UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044470 |
|---|---|
| Receipt number | R000050800 |
| Scientific Title | A phase Ib study of Durvalumab in combination with carbon-ion radiotherapy and weekly cisplatin for patients with locally advanced cervical cancer. An additional study for immunological prognostic factors |
| Date of disclosure of the study information | 2021/06/08 |
| Last modified on | 2024/06/13 06:59:33 |
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Basic information
Public title
A phase Ib study of Durvalumab in combination with carbon-ion radiotherapy and weekly cisplatin for patients with locally advanced cervical cancer.
An additional study for immunological prognostic factors
Acronym
A phase Ib study of Durvalumab in combination with carbon-ion radiotherapy and weekly cisplatin for patients with locally advanced cervical cancer.
An additional study for immunological prognostic factors
Scientific Title
A phase Ib study of Durvalumab in combination with carbon-ion radiotherapy and weekly cisplatin for patients with locally advanced cervical cancer.
An additional study for immunological prognostic factors
Scientific Title:Acronym
A phase Ib study of Durvalumab in combination with carbon-ion radiotherapy and weekly cisplatin for patients with locally advanced cervical cancer.
An additional study for immunological prognostic factors
Region
| Japan |
Condition
Condition
Cervical cancer
Classification by specialty
| Obstetrics and Gynecology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To explore immunological prognostic factors in a phase Ib study of Durvalumab (MEDI4736) in combination with carbon-ion radiotherapy and weekly cisplatin for patients with locally advanced cervical cancer.
Basic objectives2
Others
Basic objectives -Others
N/A
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
N/A
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
Female
Key inclusion criteria
1) Patients who have participated in a phase Ib study of Durvalumab in combination with carbon-ion radiotherapy and weekly cisplatin for patients with locally advanced cervical cancer (jRCT2031210083).
2) Patients whose participation in this study has been fully explained to them and for whom free and voluntary consent has been obtained in writing from them with full understanding.
Key exclusion criteria
Patients who are judged by the investigator or other physician to be unsuitable for participation in this study, such as those who are unlikely to comply with study procedures, restrictions, or requirements.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Noriyuki |
| Middle name | |
| Last name | Okonogi |
Organization
National Institutes for Quantum and Radiological Science and Technology
Division name
Department of Charged Particle Therapy Research
Zip code
263-8555
Address
4-9-1, Anagawa, Inage, Chiba
TEL
043-206-3306
okonogi.noriyuki@qst.go.jp
Public contact
Name of contact person
| 1st name | Noriyuki |
| Middle name | |
| Last name | Okonogi |
Organization
National Institutes for Quantum and Radiological Science and Technology
Division name
Department of Charged Particle Therapy Research
Zip code
263-8555
Address
4-9-1, Anagawa, Inage, Chiba
TEL
043-206-3306
Homepage URL
okonogi.noriyuki@qst.go.jp
Sponsor or person
Institute
National Institutes for Quantum and Radiological Science and Technology
Institute
Department
Personal name
Funding Source
Organization
AstraZeneca
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
Certified Review Board, National Institutes for Quantum and Radiological Science and Technology
Address
4-9-1, Anagawa, Inage, Chiba
Tel
043-206-4706
helsinki@qst.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
| 2021 | Year | 06 | Month | 08 | 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
Completed
Date of protocol fixation
| 2021 | Year | 05 | Month | 31 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 31 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Immunological prognostic factors will be analyzed based on blood samples and tumor tissue samples from patients enrolled in the study.
Management information
Registered date
| 2021 | Year | 06 | Month | 08 | Day |
Last modified on
| 2024 | Year | 06 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050800
