JCOG1904: A randomized controlled phase III trial of comparing local field with additional prophylactic irradiation in chemoradiotherapy for clinical-T1bN0M0 esophageal cancer - ARMADILLO

TSUSHIMA Takahiro0 个研究点目标入组 176 人开始时间: 2020年7月14日最近更新: 2024年1月22日

适应症

试验速览

暂无简介。

•(1)Histologically proven squamous cell carcinoma, adenosquamous carcinoma, or basaloid cell carcinoma.
•(2)All lesions located in the thoracic esophagus. Secondary lesions with absolute indication for endoscopic resection (EMR/ESD) may not be confined to the thoracic esophagus.
•(3)Clinical N0M0 with cervical to abdominal contrast-enhanced CT.
•(4)The deepest lesion is diagnosed as cT1b (SM1 / SM2 / SM3) with upper gastrointestinal endoscopy. If it is difficult to differentiate cT1a-MM and cT1b-SM1 clinically, the wall depth is diagnosed as cT1b-SM1.
•(5)Aged 20 years and older.
•(6)ECOG Performance status 0 or 1.
•(7)No previous therapy against esophageal cancer except for complete resection by EMR/ESD with either pT1a-LPM(pM2)/pT1a-MM(M3) disease or pT1a-MM(M3) disease without vascular infiltration.
•(8)No history of radiotherapy for the neck, chest, and upper abdomen for any cancers. No chemotherapy or hormone therapy with less than 3 years of disease-free interval for any cancers.
•(9)Major organ function is preserved.
•1) WBC<=12,000/mm3
•2) ANC>=1,500/mm3
•3) Hb>=10.0 g/dL
•4) PLT>=10,000/mm3,
•5) T-bil<=1.5 mg/dL,
•6) AST<=100 IU/L,
•7) ALT<=100 IU/L
•8) SpO2>=95%
•9) Ccr>=60 mL/min,
•(10)Patients do not have a preference to receive a surgical resection as an initial therapy after receiving explanations.
•(11)Witten informed consent is obtained.

•(1)Simultaneous or metachronous (within 5 years) double cancers , with the exception of intramucosal tumor curable with local therapy.
•(2)Active infection requiring systemic therapy.
•(3)Fever over 38 degrees Celsius
•(4)Female during pregnancy, within 28 days of postparturition, or during lactation. Male who wants partner's pregnancy.
•(5)Psychological disorder difficult to participate in this clinical study.
•(6)Receiving continuous systemic corticosteroid or immunosuppressant treatment.
•(7)Positive for HBs antigen or HIV antigen.
•(8)Diabetes mellitus uncontrollable with continuous use of insuline or hypoglycemic agents.
•(9)Uncontrolled arterial hypertension.
•(10)History of unstable angina pectoris within three weeks or myocardial infarction within six months before registration.
•(11)Uncontrolled valvular disease, dilated cardiomyopathy, and hypertrophic cardiomyopathy.
•(12)Severe emphysema, interstitial pneumonia or pulmonary fibrosis based on chest CT.
•(13)With a history of cerebrovascular disorder within 6 months.
•(14)Drug allergy for iodic drug.

发起方

TSUSHIMA Takahiro