UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022431 |
|---|---|
| Receipt number | R000025769 |
| Scientific Title | Single-arm phase II study of aggressive local therapy in combination with systemic chemotherapy for stageIV non-small cell carcinoma not harboring EGFR mutation and ALK fusion gene with oligometastases |
| Date of disclosure of the study information | 2016/06/01 |
| Last modified on | 2021/11/08 11:12:02 |
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Basic information
Public title
Single-arm phase II study of aggressive local therapy in combination with systemic chemotherapy for stageIV non-small cell carcinoma not harboring EGFR mutation and ALK fusion gene with oligometastases
Acronym
CURE-OLIGO
Scientific Title
Single-arm phase II study of aggressive local therapy in combination with systemic chemotherapy for stageIV non-small cell carcinoma not harboring EGFR mutation and ALK fusion gene with oligometastases
Scientific Title:Acronym
CURE-OLIGO
Region
| Japan |
Condition
Condition
Non-small Cell Lung Cancer
Classification by specialty
| Pneumology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate prolonging overall survival for patients with oligometastases stage IV non-small cell carcinoma, when combine standard chemotherapy and local therapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Two-year survival rate
Key secondary outcomes
-Overall Survival
-Progression Free Survival
-Adverse Event
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 | Other |
Interventions/Control_1
Platinum doublet + thoracic radio therapy
Surgery for oligometastases
Radiotherapy for oligometastases
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
| 74 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Aged 20-74 and Informed consent
2)ECOG PS 0-1
3)Stage IV non-small cell lung cancer
4)EGFR wild type and ALK negative or not detected
5)Only one metastasis legion (pleural effusion, cardiac effusion, pleural dissemination, peritoneal dissemination, and/or ascites are ineligible). However, resectable brain metastasis or brain metastasis that have adaptation of the gamma knife are allowed to four.
6)Curable concurrent chemoradiotherapy are available.
7)At least 8 weeks from local treatment completion for metastasis or no treatment.
Key exclusion criteria
1) Patients with pleural effusion, cardiac effusion, pleural dissemination, peritoneal dissemination, and/or ascites
2) Patients who are ineligible to treat with thoracic radiotherapy due to interstitial pneumonitis and/or severe COPD
Target sample size
55
Research contact person
Name of lead principal investigator
| 1st name | Takaaki |
| Middle name | |
| Last name | Tokitou |
Organization
Kurume University School of Medicine
Division name
Division of Respirology, Neurology, and Rheumatology, Department of Internal Medicine
Zip code
830-0011
Address
67 Asahi-machi, Kurume, Fukuoka
TEL
0942-31-7560
kitou_takaaki@kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | Takaaki |
| Middle name | |
| Last name | Tokitou |
Organization
Kurume University School of Medicine
Division name
Division of Respirology, Neurology, and Rheumatology, Department of Internal Medicine
Zip code
830-0011
Address
67 Asahi-machi, Kurume, Fukuoka
TEL
0942-31-7560
Homepage URL
kitou_takaaki@kurume-u.ac.jp
Sponsor or person
Institute
Thoracic Oncology Research Group
Institute
Department
Personal name
Funding Source
Organization
Thoracic Oncology Research Group
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kurume University ethical committee
Address
67 Asahi-machi, Kurume, Fukuoka
Tel
0942-31-7560
kensui@kurume-u.ac.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
| 2016 | 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
19
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
| 2016 | Year | 05 | Month | 06 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 16 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2022 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 11 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 05 | Month | 24 | Day |
Last modified on
| 2021 | Year | 11 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025769
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