UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038366 |
|---|---|
| Receipt number | R000043722 |
| Scientific Title | Chemoradiation therapy using IMRT followed by durvalumab for locally advanced NSCLC: a multicenter prospective single arm study(WJOG12019L) |
| Date of disclosure of the study information | 2019/10/24 |
| Last modified on | 2024/04/26 09:07:25 |
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Basic information
Public title
Chemoradiation therapy using IMRT followed by durvalumab for locally advanced NSCLC: a multicenter prospective single arm study(WJOG12019L)
Acronym
IMRT trial
Scientific Title
Chemoradiation therapy using IMRT followed by durvalumab for locally advanced NSCLC: a multicenter prospective single arm study(WJOG12019L)
Scientific Title:Acronym
CRT using IMRT followed by durvalumab
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate efficacy (durvalumab induction rate, response rate, progression-free survival, and overall survival) and safety (incidence and severity of adverse events) regarding sequential therapy of CRT using IMRT followed by durvalumab for locally advanced NSCLC. We hypothesized enhanced local efficacy and reduced toxicity (especially, lower incidence of pneumonitis >=grade 2) by IMRT, resulting in improvement of durvalumab induction rate and therapeutic outcome.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Durvalumab induction rate (rate of cases where durvalumab can be introduced within 42 days after CRT completion)
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
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Written informed consent
2. 20<= aged <75 years old
3. Histologically or cytologically proven NSCLC
4. Unresectable and curable locally advanced NSCLC (stage III or recurrence after surgery)
5. Cases will receive CRT consisting of platinum doublets using IMRT (54-66Gy)
6. With measurable lesions (RECIST v1.1)
7. PS (ECOG) 0 or 1
8. In recurrent cases after surgery, adjuvant chemotherapy is permitted, but adjuvant RT is not.
9. No history of thoracic RT for any types of cancer, while chemotherapy and hormone therapy are permitted.
Key exclusion criteria
1. Active double cancer
2. Infection which requires systemic antibiotics
3. Obvious interstitial lung disease or pulmonary fibrosis by chest-CT
4. Uncontrolled comorbidities such as diabetes, hypertension, heart failure, arrythmia, thrombo-embolism, psychotic disease, liver cirrhosis, and/or renal failure)
5. HIV-associated disease
6. Prescription of systemic steroids or immunosuppressant
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | AKITO |
| Middle name | |
| Last name | HATA |
Organization
Kobe Minimally Invasive Cancer Center
Division name
Division of Thoracic Oncology
Zip code
650-0046
Address
8-5-1, Minatojima-nakamachi, Chuo-ku, Kobe
TEL
078-304-4100
akitohata@hotmail.com
Public contact
Name of contact person
| 1st name | Shinichiro |
| Middle name | |
| Last name | Nakamura |
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, JAPAN
TEL
06-6633-7400
Homepage URL
datacenter@wjog.jp
Sponsor or person
Institute
West Japan Oncology Group
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
Kobe Minimally Invasive Cancer Center
Address
8-5-1, Minatojima-nakamachi, Chuo-ku, Kobe
Tel
078-304-4100
akitohata@hotmail.com
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
| 2019 | Year | 10 | Month | 24 | 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
32
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
| 2019 | Year | 09 | Month | 23 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 15 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a prospective observational study to investigate relationship between sequential therapy of CRT using IMRT followed by durvalumab and improvement of efficacy/safety.
Management information
Registered date
| 2019 | Year | 10 | Month | 23 | Day |
Last modified on
| 2024 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043722
