UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006913 |
|---|---|
| Receipt number | R000008036 |
| Scientific Title | Retrospective Analysis for Long-Term Survivors in advanced non-small cell lung cancer |
| Date of disclosure of the study information | 2011/12/20 |
| Last modified on | 2013/12/23 21:06:13 |
* 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
Retrospective Analysis for Long-Term Survivors in advanced non-small cell lung cancer
Acronym
Retrospective Analysis for Long-Term Survivors in advanced non-small cell lung cancer
Scientific Title
Retrospective Analysis for Long-Term Survivors in advanced non-small cell lung cancer
Scientific Title:Acronym
Retrospective Analysis for Long-Term Survivors in advanced non-small cell lung cancer
Region
| Japan |
Condition
Condition
Non-small Cell Lung Cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To retrospectively evaluate how clinical backgrounds and treatment histories will affect survival time of patients in whom the administration of gefitinib was response
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Overall survival
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients who diagnosed with advanced non-small cell lung cancer (NSCLC) and administered gefitinib until October 2010
2.Stage IIIB/IV at the time of diagnosis
3.Performance status (PS) 0-2 at the time of diagnosis
4.Patients who responded to gefitinib with PR or CR assessed in daily clinical practice
Key exclusion criteria
1.patients with curative surgical operation
2.patients with curative radiation therapy
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Fumio Imamura |
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name
Department of Respiratory Medicine
Zip code
Address
1-3-3 Nakamichi, Higashinari-ku, Osaka
TEL
06-6972-1181
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Fumio Imamura |
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name
Department of Respiratory Medicine
Zip code
Address
1-3-3 Nakamichi,Higashinari-ku, Osaka
TEL
06-6972-1181
Homepage URL
imamura-fu@mc.pref.osaka.jp
Sponsor or person
Institute
Kansai Respiratory Clinical Network Research Group
Institute
Department
Personal name
Funding Source
Organization
Astrazeneca
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
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
| 2011 | Year | 12 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.journals.elsevier.com/lung-cancer/
Number of participants that the trial has enrolled
Results
A total of 335 patients were recruited. Twenty-eight (8.4%) patients survived more than 5 years.Sixty-five and 93 patients received gefitinib as rechallenge and beyond progressive disease (BPD), respec-tively. A statistically significant difference in OS was observed between the patients who underwentgefitinib rechallenge and those who did not rechallenge (median: 1272 days vs. 774 days; p < 0.001), aresult supported by a DTRA. Patients treated with gefitinib BPD also showed a tendency of longer survival.Conclusions: Gefitinib rechallenge and BPD played a central role in long term survival of the patients whoinitially responded to gefitinib.
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
Completed
Date of protocol fixation
| 2011 | Year | 11 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2013 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2013 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2013 | Year | 01 | Month | 31 | Day |
Other
Other related information
After extracting information corresponding to the above items from the medical records of the subjects, a database will be created to summarize and analyze the information for retrospective evaluation. Attention must be paid not to extract personally identifiable information (name, medical record numbers, date of birth, etc.). The data will be anonymized at the time of submission to the representative research institution.
Management information
Registered date
| 2011 | Year | 12 | Month | 20 | Day |
Last modified on
| 2013 | Year | 12 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008036
