JPRN-jRCTs031220219招募中2 期
A Feasibility Study of definitive radiotherapy using 60Gy with FOLFOX for Unresectable Esophageal Cancer
Miura Akinori0 个研究点目标入组 20 人开始时间: 2022年7月20日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
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
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) Histologically diagnosed squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma by endoscopic biopsy of the primary esophageal tumor.
- •2) CT images show that the tumor is unresectable.
- •That is, one of the following applies
- •i. Wall depth of the primary tumor is T4
- •ii. Involvement of other organs via regional lymph node metastasis
- •iii. Progression after preoperative or induction chemotherapy that meets i-ii above
- •3) No distant organ metastasis on CT imaging, except for lymph node metastasis in the supraclavicular fossa if the primary lesion is in the upper chest, lymph node metastasis in either the supraclavicular fossa or periclavicular lymph nodes if the primary lesion is in the mid-thoracic region, or lymph node metastasis in the periclavicular lymph nodes if the primary lesion is in the lower chest.
- •4) Age is 18 years or older.
- •5) ECOG PS less than or equal to 2
- •6) No previous radical surgery for esophageal cancer except for endoscopic submucosal dissection
- •7) No history of radiation therapy to the chest
- •8) Meet the following laboratory requirements (latest values within 28 days prior to enrollment)
- •i. Neutrophil count more than or equal to 1,500/mm3
- •ii. Platelet count more than or equal to 100,000/mm3
- •iii. CCr more than or equal to 30ml/min/body
- •iv. Serum total bilirubin less than or equal to 3.0 mg/dL
- •v. SpO2 (room air) more than or equal to 90%
- •9) Unsuitable or unwilling to receive FP-RT as standard treatment
- •10) Written consent for participation in the study has been obtained from the patient
排除标准
- •1) Have active multiple cancers (concurrent multiple cancers and heterogeneous multiple cancers with a disease-free interval of 3 years or less). However, lesions equivalent to intraepithelial or intramucosal carcinoma that are considered curable by local treatment are not included in active multiple carcinoma.
- •2) Patients with poorly controlled diabetes mellitus.
- •3) Patients with poorly controlled hypertension
- •4) Patients with any of the following conditions requiring treatment: coronary artery disease, cardiomyopathy, heart failure, and arrhythmia.
- •5) Patients with interstitial pneumonia, pulmonary fibrosis, or severe emphysema
- •6) Patients with active infections
- •7) Pregnant or potentially pregnant women, and lactating women
- •8) Patients with concomitant psychiatric disorders or psychiatric symptoms who are judged by the pri
- •ncipal investigator or sub-investigator to be unable to participate in the study
- •9) Patients who are deemed unsuitable for participation in the study by the investigators for any other reason.
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