Clinical trial · Interventional
BReast CAncer Genes(BRCA) Expressions in Metastatic Gastric Cancer
A Pilot Trial of Platinum Based Chemotherapy According to BRCA Expressions as First-line Chemotherapy in Patients With Metastatic Gastric Cancer
NCT03838406CI-TRIAL-00049658completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| BRCA Gene Rearrangement | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BRCA 1 | Genetic | — | UNRESOLVED |
| Chemotherapy | Drug | Chemotherapy | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- BRCA1 positive
- description
- 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.
- interventionNames
- Genetic: BRCA 1
- Drug: Chemotherapy
- type
- ACTIVE_COMPARATOR
- label
- BRCA1 negative
- description
- 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.
- interventionNames
- Genetic: BRCA 1
- Drug: Chemotherapy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.