UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043474
Receipt number R000049618
Scientific Title A historical cohort study to examine the safety and efficacy of olaparib maintenance therapy after initial treatment for advanced ovarian cancer
Date of disclosure of the study information 2021/04/01
Last modified on 2022/09/02 12:39:37

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Basic information

Public title

A historical cohort study to examine the safety and efficacy of olaparib maintenance therapy after initial treatment for advanced ovarian cancer

Acronym

JGOG3027

Scientific Title

A historical cohort study to examine the safety and efficacy of olaparib maintenance therapy after initial treatment for advanced ovarian cancer

Scientific Title:Acronym

JGOG3027

Region

Japan


Condition

Condition

Ovarian cancer

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The primary objective of the study is to evaluate the details, safety, and efficacy of olaparib maintenance therapy in patients with newly diagnosed advanced ovarian cancer (including fallopian tube cancer and primary peritoneal cancer) in Japan, and this study's secondary objective is to conduct a fact-finding survey on treatment given after the olaparib maintenance therapy.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Incidence of adverse events in patients who received olaparib maintenance therapy for newly diagnosed advanced ovarian cancer

Key secondary outcomes

1. Progression-free survival (PFS)
2. Overall survival (OS)
3. Details and effect of treatments given after olaparib maintenance therapy for first-relapsed ovarian cancer
4. Therapeutic effect (treatment period) and adverse events of PARP inhibitor re-administration for platinum-sensitive first-relapsed ovarian cancer
5. Incidence of secondary cancer


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

18 years-old <=

Age-upper limit


Not applicable

Gender

Female

Key inclusion criteria

1.Female patients with newly diagnosed, histologically confirmed, advanced (International Federation of Gynecology and Obstetrics FIGO stage III-IV) BRCA mutated ovarian cancer, primary peritoneal cancer and/or fallopian tube cancer who have completed first-line, platinum-based chemotherapy
2.Patients with complete or partial response after initial treatment with platinum-based combination chemotherapy
3.Patients in which olaparib maintenance therapy was started between June 2019 and March 2012
4.Patients aged 18 years or older (without upper age limit) at the time of enrollment
5. Patients must have a tissue biopsy or tumor debulking surgery
6. Platinum-based chemotherapy course must have consisted of a minimum of six treatment cycles and a maximum of nine; however, if platinum-based therapy must be discontinued early as a result of toxicities specifically related to the platinum regimen, patients must have received a minimum of four cycles of the platinum regimen
7. Patients must be started olaparib maintenance therapy within 8 weeks after their last dose of chemotherapy (last dose is the day of the last infusion)
8. Patients must have normal organ and bone marrow function
9. Eastern Cooperative Oncology Group performance status 0-1
10. Patients must have a life expectancy 16 weeks or more

Key exclusion criteria

1. Patients who have not confirmed a complete response (CR) or partial response (PR) by diagnostic imaging after initial treatment with platinum-based combination chemotherapy
2. Patients with early stage disease (FIGO Stage I, IIA, IIB, or IIC)
3. Patients who have had drainage of their ascites before olaparib maintenance therapy
4. Patients participating in other clinical studies
5. Patients with active double cancer
6. Persistent toxicities (Common Terminology Criteria for Adverse Events grade 2 or more) caused by previous cancer therapy, excluding alopecia
7. Patients with myelodysplastic syndrome/acute myeloid leukemia
8. Previous allogeneic bone marrow transplant
9. Patients with symptomatic uncontrolled brain metastases
10. Patients who were previously treated with poly (ADP-ribose) polymerase (PARP) inhibitors before olaparib maintenance therapy
11. Patients in which a molecular-targeted drug or immune checkpoint inhibitor is administered at the start of olaparib maintenance therapy (patients in which administration has been completed before the start of olaparib maintenance therapy can be registered)
12. BRCA1 and/or BRCA2 mutations that are considered to be non-detrimental and variant of uncertain significance (VUS)
13. Patients disqualified from participation in the study by the investigator

Target sample size

300


Research contact person

Name of lead principal investigator

1st name Terumi
Middle name
Last name Tanigawa

Organization

The Cancer Institute Hospital of JFCR

Division name

Gynecologic Oncology

Zip code

135-8550

Address

3-8-31, Ariake, Koto, Tokyo 135-8550, Japan

TEL

03-3520-0111

Email

terumi.tanigawa@jfcr.or.jp


Public contact

Name of contact person

1st name Terumi
Middle name
Last name Tanigawa

Organization

The Cancer Institute Hospital of JFCR

Division name

Gynecologic Oncology

Zip code

135-8550

Address

3-8-31, Ariake, Koto, Tokyo 135-8550, Japan

TEL

03-3520-0111

Homepage URL


Email

terumi.tanigawa@jfcr.or.jp


Sponsor or person

Institute

Japanese Gynecologic Oncology Group (JGOG)

Institute

Department

Personal name



Funding Source

Organization

Japanese Gynecologic Oncology Group (JGOG)

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Japanese Gynecologic Oncology Group

Address

4F, Komatsu Building, 6-22, Kagurazaka, Shinjuku-ku, Tokyo, 162-0825, Japan

Tel

03-5206-1982

Email

info@jgog.gr.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 04 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

No longer recruiting

Date of protocol fixation

2021 Year 02 Month 19 Day

Date of IRB

2021 Year 08 Month 04 Day

Anticipated trial start date

2021 Year 04 Month 01 Day

Last follow-up date

2026 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Adverse events and prognosis in patients with newly diagnosed advanced ovarian cancer (including fallopian tube cancer and primary peritoneal cancer) who received olaparib monotherapy


Management information

Registered date

2021 Year 03 Month 01 Day

Last modified on

2022 Year 09 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049618


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name