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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044470
Receipt No. 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 2021/06/08

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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
Obsterics 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
Email 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
Email okonogi.noriyuki@qst.go.jp

Sponsor
Institute National Institutes for Quantum and Radiological Science and Technology
Institute
Department

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
Email 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 Preinitiation
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
2021 Year 06 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050800

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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