UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041778 |
|---|---|
| Receipt number | R000047683 |
| Scientific Title | Local radiotherapy followed by maintenance combination immunotherapy for advanced non-small-cell lung cancer patients whose initial combination immunotherapy failed with oligo-progression: multicenter, phase II study |
| Date of disclosure of the study information | 2020/11/15 |
| Last modified on | 2024/03/17 14:05:10 |
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Basic information
Public title
Local radiotherapy followed by maintenance combination immunotherapy for advanced non-small-cell lung cancer patients whose initial combination immunotherapy failed with oligo-progression: multicenter, phase II study
Acronym
OLCSG2001
Scientific Title
Local radiotherapy followed by maintenance combination immunotherapy for advanced non-small-cell lung cancer patients whose initial combination immunotherapy failed with oligo-progression: multicenter, phase II study
Scientific Title:Acronym
OLCSG2001
Region
| Japan |
Condition
Condition
non-small-cell lung cancer
Classification by specialty
| Medicine in general | Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to exploratoryly evaluate the efficacy and safety of immune checkpoint inhibitor(ICI)+ cytotoxic chemotherapy continuation after sequential radiation therapy in patients with advanced non-small cell lung cancer with Oligo-PD following induction therapy with combination with ICI and cytotoxic chemotherapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
1-year survival rate
Key secondary outcomes
Overall survival, progression-free survival, safety, post-treatment status
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Other |
Interventions/Control_1
sequential radiation therapy followed by immune checkpoint inhibitor(ICI)+ cytotoxic chemotherapy continuation
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
-The patient has histologically or cytologically confirmed non-small cell lung cancer.
-The patient has clinical stage III, IV, or post-operative recurrent non-small cell lung cancer that is not amenable to radical resection or radical radiation therapy.
-The patient has Oligo-PD after treatment with an immune checkpoint inhibitor (ICI) plus platinum-based cytotoxic anticancer agent.
<The Oligo-PD is defined as meeting all four of the following.>
1.Two or more courses of ICI+chemo induction and two or more courses of maintenance therapy, and tumor reduction of SD or greater with reduction.
2.The lesions that do not result in PD on RECIST as a whole if they are not exacerbated after ICI+chemo maintenance therapy and there is no exacerbation of the lesions.
3.The lesion must have no more than 3 lesions, including brain metastases, that are not in contact or fused by CT or MRI, respectively. However, lymph node metastases will be treated as a single lesion if the radiotherapist determines that the area can be irradiated at once.
4.Cases of cancerous pleural effusion, cancerous pericarditis, exacerbation in lymphangitis or cases of cancerous meningitis complications are excluded.
-All of these Oligo-PDs are capable of additional radiation exposure.
-An ECOG performance status (PS) of 0 to 1.
-Major organ function is intact.
-The patient is judged to be alive for at least 3 months from the date of enrollment.
Key exclusion criteria
Patients with serious complications or history are excluded.
Target sample size
19
Research contact person
Name of lead principal investigator
| 1st name | Daijiro |
| Middle name | |
| Last name | Harada |
Organization
National Hospital Organization Shikoku Cancer Center
Division name
Department of Thoracic Oncology
Zip code
791-0280
Address
160 Minami-Umemoto-machi, Matsuyama-shi, Ehime
TEL
089-999-1111
harada.daijiro.kn@mail.hosp.go.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Miyata |
Organization
National Hospital Organization Shikoku Cancer Center
Division name
Clinical Research Promotion Department
Zip code
791-0280
Address
160 Minami-Umemoto-machi, Matsuyama-shi, Ehime
TEL
089-999-1111
Homepage URL
miyada.atsushi.gx@mail.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization Shikoku Cancer Center
Institute
Department
Personal name
Funding Source
Organization
none
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
National Hospital Organization Shikoku Cancer Center
Address
160 Minami-Umemoto-machi, Matsuyama-shi, Ehime
Tel
089-999-1111
miyada.atsushi.gx@mail.hosp.go.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
| 2020 | Year | 11 | Month | 15 | 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
3
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
| 2020 | Year | 09 | Month | 12 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 17 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 24 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2024 | Year | 10 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 09 | Month | 13 | Day |
Last modified on
| 2024 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047683
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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