jRCT1051250221招募中不适用
A randomized controlled phase II trial of induction treatment for Japanese patients with cT4 esophageal cancer (IT-T4EC)
未提供0 个研究点目标入组 102 人开始时间: 待定
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 102
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
入排标准
- 年龄范围
- 18age old over 至 80age old not（—）
- 性别
- All
入选标准
- •Primary cases of thoracic esophageal cancer diagnosed histologically as squamous cell carcinoma (including adenocarcinoma with squamous differentiation and basaloid carcinoma), including cases partially involving the cervical or abdominal esophagus.
- •Unresectable thoracic esophageal cancer clinically demonstrating adjacent organ invasion (cT4) without distant organ metastasis. Positive abdominal lymph nodes (No. 1, 2, 3, 7, 9) and supraclavicular lymph nodes (No. 10-4) are eligible, but cases meeting the following conditions are excluded:
- •Primary lesion in upper thoracic region (Ut): Positive abdominal lymph node metastasis
- •Primary lesion in the middle thoracic region (Mt): Positive metastasis in both supraclavicular and abdominal lymph nodes
- •Primary lesion in the lower thoracic region (Lt): Positive metastasis in both supraclavicular and abdominal lymph nodes
- •Patient aged at registration is 18 years or older and less than 80 years.
- •Patient with ECOG Performance status (PS) 0 or
- •Patient without prior drug therapy (endocrine therapy, chemotherapy, molecular targeted therapy, immunotherapy) within the past 5 years, including treatment for other cancer types.
- •Patient without prior radiation therapy to the neck or chest, including treatment for other cancer types.
- •Patient without prior treatment for esophageal cancer. However, endoscopic resection achieving curative resection (pT1a, ly0, v0) is acceptable.
- •The most recent laboratory values obtained within 14 days prior to registration (values from the same day of the week 2 weeks prior to the registration date are acceptable) meet all of the following criteria:
- •(1) White blood cell count >= 3000/mm3 and < 12000/mm3
- •(2) Neutrophil count >= 1500/mm3
- •(3) Hemoglobin >= 8.0 g/dL (No blood transfusion within 14 days prior to the blood draw date for the test used for registration)
- •(4) Platelet count >= 10 x 10000/mm3
- •(5) Total bilirubin <= 1.5 mg/dL
- •(6) AST <= 100 U/L
- •(7) ALT <= 100 U/L
- •(8) Creatinine clearance >= 50 mL/min
- •Estimated value using the Cockcroft-Gault formula must be >= 50 mL/min/body. If the estimated value is < 50 mL/min/body, eligibility is confirmed if the actual measured value is >= 50 mL/min/body.
- •(9) SpO2 >= 95% (room air)
- •Patient from whom written consent for trial participation can be obtained.
排除标准
- •Active concurrent cancers (synchronous multiple cancers and metachronous multiple cancers with a disease-free interval of 5 years or less). However, even if the disease-free period is less than 5 years, a history of cancer with a 5-year relative survival rate of 95% or higher, such as clinical stage I prostate cancer, clinical stage 0 or I laryngeal cancer with complete response to radiation therapy, or completely resected cancer of the following pathological stages, is not included in active concurrent/multiple cancers).
- •Gastric cancer "adenocarcinoma (general type)": Stage 0-I, colon cancer (adenocarcinoma): Stage 0-I, rectal cancer (adenocarcinoma): Stage 0-I, esophageal cancer (squamous cell carcinoma, adenocarcinoma with squamous differentiation, basaloid carcinoma): Stage 0, breast cancer (ductal carcinoma in situ, lobular carcinoma in situ): Stage 0, Breast cancer (invasive ductal carcinoma, invasive lobular carcinoma, Paget's disease): Stage 0-IIA, Endometrial cancer (endometrioid adenocarcinoma, mucinous adenocarcinoma): Stage I, Prostate cancer (adenocarcinoma): Stage I-II, Cervical carcinoma (squamous cell carcinoma): Stage 0, Thyroid carcinoma (papillary carcinoma, follicular carcinoma): Stage I, II, III, Renal carcinoma (clear cell carcinoma, chromophobe carcinoma): Stage I, Other mucosal carcinoma-equivalent lesions
- •Staging follows UICC-TNM 8th Edition or equivalent cancer classification systems as a general rule
- •Patient with an infection requiring systemic treatment.
- •Patient with fever of 38.0 C (100.4 F) or higher at registration.
- •Women who are pregnant, may be pregnant, within 28 days postpartum, or breastfeeding. Men whose partners wish to become pregnant.
- •Patient with a psychiatric disorder or psychiatric symptoms that interfere with daily life, making participation in the trial difficult.
- •Patient receiving continuous systemic administration (oral or intravenous) of steroids or other immunosuppressive drugs.
- •Patient requiring continuous use of one or more of the following: flucytosine, phenytoin, or warfarin potassium.
- •Patient with comorbid unstable angina (angina that has developed or worsened within the last 3 weeks) or a history of myocardial infarction within the last 6 months.
- •Patient with poorly controlled valvular heart disease, dilated cardiomyopathy, or hypertrophic cardiomyopathy.
- •Patient with poorly controlled hypertension.
- •Patient with poorly controlled diabetes mellitus.
- •Patient complicated by one or more of the following diagnosed by chest CT: interstitial pneumonia, pulmonary fibrosis, or severe emphysema.
- •Patient deemed unsuitable as study subjects by the investigator for other reasons.
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