UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054402 |
|---|---|
| Receipt number | R000062142 |
| Scientific Title | Prospective observational study of patients with completely resected epidermal growth factor receptor mutation-positive non-small cell lung cancer (AURORA) (WJOG17023L) |
| Date of disclosure of the study information | 2024/06/01 |
| Last modified on | 2024/07/16 09:36:41 |
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Basic information
Public title
Prospective observational study of patients with completely resected epidermal growth factor receptor mutation-positive non-small cell lung cancer (AURORA) (WJOG17023L)
Acronym
AURORA
Scientific Title
Prospective observational study of patients with completely resected epidermal growth factor receptor mutation-positive non-small cell lung cancer (AURORA) (WJOG17023L)
Scientific Title:Acronym
AURORA
Region
| Japan |
Condition
Condition
non-small cell lung cancer
Classification by specialty
| Pneumology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the actual selection of adjuvant therapy after surgery for EGFR mutation-positive non-small cell lung cancer and the efficacy of each therapy, as well as the safety of osimertinib as a postoperative adjuvant therapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Disease-free 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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients with histologically confirmed non-small cell lung cancer.
2) Patients who are confirmed to be EGFR mutation-positive based on a tumor tissue sample or cytological sample (including uncommon mutation). However, an EGFR mutation test must have been performed before the date of confirmation of recurrence if the patient has started or completed postoperative adjuvant chemotherapy, or if the patient is being followed up without postoperative adjuvant chemotherapy and is enrolled after confirmation of recurrence.
3) Patients who have undergone anatomic lung resection (except wedge resection) with curative intent and were confirmed to be at pathological stage II to III (TNM classification [UICC 9th edition]).
4) R0, R0 (un), R1 (is), or R1 (cy+) has been pathologically confirmed based on a sample resected in surgery.
5) Patients who are >= 18 years at the time of informed consent.
6) ECOG performance status (PS) is 0 to 2 at the time of enrollment.
7) Patients who have had surgery within 56 weeks (392 days) (the same day of the week 56 weeks after the date of surgery is allowed for enrollment). Enrollment can be before or after the start of postoperative adjuvant chemotherapy.
8) Patients with no history of neoadjuvant therapy (chemotherapy, immunotherapy, molecular targeted therapy, radiotherapy, or combination of these) for the target non-small cell lung cancer.
9) Patients who have given written informed consent after receiving thorough explanation of the study details prior to this study enrollment.
Key exclusion criteria
1) Pregnant women, lactating women, women who may be pregnant at the moment, or persons who have no intention of using birth control.
2) Patients with double cancer requiring treatment at the time of enrollment (however, carcinoma in situ and lesions equivalent to intramucosal carcinoma that are clinically or pathologically confirmed are not included in double cancer even if they are untreated.)
3) Patients with concurrent psychiatric disease or symptom that, in the opinion of the treating physician, would make it difficult for them to participate in the study.
4) Persons who are judged by the treating physician to be inappropriate for safe implementation of this study for any other reason.
Target sample size
650
Research contact person
Name of lead principal investigator
| 1st name | Hirotsugu |
| Middle name | |
| Last name | Kenmotsu |
Organization
Shizuoka Cancer Center
Division name
Division of Thoracic Oncology
Zip code
411-0934
Address
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka 411-0934, Japan.
TEL
(+81)055-989-5222
h.kenmotsu@scchr.jp
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Ishizuka |
Organization
West Japan Oncology Group
Division name
WJOG datacenter
Zip code
556-0016
Address
Namba Plaza Bldg. 304-1-5-7, Motomachi Naniwa-ku, Osaka 556-0016 JAPAN
TEL
06-6633-7400
Homepage URL
https://www.wjog.jp/
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 Exploratory Research Institutional Review Board
Address
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka 411-0934, Japan.
Tel
055-989-5222
tansaku_office@scchr.jp
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
| 2024 | Year | 06 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 04 | Month | 30 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 30 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 16 | Day |
Last follow-up date
| 2036 | Year | 07 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Nothing particular
Management information
Registered date
| 2024 | Year | 05 | Month | 15 | Day |
Last modified on
| 2024 | Year | 07 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062142
