UMIN-ICDS Clinical Trial

Public title

Genetic Alterations and clinical record in surgically debulked OVarian cancer patients by Liquid biopsy And whole eXome analYsis

Acronym

GALAXY-OV trial

Scientific Title

Genetic Alterations and clinical record in surgically debulked OVarian cancer patients by Liquid biopsy And whole eXome analYsis

Scientific Title:Acronym

GALAXY-OV trial

Region

Japan

Condition

ovarian cancer

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Malignancy

Genomic information

YES

Narrative objectives1

To evaluate whether ctDNA status after tumor reduction surgery and during the course of treatment correlates with prognosis and treatment efficacy in ovarian cancer patients scheduled for interval debulking surgery (IDS).
Whole-exome sequencing (WES) will also be performed on tumor samples to establish a registry of the association between genetic changes detected in tumor tissue and blood samples and clinical course.

Basic objectives2

Others

Basic objectives -Others

TR studies with ctDNA analysis,Disease Registry database construction

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Progression-free Survival

Key secondary outcomes

Overall survival(OS), sensitivity and specificity of ctDNA for surgical completion, ctDNA positivity rate, ctDNA negativity rate, percentage of abnormal genes, and abnormal gene expression will be established and correlations of these outcomes with other clinicopathologic and molecular features and perioperative treatment will be analyzed in an exploratory manner.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

18

years-old

<=

Age-upper limit

Not applicable

Gender

Female

Key inclusion criteria

1.The applicant must have a histopathological diagnosis of ovarian cancer (including ovarian, fallopian tube, or peritoneal cancer).
2.Those who are scheduled to Interval debulking surgery for primary and metastatic lesions.
3.Patients who have received less than 4 cycles of preoperative adjuvant chemotherapy.
4.Tumor tissue formalin-fixed paraffin-embedded specimens obtained by biopsy prior to the start of preoperative adjuvant chemotherapy must be available for submission to this study.
5.The patient must have stage 3 or stage 4 disease in the comprehensive findings.
6.A person who is able to take oral intake.
7.Persons who are 18 years of age or older at the time of obtaining consent.
8.Those with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
9.The applicant must be free from severe impairment of major organs (bone marrow, heart, lungs, liver, kidney, etc.) and meet the following criteria
- Neutrophil count >=1,500/mm3
- Platelet count >= 100,000/mm3
- Hemoglobin >= 8.0 g/dL
- Serum creatinine <=1.5 x upper limit of normal (ULN)
- Total bilirubin <=1.5 x ULN
- ALT and AST <=2.5 x ULN, or <=5 times ULN if liver metastases present.
10.Persons who have given their written consent to participate in the research of their own free will after a full explanation of the research has been given to them prior to enrollment in the study.

Key exclusion criteria

1.Patients with a history of treatment with PARP inhibitors or bevacizumab.
2.Patients who plan to use bevacizumab for preoperative adjuvant chemotherapy.
3.Persons with a history of malignancy(*6)
(*6)Patients with a recurrence-free period of at least 5 years or with basal or spinous cell carcinoma of the skin, superficial bladder cancer, cervical cancer, carcinoma in situ (intraepithelial carcinoma) or intramucosal carcinoma equivalent lesions that are considered cured by local treatment may be enrolled.
4.Persons with active local or systemic infections requiring treatment.
5.Persons who are HBs antigen positive, HBc antibody positive(*7) or HCV antibody positive(*8)
(*7) HBc antibody positive, but HBV-DNA negative is acceptable for registration.
(*8) HCV antibody-positive but HCV-RNA-negative patients are eligible for registration.
6.Must be HIV antibody positive (HIV antibodies may be untested for registration).
7.Patients with a history of interstitial lung disease requiring treatment (interstitial pneumonia, pulmonary fibrosis, etc.) or extensive findings of these diseases on CT.
8.Patients with uncontrolled complications(*8).
(*8)Gastrointestinal bleeding, cardiac disease, glaucoma, diabetes, etc.
9.Patients receiving continuous systemic administration (oral or intravenous) of steroids (prednisolone equivalent of 10 mg/day or more for at least 2 weeks)
10.Persons who are judged to have difficulty enrolling in this study due to clinically problematic psychiatric disorders.
11.History of hemoptysis (sputum of 2.5 mL or more of fresh blood).
12.Pregnant or lactating women.
13.Other persons who are deemed by the physician in charge to be unsuitable for enrollment in this study.

Target sample size

150

Name of lead principal investigator

1st name	Kenichi
Middle name
Last name	Harano

Organization

National Cancer Center

Division name

Hospital East, Department of Medical Oncology

Zip code

277-8577

Address

6-5-1 Kashiwanoha, Kashiwa, Chiba

TEL

04-7133-1111

Email

kharano@east.ncc.go.jp

Name of contact person

1st name	Kenichi
Middle name
Last name	Harano

Organization

National Cancer Center

Division name

Hospital East, Department of Medical Oncology

Zip code

277-8577

Address

6-5-1 Kashiwanoha, Kashiwa, Chiba

TEL

04-7133-1111

Homepage URL

Email

galaxy-ov-jimukyoku@east.ncc.go.jp

Institute

National Cancer Center

Institute

Department

Personal name

Organization

Takeda Pharmaceutical Company Limited

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

The Ethics Committee at National Cancer Center

Address

5-1-1 Tsukiji, Chuo-ku, Tokyo

Tel

03-3542-2511

Email

irst@ml.res.ncc.go.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2023

Year

04

Month

03

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Open public recruiting

Date of protocol fixation

2023

Year

03

Month

15

Day

Date of IRB

2023

Year

03

Month

24

Day

Anticipated trial start date

2023

Year

06

Month

01

Day

Last follow-up date

2029

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Study Design:
The natural history of the clinical course will be followed, and clinical information and genetic analysis will be performed on biopsy specimens, tumor tissue collected from surgical specimens, and blood specimens.

Registered date

2023

Year

04

Month

03

Day

Last modified on

2023

Year

10

Month

03

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057831