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BReast CAncer Genes(BRCA) Expressions in Metastatic Gastric Cancer

Primary Purpose

BRCA Gene Rearrangement

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

BRCA 1

Chemotherapy

About this trial

This is an interventional treatment trial for BRCA Gene Rearrangement focused on measuring Stomach cancer, Chemotherapy, FOLFOX, Capecitabine plus Oxalipatin (CAPOX)

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Metastatic gastric cancer( Adenocarcinoma)
Eastern Cooperative Oncology Group (ECOG) performance 0-2
one more measure lesion
White blood cell count (WBC) > 3000/ul , Platelet > 75,000/ul
Normal kidney function (serum creatinine < 1.5 ULN)
Normal Liver function (Aspartate aminotransferase (AST)/ Alanine aminotransferase (ALT) < 3 times of upper normal limit, if liver metastasis, AST/ALT < 5 times of upper normal limit)
life expectancy is more than 3 months
Conventional surgery that does not cause the transformation of the target lesion is allowed
The patient who voluntarily decided to participate in this study and agreed in writing

Exclusion Criteria:

Her-2 positive advanced gastric cancer
Central nervous system metastases requiring treatment with symptoms
Major uncontrolled cardiovascular disease (including myocardial infarction and congestive heart failure within 6 months)
Uncontrolled infection or other serious diseases
Patients with serious medical conditions or serious illnesses
Patient who is pregnant or lactating
Adjuvant chemotherapy before 6 months (patients who have not received platinum-based chemotherapy even if they are 6 months old can register)
In the past, if the primary lesion or target lesion was treated with radiation (if the recurred lesion is outside the range of radiation therapy)

Sites / Locations

Chung-Ang University College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

BRCA1 positive

BRCA1 negative

Arm Description

FOLFOX or CAPOX Chemotherapy FOLFOX : Day 1: Oxaliplatin 85mg/m2 IV + leucovorin 400mg/m2 IV + Fluorouracil (5-FU) 400mg/m2 IV Days 1 and 2: 5-FU 1200mg/m2 IV continuous infusion over 24 hours daily. Repeat cycle every 14 days. CAPOX: Day 1: Oxaliplatin 130mg/m2 IV Days 1-14: Capecitabine 1000mg/m2 orally twice daily. Repeat cycle every 21 days.

FOLFOX or CAPOX Chemotherapy FOLFOX : Day 1: Oxaliplatin 85mg/m2 IV + leucovorin 400mg/m2 IV + 5-FU 400mg/m2 IV Days 1 and 2: 5-FU 1200mg/m2 IV continuous infusion over 24 hours daily. Repeat cycle every 14 days. CAPOX: Day 1: Oxaliplatin 130mg/m2 IV Days 1-14: Capecitabine 1000mg/m2 orally twice daily. Repeat cycle every 21 days.

Outcomes

Primary Outcome Measures

Objective response rate

the proportion of patients who have a partial or complete response to therapy; it does not include stable disease and is a direct measure of drug tumoricidal activity.

Secondary Outcome Measures

Progression free survival

the time from diagnosis to death by any cause and progression.

Overall survival

the time from diagnosis to death by any cause

Full Information

NCT ID

NCT03838406

First Posted

February 7, 2019

Last Updated

January 25, 2021

Sponsor

Chung-Ang University

1. Study Identification

Unique Protocol Identification Number

NCT03838406

Brief Title

BReast CAncer Genes(BRCA) Expressions in Metastatic Gastric Cancer

Official Title

A Pilot Trial of Platinum Based Chemotherapy According to BRCA Expressions as First-line Chemotherapy in Patients With Metastatic Gastric Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Completed

Study Start Date

August 1, 2017 (Actual)

Primary Completion Date

December 31, 2019 (Actual)

Study Completion Date

December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chung-Ang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The investigators evaluated the incidence of BRCA loss in patients with advanced gastric cancer and observed the treatment outcome and prognosis according to BRCA loss. And the investigators evaluated the possibility of BRCA loss as a predictive and prognostic factor.

Detailed Description

Stomach cancer is still the leading cause of cancer deaths globally and is reported to be the second leading cause of cancer deaths in Korea (18.7%). Although the number of radical resection has increased due to the development of early diagnosis, many patients experience recurrence after radical resection. It is also diagnosed as a non - resectable disease locally advanced at the time of initial diagnosis, or with a metastasis. In patients with recurrent / metastatic gastric cancer, conventional palliative chemotherapy is the best treatment, and in advanced gastric cancer, combination therapy with fluoropyrimidine (fluorouracil, capecitabine, S1) and platinum (oxaliplatin, cisplatin). The progression-free survival was 3-5 months, and overall survival of 6-10 months in metastatic gastric cancer patients. The investigators evaluated the incidence of BRCA loss in patients with advanced gastric cancer and observed the treatment outcome and prognosis according to BRCA loss. And the investigators evaluated the possibility of BRCA loss as a predictive and prognostic factor.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

BRCA Gene Rearrangement

Keywords

Stomach cancer, Chemotherapy, FOLFOX, Capecitabine plus Oxalipatin (CAPOX)

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BRCA1 positive

Arm Type

Experimental

Arm Description

Arm Title

BRCA1 negative

Arm Type

Active Comparator

Arm Description

Intervention Type

Genetic

Intervention Name(s)

BRCA 1

Intervention Description

The investigators evaluated the incidence of BRCA loss in patients with advanced gastric cancer and observed the treatment outcome and prognosis.

Intervention Type

Drug

Intervention Name(s)

Chemotherapy

Other Intervention Name(s)

FOLFOX or CAPOX

Intervention Description

FOLFOX : Day 1: Oxaliplatin 85mg/m2 IV + leucovorin 400mg/m2 IV + Fluorouracil (5-FU) 400mg/m2 IV Days 1 and 2: 5-FU 1200mg/m2 IV continuous infusion over 24 hours daily. Repeat cycle every 14 days. CAPOX: Day 1: Oxaliplatin 130mg/m2 IV Days 1-14: Capecitabine 1000mg/m2 orally twice daily. Repeat cycle every 21 days.

Primary Outcome Measure Information:

Title

Objective response rate

Description

the proportion of patients who have a partial or complete response to therapy; it does not include stable disease and is a direct measure of drug tumoricidal activity.

Time Frame

through study completion, an average of 1 year

Secondary Outcome Measure Information:

Title

Progression free survival

Description

the time from diagnosis to death by any cause and progression.

Time Frame

through study completion, an average of 1 year

Title

Overall survival

Description

the time from diagnosis to death by any cause

Time Frame

through study completion, an average of 1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Metastatic gastric cancer( Adenocarcinoma) Eastern Cooperative Oncology Group (ECOG) performance 0-2 one more measure lesion White blood cell count (WBC) > 3000/ul , Platelet > 75,000/ul Normal kidney function (serum creatinine < 1.5 ULN) Normal Liver function (Aspartate aminotransferase (AST)/ Alanine aminotransferase (ALT) < 3 times of upper normal limit, if liver metastasis, AST/ALT < 5 times of upper normal limit) life expectancy is more than 3 months Conventional surgery that does not cause the transformation of the target lesion is allowed The patient who voluntarily decided to participate in this study and agreed in writing Exclusion Criteria: Her-2 positive advanced gastric cancer Central nervous system metastases requiring treatment with symptoms Major uncontrolled cardiovascular disease (including myocardial infarction and congestive heart failure within 6 months) Uncontrolled infection or other serious diseases Patients with serious medical conditions or serious illnesses Patient who is pregnant or lactating Adjuvant chemotherapy before 6 months (patients who have not received platinum-based chemotherapy even if they are 6 months old can register) In the past, if the primary lesion or target lesion was treated with radiation (if the recurred lesion is outside the range of radiation therapy)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

In Gyu Hwang

Organizational Affiliation

Chung-Ang University Hosptial, Chung-Ang University College of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Chung-Ang University College of Medicine

City

Seoul

ZIP/Postal Code

06973

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

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BReast CAncer Genes(BRCA) Expressions in Metastatic Gastric Cancer

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