JPRN-jRCTs041190004进行中（未招募）2 期
Randomized phase II study comparing S-1 plus oxaliplatin with S-1 monotherapy for elderly patients with advanced gastric cancer. (WJOG8315G) - Randomized phase II study comparing S-1 plus oxaliplatin with S-1 monotherapy for elderly patients with advanced gastric cancer. (WJOG8315G)
Makiyama Akitaka0 个研究点目标入组 160 人开始时间: 2019年4月5日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 160
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 70age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) Histologically proven gastric or gastro-esophageal junction adenocarcinoma
- •2) Advanced unresectable or recurrent gastric cancer*
- •*Exclude peritoneal cytology-positive gastric cancer patients without other distant metastases
- •3) The criteria for pre-treatment
- •i. If there is no history of surgery
- •No previous chemotherapy, immunotherapy and radiation therapy for cancer. However, irradiation for the pain caused by bone metastases is allowed.
- •ii. If there is a history of surgery
- •No previous chemotherapy, immunotherapy and radiation therapy for cancer. However, irradiation for the pain caused by bone metastases is allowed.
- •a) Recurrence after radical surgery
- •Preoperative or postoperative adjuvant chemotherapy with S-1 alone is allowed.
- •More than 24 weeks (168 days) from the last date of the oral S-1 administration to recurrence
- •b) The palliative surgery for unresectable cases
- •More than two weeks after surgery
- •Postoperative complications has improved
- •Do not allow the neoadjuvant chemotherapy
- •c) Exploratory laparotomy, bypass surgery, etc. for unresectable cases.
- •4) Massive pericardial effusion, pleural effusion or ascites*.
- •*except for patients if effusions and ascites did no accumulate for more than two weeks after drainage therapy.
- •*include patients if pleurosclerosis was performed with anti-cancer drugs except OK-432.
- •5) Symptomatic brain metastases or carcinomatous meningitis.
- •6) Her2 negative+
- •*HER2 IHC 0, 1+, or IHC 2+ and FISH negative
- •7) Measurable or evaluable lesion*
- •*Distant metastasis difficult to point out with CT, such as peritoneal dissemination which can be pointed out only by laparoscopic examination, is not regarded as an evaluable lesion. In this case, however, it shall be qualified if it has a primary tumor or a regional lymph node metastasis that can be evaluated by CT.
- •8) Adequate oral intake and able to take oral medication
- •9) 70 years old or older
- •10) ECOG performance status 0-2.
- •11) Adequate bone marrow and organ function as defined as below:
- •neutrophil count >=1500/mm3
- •hemoglobin level >= 8.0 g/dL
- •platelet count >= 100,000/mm3
- •AST and ALT <= 100 IU/L, or AST and ALT <=200 IU/L with liver metastases
- •total bilirubin <= 1.5 mg/dL
- •serum creatinine <=1.5 mg/dL
- •creatinine clearance >=30mL/min
- •*Estimate by Cockcroft-Gault formula.
- •An actual measurement is not prioritized.
- •Male: Ccr = ((140-age) x weight(kg)) / (72 x serum Cr value (mg/dL))
- •Female: Ccr = 0.85 x ((140-age) x weight(kg)) / (72 x serum Cr value (mg/dL))
- •12) Written informed consent
排除标准
- •1) Synchronous or metachronous (within 5 years) malignancies other than carcinoma in situ or mucosal carcinoma.
- •2) Active infection under treatment
- •3) Peripheral sensory neuropathy of grade >= 2 according to NCI-CTCAE version 4.0.
- •4) Diarrhea of grade >= 2 according to NCI-CTCAE version 4.0.
- •5) Pulmonary fibrosis or interstitial pneumonitis detected by chest x-ray.
- •6) Receiving flucytosine
- •7) Receiving phenytoin or warfarin potassium
- •8) Current treatment with corticosteroids.
- •9) Pregnant or lactating female.
- •10) Uncontrolled psychiatry disease
- •11) History of serious allergic reactions.
- •12) Evidence of any other serious disease, e.g. COPD, uncontrolled diabetes mellitus, uncontrolled hypertension, uncontrolled cardiovascular disease, Cerebral infarction within one year, active gastrointestinal hemorrhage, blood tests positive for HBs antigen or HVC antibody.
- •13) Judged inappropriate by the investigators.
研究者
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