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Completed

NCT Number: NCT03838406

BReast CAncer Genes(BRCA) Expressions in Metastatic Gastric Cancer

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.

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Key information

Conditions

BRCA Gene Rearrangement Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chung-Ang University College of Medicine

Seoul, 06973, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

BRCA 1

Genetic

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

Chemotherapy

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.

Other names: FOLFOX or CAPOX

Primary outcomes

  1. Objective response rate

    Time frame: through study completion, an average of 1 year

    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 outcomes

  1. Progression free survival

    Time frame: through study completion, an average of 1 year

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

  2. Overall survival

    Time frame: through study completion, an average of 1 year

    the time from diagnosis to death by any cause

Sponsors and collaborators

Lead sponsor

Chung-Ang University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Feb 12, 2019
Registry last updated
Jan 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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