UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050438 |
|---|---|
| Receipt number | R000057444 |
| Scientific Title | The Prognostic Value of 18F-FDG PET/CT Taken Immediately After Completion of Radiotherapy for Lung Cancer Treated with Concurrent Chemoradiotherapy: Comparison between PET/CT taken after completion of adjuvant Durvalumab |
| Date of disclosure of the study information | 2023/05/01 |
| Last modified on | 2023/02/27 16:39:58 |
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Basic information
Public title
The Prognostic Value of 18F-FDG PET/CT Taken Immediately After Completion of Radiotherapy for Lung Cancer Treated with Concurrent Chemoradiotherapy: Comparison between PET/CT taken after completion of adjuvant Durvalumab
Acronym
The Prognostic Value of PET/CT Taken Immediately After Completion lung Cancer Concurrent Chemoradiotherapy
Scientific Title
The Prognostic Value of 18F-FDG PET/CT Taken Immediately After Completion of Radiotherapy for Lung Cancer Treated with Concurrent Chemoradiotherapy: Comparison between PET/CT taken after completion of adjuvant Durvalumab
Scientific Title:Acronym
The Prognostic Value of PET/CT Taken Immediately After Completion lung Cancer Concurrent Chemoradiotherapy
Region
| Japan |
Condition
Condition
non small cell lung cancer
Classification by specialty
| Pneumology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The Prognostic Value of F-18 fluorodeoxyglucose positron emission tomography/computed tomography (PET/CT) taken immediately after completion of radiotherapy in non small cell lung cancer patients is not well known.
The purpose of this study is to assess the prognostic value of PET/CT taken immediately after completion of radiotherapy in lung cancer patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Compare SUVmax, SUVpeak, SUVlbm, SUVbsa, TLG, and MTV,between PET/CT taken within one week of completion of chemoradiotherapy and PET/CT taken after completion of Durvalumab.Find the best method and cut of value for stratifying patients with viable tumours on PET/CT taken within one week of completion of chemoradiotherapy.
Key secondary outcomes
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
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
PET/CT taken within one week of completion of chemoradiotherapy
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients must have FDG-avid (SUVmax>4.0) and histologically or cytologically proven NSCLC
Patients must be clinical American Joint Committee on Cancer (AJCC) stage IIIA or IIIB (AJCC, 7th ed.) with non-operable disease
Patients with multiple, ipsilateral pulmonary nodules (T3 or T4) are eligible if a definitive course of daily fractionated RT is planned
FDG-PET/CT scan for staging and RT plan within 4 weeks prior to registration
Thoracic CT scan (IV contrast is recommended unless medically contraindicated) within 6 weeks prior to registration
CT scan of the brain (contrast is recommended unless medically contraindicated) or MRI of the brain within 6 weeks prior to registration
Pulmonary function tests, including diffusion capacity of carbon monoxide (DLCO), within 6 weeks prior to registration; patients must have forced expiratory volume in 1 second (FEV1) >= 1.2 L or >50% predicted without bronchodilator
Performance status 0-1
Absolute neutrophil count>1,500 cells/mm3 (within 2 weeks prior to registration)
Platelets > 100,000 cells/mm3 (within 2 weeks prior to registration)
Haemoglobin > 10.0 g/dL (use of transfusion or other intervention to achieve this is acceptable) (within 2 weeks prior to registration)
Serum creatinine within normal institutional limits or a creatinine clearance > 60 ml/min (within 2 weeks prior to registration)
Negative serum or urine pregnancy test within 3 days prior to registration for women of childbearing potential
Women of childbearing potential and male participants must agree to use a medically effective means of birth control throughout their participation in the treatment phase of the study
The patient must provide study-specific informed consent prior to study entry
Key exclusion criteria
Patients with any component of small cell lung carcinomaPatients with evidence of a malignant pleural or pericardial effusion
Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years
Prior systemic chemotherapy for the studied cancer (prior chemotherapy for a different cancer is allowable)
Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fieldsSevere, active co-morbidity, defined as follows:
Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
Transmural myocardial infarction within the last 6 months
Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
Acquired immune deficiency syndrome based upon current Centres for Disease Control definition
Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
Poorly controlled diabetes (defined as fasting glucose level > 200 mg/dL) despite attempts to improve glucose control by fasting duration and adjustment of medications
Patients with T4 disease with radiographic evidence of massive invasion of a large pulmonary artery and tumour causing significant narrowing and destruction of that artery
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | Anneyuko |
| Middle name | Ikeda |
| Last name | Saito |
Organization
Juntendo University Faculty of Medicine Urayasu Hospital
Division name
Radiation Oncology
Zip code
279-0021
Address
2-1-1 Tomoioka Urayasushi chibaken
TEL
047-353-3111
anne@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Anneyuko |
| Middle name | Ikeda |
| Last name | Saito |
Organization
Juntendo University Faculty of Medicine Urayasu Hospital
Division name
Radiation Oncology
Zip code
279-0021
Address
2-1-1 Tomoioka Urayasushi chibaken
TEL
047-353-3111
Homepage URL
anne@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University Faculty of Medicine Urayasu Hospital
Institute
Department
Personal name
Anneyuko I Saito
Funding Source
Organization
Juntendo University Faculty of Medicine Urayasu Hospital
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
IRB of Juntendo University
Address
2-1-1 Bunkyoku Tokyo
Tel
03-3813-3111
igakubu.rinri1@juntendo.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
| 2023 | Year | 05 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 11 | Month | 07 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 10 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 02 | Month | 27 | Day |
Last modified on
| 2023 | Year | 02 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057444
