JPRN-jRCT1031180076进行中（未招募）3 期
JCOG1612: Single-arm confirmatory trial of the adjuvant chemoradiation for the patients with the high-risk rectal submucosal invasive cancer after the local resection - RESCUE study
SAITO Yutaka0 个研究点目标入组 210 人开始时间: 2019年1月10日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 210
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 <= 75age old（—）
- 性别
- All
入选标准
- •1) Primary tumor located at lower rectum by endoscopic finding before local resection. Local resection include endoscopic mucosal resection (EMR),endoscopic submucosal dissection (ESD),transanal local resecton, transanal endoscopic microsurgery (TEM), and minimal invasive transanal surgery (MITAS).
- •2)Within 12 weeks after local resection.
- •3)Complete resection (en bloc) was performed by local resection with either i)or ii) in pathological diagnosis.
- •i)HM0 and VM0 , or HMX and VM0 after endoscopic resection (EMR or ESD).
- •ii)(PM0, DM0, and RM0), (PMX, DM0, and RM0), (PM0, DMX, and RM0), or (PMX, DMX, and RM0) after operative local resection (transanal local resecton, TEM, or MITAS).
- •4)Pathological T1 and adenocarcinoma defined by 8th edition of Japanese Classification of Colorectal Carcinoma with fulfilled either of the following condition.
- •i)Poorly differentiated adenocarcinoma (por), or mucinous adenocarcinoma (muc), or signet-ring cell carciona (sig).
- •ii)Pathological T1b
- •iii)Lymphatic invasion positive or venous invasion positive (confirmed using immunostaining)
- •iv)Budding grade of 2-3
- •5)Confirmed as no exposure of ulcer bed (covering with regenerative epithelium) and no residual tumor by endoscopy in the primary site after locally resected.
- •6)Neither lymph node metastases nor distant metastases was confirmed by chest, abdomen, and pelvis computed tomography (cN0M0)
- •7)Age at registration is of 20 to 75 years old.
- •8)ECOG Performance status is 0 or 1.
- •9)Sufficient oral intake.
- •10)No prior rectal resection (excluding local resection) or pelvic irradiation for any malignancies
- •11)Neither hereditary bowel disease (Familial adenomatous polyposis or Lynch syndrome) nor inflammatory bowel disease (Ulcerative colitis or Crohn's disease).
- •12)Sufficient organ function.
- •i)White blood cell count >= 3,000 /mm3
- •ii)Hemoglobin >= 9.0 mg/dl
- •iii)Platelet count >= 100,000 /mm3
- •iv)T.Bil =< 2.0 mg/dL
- •v)AST =< 100 U/L
- •vi)ALT =< 100 U/L
- •vii)Cr =< 1.5 mg/dL
- •13)The surgeons explained that total mesorectal excision with D2 lymph dissection is standard therapy.
- •14)Witten informed consent is obtained.
排除标准
- •1)Synchronous or metachronous (within 5 years) malignancies except cancer with 5-year relative survival rate of 95% or more such as carcinoma in situ, intramucosal tumor, or early stage cancers.
- •2)Infections which needs systemic treatment.
- •3)Body temperature is higher than 38 degrees centigrade at registration.
- •4)Female during pregnancy, within 28 days of postparturition, or during lactation.
- •5)Severe psychological disease.
- •6)Requirement for continuous systemic corticosteroid or immunosuppressant treatment.
- •7)Uncontrollable diabetes mellitus.
- •8)Unstable angina pectoris (angina developed or attack worsened within the previous 3 weeks), or myocardial infarction within the previous 6 months.
- •9)Severe interstitial pneumonia, pulmonary fibrosis, or severe emphysema.
- •10)Requirement for phenytoin or warfarin potassium.
研究者
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