BReast CAncer Genes(BRCA) Expressions in Metastatic Gastric Cancer

NCT ID: NCT03838406

Last Updated: 2021-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-01
• Study Completion Date: 2019-12-31

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.

Conditions

BRCA Gene Rearrangement

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BRCA1 positive

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.

Group Type: EXPERIMENTAL

BRCA 1

Intervention Type: GENETIC

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

Chemotherapy

Intervention Type: DRUG

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.

BRCA1 negative

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.

Group Type: ACTIVE_COMPARATOR

BRCA 1

Intervention Type: GENETIC

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

Chemotherapy

Intervention Type: DRUG

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.

Interventions

BRCA 1

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

Intervention Type: GENETIC

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.

Intervention Type: DRUG

Other Intervention Names

FOLFOX or CAPOX

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)

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chung-Ang University

OTHER

Sponsor Role: lead

Responsible Party

In Gyu Hwang

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

In Gyu Hwang

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Chung-Ang University College of Medicine

Seoul, , South Korea

Countries

South Korea

Other Identifiers

1771-001-287

Identifier Type: -

Identifier Source: org_study_id