaku, Sakai, Osaka, Japan
TEL
072-252-3021
Homepage URL
Sponsor or person
Institute
National Hospital Organization
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization Headquarters Center
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
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
独立行政法人国立病院機構 国立病院、国立医療センター
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 03 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2010 | Year | 03 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 03 | Month | 01 | Day |
Last modified on
| 2011 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003960
