JPRN-jRCTs051180012已完成1 期
Phase I/II trial of combined chemotherapy of Nab-paclitaxel, S-1, and Oxaliplatin for gastric cancer patients with peritoneal metastasis (NSOX study) - NSOX study
akamura Masaki0 个研究点目标入组 6 人开始时间: 2018年12月4日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6
研究概览
简要总结
The NSOX regimen was shown to be a tolerable regimen and may be a promising triplet therapy for patients with gastric cancer with peritoneal metastasis.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 75age old（—）
- 性别
- All
入选标准
- •1. Histologically proven adenocarcinoma of gastric cancer and positive peritoneal dissemination by staging laparoscopy (except recurrent gastric cancer )
- •2. HER2 negative (or untested)
- •3. No non-curative factors except for peritoneal dissemination
- •4. No prior chemotherapy or radiation therapy (in case of previous adjuvant therapy, interval between end of chemotherapy and relapse must be > 6 months for S-1 therapy)
- •5. Age 20-75 years
- •6. ECOG PS 0 or 1
- •7. Able to ingest
- •8. Patients must have normal organ and marrow function as defined below within 14 days prior to enrollment :
- •Neutrophils (ANC) >= 1,500 /mm3
- •Platelets >=100,000 /mm3
- •Hemoglobin >= 8g/dL
- •Serum bilirubin <= 2.0 x upper normal limit (ULN)
- •AST/ALT <= 100 U/L
- •Serum creatinine level <= 1.2 mg/dL
- •CCR >= 60 mL/min
- •9. Life expectancy of at least 3 months
- •10.Signed and dated informed consent
排除标准
- •1. History of hypersensitivity to nab-paclitaxel, S-1 or oxaliplatin
- •2. Contraindication for nab-paclitaxel, S-1 or oxaliplatin
- •(e.g. cases receiving severe bone marrow function suppression, severe renal disorder, severe liver disorder, administration of other pyrimidine-based antitumor agents, fluoride or flucytosine)
- •3. Active infectious disease
- •4. HBs-antigen positive
- •5. Severe complications, such as those listed below:
- •Uncontrolled heart failure/unstable angina pectoris/cardiac arrhythmia
- •Myocardial infarction (< 3 months prior to study entry)
- •Uncontrolled diabetes mellitus, uncontrolled hypertension
- •Interstitial pneumonia, pulmonary fibrosis
- •Complications that present serious obstacles to this study
- •6. Symptomatic neuropathy
- •7. Known brain metastasis with clinical symptoms
- •(if asymptomatic, examination is not required)
- •8. Watery diarrhea.
- •9. Active double cancer.
- •Synchronous or metachronous(within 5 years) malignancies except for carcinoma in situ or intramucosal tumors curatively treated with local therapy
- •10. Breast-feeding, pregnant or planning pregnancy
- •11. Patients who are otherwise judged to be ineligible for enrolment by investigators
研究者
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