A Pilot Trial of Platinum Based Chemotherapy According to BRCA Expressions as First-line Chemotherapy in Patients With Metastatic Gastric Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Objective response rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
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.
干预措施: BRCA 1 (Genetic)
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.
干预措施: Chemotherapy (Drug)
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.
干预措施: BRCA 1 (Genetic)
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.
干预措施: Chemotherapy (Drug)
结局指标
主要结局
Objective response rate
时间窗: 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.
次要结局
- Progression free survival(through study completion, an average of 1 year)
- Overall survival(through study completion, an average of 1 year)
研究者
In Gyu Hwang
Associate Professor
Chung-Ang University