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BReast CAncer Genes(BRCA) Expressions in Metastatic Gastric Cancer

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ClinicalTrials.gov Identifier: NCT03838406
Recruitment Status : Recruiting
First Posted : February 12, 2019
Last Update Posted : February 12, 2019
Sponsor:
Information provided by (Responsible Party):
In Gyu Hwang, Chung-Ang University

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.

Condition or disease Intervention/treatment Phase
BRCA Gene Rearrangement Genetic: BRCA 1 Drug: Chemotherapy Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Trial of Platinum Based Chemotherapy According to BRCA Expressions as First-line Chemotherapy in Patients With Metastatic Gastric Cancer
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.

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.

Other Name: FOLFOX or CAPOX

Active Comparator: 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.

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.

Other Name: FOLFOX or CAPOX




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03838406


Contacts
Contact: Song Ee Park 82-2-6299-3185 putoto@naver.com
Contact: In Gyu Hwang 82-2-6299-1403 hematoonco@naver.com

Locations
Korea, Republic of
Chung-Ang University College of Medicine Recruiting
Seoul, Korea, Republic of, 06973
Contact: Song Ee Park    82-2-6299-3185    putoto@naver.com   
Sponsors and Collaborators
Chung-Ang University
Investigators
Principal Investigator: In Gyu Hwang Chung-Ang University Hosptial, Chung-Ang University College of Medicine

Responsible Party: In Gyu Hwang, Associate Professor, Chung-Ang University
ClinicalTrials.gov Identifier: NCT03838406     History of Changes
Other Study ID Numbers: 1771-001-287
First Posted: February 12, 2019    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by In Gyu Hwang, Chung-Ang University:
Stomach cancer
Chemotherapy
FOLFOX
Capecitabine plus Oxalipatin (CAPOX)

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Capecitabine
Oxaliplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents