Clinical Trial: NCT03838406 - My Cancer Genome

NCT03838406

Description:

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.

Related Conditions:

Gastric Adenocarcinoma

Recruiting Status:

Completed

Phase:

N/A

URL:

https://clinicaltrials.gov/show/NCT03838406

Trial Eligibility

Document

Title

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

Clinical Trial IDs

ORG STUDY ID: 1771-001-287
NCT ID: NCT03838406

Conditions

BRCA Gene Rearrangement

Interventions

Drug	Synonyms	Arms
Chemotherapy	FOLFOX or CAPOX	BRCA1 negative

Purpose

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.

Trial Arms

Name	Type	Description	Interventions
BRCA1 positive	Experimental	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.	Chemotherapy
BRCA1 negative	Active Comparator	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.	Chemotherapy

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)

Maximum Eligible Age:	N/A
Minimum Eligible Age:	19 Years
Eligible Gender:	All
Healthy Volunteers:	No

Primary Outcome Measures

Measure:	Objective response rate
Time Frame:	through study completion, an average of 1 year
Safety Issue:
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.

Secondary Outcome Measures

Measure:	Progression free survival
Time Frame:	through study completion, an average of 1 year
Safety Issue:
Description:	the time from diagnosis to death by any cause and progression.

Measure:	Overall survival
Time Frame:	through study completion, an average of 1 year
Safety Issue:
Description:	the time from diagnosis to death by any cause

Details

Phase:	N/A
Primary Purpose:	Interventional
Overall Status:	Completed
Lead Sponsor:	Chung-Ang University

Trial Keywords

Stomach cancer
Chemotherapy
FOLFOX
Capecitabine plus Oxalipatin (CAPOX)

Last Updated

January 27, 2021

Clinical Trials /

BReast CAncer Genes(BRCA) Expressions in Metastatic Gastric Cancer