JPRN-jRCTs041180146已完成3 期
A Phase III Study of Docetaxel plus S-1 versus S-1 Alone in the Treatment of Curatively Resected Stage III Gastric Cancer(JACCRO GC-07(START-2))
KODERA Yasuhiro0 个研究点目标入组 951 人开始时间: 2019年3月29日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 951
研究概览
简要总结
Postoperative adjuvant therapy with S-1 plus docetaxel was confirmed to improve both RFS and OS and can be recommended as a standard of care for patients with stage III gastric cancer treated by D2 dissection.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 80age old（—）
- 性别
- All
入选标准
- •(1) Patients with a histologically confirmed common type of gastric cancer in pathologic stage IIIA, IIIB, or IIIC
- •(2) Patients who underwent R0 surgery (i.e., no residual tumor) with D2 lymphadenectomy. However, patients who underwent total gastrectomy without splenectomy (without No. 10 lymph node dissection) will also be eligible.
- •(3) Patients without any hepatic, peritoneal, or distant metastasis, with negative peritoneal lavage cytology
- •(4) Patients aged between >=20 years and <=80 years at the time of enrollment
- •(5) Patients with an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score 0 or 1
- •(6) Patients who underwent surgery for the primary disease within the past 6 weeks (i.e., within 42 postoperative days, with the day of surgery defined as postoperative day 0) and who can take oral medication
- •(7) Patients without any prior nonsurgical therapy (such as radiotherapy or chemotherapy) for the primary disease
- •(8) Patients with adequately maintained major organ functions meeting the following criteria based on laboratory tests within 14 days before enrollment
- •(9) Patients who personally provided written consent to participate in the study
排除标准
- •(1) Patients with synchronous or metachronous multiple primary cancers
- •(2) Patients with serious postoperative complications (e.g., serious postoperative infection, anastomotic leakage, gastrointestinal hemorrhage)
- •(3) Patients with serious concurrent diseases (e.g., intestinal paralysis, intestinal obstruction, interstitial pneumonia or pulmonary fibrosis, uncontrolled diabetes mellitus, uncontrolled hypertension, cardiac failure, renal failure, hepatic cirrhosis, hepatic failure)
- •(4) Patients with active infection
- •(5) Patients positive for HBs antigen or HCV antibody
- •(6) Patients receiving chronic systemic (oral or intravenous) steroid therapy
- •(7) Patients with diarrhea (watery stools)
- •(8) Patients with serious drug allergy
- •(9) Patients in whom both iodinated agents and gadolinium-based agents cannot be used because of drug allergy
- •(10) Patients on oral flucytosine
- •(11) Patients requiring oral warfarin potassium
- •(12) Pregnant women or women with possible pregnancy, or men who desire pregnancy of their partner
- •(13) Other patients judged by the investigator or subinvestigator to be inappropriate for participation in this this study
研究者
相似试验
已完成
不适用
A Phase III Study of Docetaxel plus S-1 versus S-1 Alone in the Treatment of Curatively Resected Stage III Gastric CancerGastric CancerJPRN-UMIN000010337Japan Clinical Cancer Reseach Organization (JACCRO)1,100
已完成
3 期
East Asian S-1 Trial(EAST) - Lung Cancer(LC).ocally advanced or metastatic NSCLC (clinical stage IIIB or IV) for which curative radiotherapy is not indicated.JPRN-jRCT1080221121Taiho Pharmaceutical Co., Ltd.1,154
已完成
3 期
A Phase III Study of Docetaxel and S-1 versus S-1 in the Treatment of Advanced Gastric CancerGastric CancerJPRN-C000000251Japan Clinical Cancer Research Organization628
已完成
2 期
Phase II Study of Docetaxel and S-1 Combination Therapy for Advanced or Recurrent Gastric CancerMetastatic gastric cancer (Advanced or recurrent gastric cancer)JPRN-C000000103Hiroshima Cancer Therapy Development Organization (HiCTDO)50
Unknown
2 期
Study Comparing Sequential Therapy of S1+Docetaxel Followed by S1 to Concomitant S1+Docetaxel for Advanced Gastric CancerGastric CancerNCT01718626Hebei Tumor Hospital100