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 2022/12/08 12:30:11

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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

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 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

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

No longer recruiting

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

2022 Year 12 Month 08 Day



Link to view the page

Value
https://center6.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