NCT03223740Unknown3 期
A Phase III Trial of Preoperative or Postoperative Chemoradiation Therapy for Potentially Resectable Adenocarcinoma of Stomach Cancer
Sichuan Provincial People's Hospital3 个研究点 分布在 1 个国家目标入组 450 人开始时间: 2016年9月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 450
- 试验地点
- 3
- 主要终点
- Progression Free Survival
研究概览
简要总结
Based upon RTOG 9904, this study is to investigate the role of preoperative chemo and chemoradiation for locally advanced gastric cancer.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with potentially resectable adenocarcinoma of the stomach with histologic proof.
- •EUS or MRI stage T3-4, any N, M
- •Adequate bone marrow (defined as peripheral absolute granulocyte count of > 2,000/μL, and platelet count of>100,000/μL), liver (bilirubin < 1.5 mg/dl), and renal functions (creatinine < 1.5 mg/dl).
- •Absence of peritoneal disease by laparoscopic staging; no positive cytology of pleural, or pericardial effusion.
- •No prior major surgery or radiotherapy to the stomach, or immunotherapy or chemotherapy for any reason.
- •Patients must have a life expectancy of at least 16 weeks.
- •Performance status of < 2 (Zubrod scale).
- •No biopsy proof of lymph node metastases outside the study field.
- •No evidence of metastatic disease to distant organs.
- •No presence of concurrent or previous malignancies < 5 years, other than noninvasive skin cancer.
- •No uncontrolled or severe cardiac disease, diabetes or hypertension.
- •Signed study-specific consent form prior to study entry.
排除标准
- •Evidence of metastatic disease
- •Prior chemotherapy or radiotherapy
- •Patients with a past history of cancer
- •Patients with other significant underlying medical conditions that may be aggravated by the study treatment or are not controlled
- •Pregnant or lactating females or female patients of childbearing potential who have not been surgically sterilized or are without adequate contraceptive measures
- •Cardiac failure or Sever Pulmonary disease
- •Patients with impaired gastrointestinal absorption for whatever reason
- •Patients medically unfit for cisplatin or taxol chemotherapy
研究组 & 干预措施
Arm 1 pre-operative chemoradiation
Experimental
Chemo1 x 2 followed by ChemRT followed by Surgery followed by Chemo2 x 2
干预措施: Arm 1 pre-operative chemoradiation (Other)
Arm 2 post operative chemoradiation
Active Comparator
Surgery followed by Chemo1 x 2 followed by ChemRT followed by Chemo2 x 2
干预措施: Arm 2 post operative chemoradiation (Other)
结局指标
主要结局
Progression Free Survival
时间窗: up to 5 year
次要结局
- R0 Resection Rate(At time of surgery)
- Overall Survival(up to 5 year)
研究者
ming zeng, MD
Director of Cancer Center
Sichuan Provincial People's Hospital
研究点 (3)
Loading locations...
相似试验
已完成
不适用
Quality of Life in Neoadjuvant Versus Adjuvant Therapy of Esophageal Cancer Treatment TrialEsophageal NeoplasmsNCT00907543Richard Malthaner96
已完成
1 期
Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With Locally Advanced Rectal CancerAdenocarcinoma of the RectumMucinous Adenocarcinoma of the RectumSignet Ring Adenocarcinoma of the RectumStage IIA Rectal CancerStage IIB Rectal CancerStage IIC Rectal CancerStage IIIA Rectal CancerStage IIIB Rectal CancerStage IIIC Rectal CancerNCT00003799National Cancer Institute (NCI)20
已完成
2 期
Trial of Pre-operative Chemoradiotherapy Followed by Surgical Resection in Pancoast Tumors (JCOG 9806)Pulmonary NeoplasmNCT00128037Japan Clinical Oncology Group75
撤回
3 期
Chemotherapy Before & After Surgery in Patients With Resectable Gallbladder CancerStage I Gallbladder Cancer AJCC v8Stage II Gallbladder Cancer AJCC v8Stage IIA Gallbladder Cancer AJCC v8Stage IIB Gallbladder Cancer AJCC v8Stage III Gallbladder Cancer AJCC v8Stage IIIA Gallbladder Cancer AJCC v8Stage IIIB Gallbladder Cancer AJCC v8NCT03579758Emory University
进行中（未招募）
3 期
Clinical Trial of Neoadjuvant Chemotherapy With Atezolizumab or Placebo in Patients With Triple-Negative Breast Cancer Followed After Surgery by Atezolizumab or PlaceboTriple Negative Breast CancerNCT03281954NSABP Foundation Inc1,550