BReast CAncer Genes(BRCA) Expressions in Metastatic Gastric Cancer

BRCA Gene Rearrangement Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03838406
• Other study ID #: 1771-001-287
• Status: Completed
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: January 2021
• Source: Chung-Ang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• BRCA Gene Rearrangement
• Stomach Neoplasms

Intervention

Genetic:
• BRCA 1
The investigators evaluated the incidence of BRCA loss in patients with advanced gastric cancer and observed the treatment outcome and prognosis.

Drug:
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Chung-Ang University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Chung-Ang University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	through study completion, an average of 1 year
Secondary	Progression free survival	the time from diagnosis to death by any cause and progression.	through study completion, an average of 1 year
Secondary	Overall survival	the time from diagnosis to death by any cause	through study completion, an average of 1 year