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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BRCA 1 | Genetic | The investigators evaluated the incidence of BRCA loss in patients with advanced gastric cancer and observed the treatment outcome and prognosis. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival | the time from diagnosis to death by any cause and progression. | through study completion, an average of 1 year |
| Overall survival | the time from diagnosis to death by any cause |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| In Gyu Hwang | Chung-Ang University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chung-Ang University College of Medicine | Seoul | 06973 | South Korea |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| C410216 | Folfox protocol |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| 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. |
|
|
| through study completion, an average of 1 year |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |