JPRN-jRCT1030220248招募中3 期
JCOG2013: A multicenter randomized controlled trial of esophagectomy with or without prophylactic supraclavicular node dissection: a phase 3 trial - MODERN 3
Tsubosa Yasuhiro0 个研究点目标入组 480 人开始时间: 2022年8月7日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 480
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
- >= 20age old 至 <= 80age old（—）
- 性别
- All
入选标准
- •(1) Histologically proven squamous cell carcinoma, adenosquamous carcinoma, or basaloid cell carcinoma.
- •(2) Primary tumor located in the upper thoracic or the mid-thoracic portion of the esophagus and all lesions located in the thoracic esophagus.
- •(3) Multiple tumors are eligible. Secondary lesion in the cervical esophagus which is indicated for endoscopic resection (EMR/ESD) is eligible.
- •(4) Clinical Stage I, II, III, or IVA (except for T4) based on the cervical to abdominal contrast-enhanced CT (UICC-TNM 8th edition). In case patients have undergone neoadjuvant chemotherapy (DCF based on JCOG1109 or CF based on JCOG9907), they are eligible if only pretreatment stages are I, II, III, or IVA (except for T4) and currently there is no evidence of T4 nor adjacent organ involvement from metastatic lymph nodes.
- •(5) Aged 18 to 80 years old.
- •(6) ECOG Performance status 0 or 1.
- •(7) Fit for one-stage right-thoracoabdominal esophagectomy including minimally invasive procedure (thoracoscopy, laparoscopy, and robot-assisted) to accomplish R0 resection.
- •(8) No prior chemotherapy, radiotherapy, and immunotherapy for any other cancers. Hormone therapy for breast cancer or prostate cancer is eligible.
- •(9) No previous anterior neck surgery. No previous surgery for right lung cancer.
- •(10) No previous treatment for esophageal cancer except for the followings;
- •1. Non-curative resection for the primary tumor by EMR/ESD.
- •2. Neoadjuvant chemotherapy defined in (4).
- •3. Complete resection by EMR/ESD for asynchronous multiple lesion.
- •(11) Major organ function is preserved.
- •1. WBC>=3,000/mm3
- •2. PLT>=100,000/mm3
- •3. T-bil<=1.5 mg/dL
- •4. AST<=100 IU/L
- •5. ALT<=100 IU/L
- •6. Creatinine of<= 1.5 mg/dL
- •7. SpO2>=95% (room air)
- •(12) Written informed consent
排除标准
- •(1) Synchronous or metachronous (within 5 years) malignancies.
- •(2) Infectious disease requiring systemic treatment.
- •(3) Body temperature of 38 degrees Celsius or higher.
- •(4) Female during pregnancy, within 28 days of postparturition, or during lactation.
- •(5) Psychological disorder difficult to participate in this clinical study.
- •(6) Receiving continuous systemic corticosteroid or immunosuppressant treatment.
- •(7) Poorly controlled diabetes mellitus even with continuous use of insuline or hypoglycemic agents.
- •(8) Uncontrolled arterial hypertension.
- •(9) History of unstable angina pectoris within three weeks or myocardial infarction within six months before registration.
- •(10) Uncontrolled valvular disease, dilated cardiomyopathy, and hypertrophic cardiomyopathy.
- •(11) Severe emphysema, interstitial pneumonia or pulmonary fibrosis based on chest CT.
研究者
相似试验
进行中（未招募）
3 期
JCOG1308C: A multicenter randomized phase III study for recurrent glioblastomaGlioblastoma at the first relapse or progressionJPRN-jRCTs031180083AGANE Motoo146
进行中（未招募）
3 期
JCOG1703: A multicenter randomized phase III study for newly-diagnosed maximally resected glioblastoma comparing Carmustine wafer implantation followed by chemoradiotherapy with temozolomide with chemoradiotherapy aloneglioblastomaJPRN-jRCT1031190035KUMABE Toshihiro250
进行中（未招募）
3 期
JCOG2007: A Multicenter Randomized Phase III Study comparing Pembrolizumab + Platinum Combination Chemotherapy with Nivolumab + Ipilimumab + Platinum Combination Chemotherapy for Treatment-naive Advanced Non-Small Cell Lung Cancer without Driver Gene alteratioTreatment-naive advanced non-small cell lung cancer without driver gene alterationNSCLC, advanced, driver oncogene negativeD002289JPRN-jRCTs031210013OKAMOTO Isamu422
尚未招募
3 期
Phase III Trial of R21/Matrix-MMalariaPACTR202102694561794niversity of Oxford4,800
已完成
3 期
A randomized controlled multicenter phase III trial comparing cytoreductive surgery followed by intravenous chemotherapy versus intravenous chemotherapy alone for recurrent platinum-sensitive ovarian cancercancer of the ovaries1003859410029903ovarian cancerNL-OMON35952niversitair Medisch Centrum Sint Radboud230