NCT07603375招募中2 期
A Single-arm Study of Upfront Chemotherapy With Radiation Therapy (CRT) Followed by Chemotherapy in Localized Esophageal Adenocarcinoma
Duke University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年9月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Number of participants with Clinical complete response (cCR)
研究概览
简要总结
The goal of this trial is to learn if adding consolidative chemotherapy to routine chemoradiation can better control both local recurrence and metastasis and reduce the need for surgical intervention.
研究设计
- 研究类型
- 干预性
- 分配方式
- 不适用
- 干预模型
- 单组
- 主要目的
- 治疗
- 盲法
- 开放（无盲法）
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- Subject must be able to provide study specific informed consent prior to study entry
- Must be newly diagnosed, histologically proven diagnosis of adenocarcinoma of the thoracic esophagus or gastroesophageal junction (Siewert I-II);
- Stage II-IVA, excluding T4b, according to the American Joint Committee on Cancer (AJCC) 8th edition;
- Complete history and physical examination within 21 days of signing consent;
- Staging whole-body FDG-PET/CT (fluorodeoxyglucose-positron emission tomography/computed tomography) scan with or without contrast (preferred) or chest/abdominal (CT with contrast) confirming there is no evidence of metastatic disease must be obtained within 45 days of study enrollment
- ECOG (Eastern Cooperative Oncology Group) performance status of 0-2
- Subjects must be appropriate candidates for planned chemoradiation (concurrent carboplatin/paclitaxel) and chemotherapy (FLOT, m-FOLFOX-6) as determined by the treating radiation oncologist, medical oncologist, and surgical oncologist.
- Adequate hematologic, renal, and hepatic function within 14 days of initiation of therapy
排除标准
- Cervical esophageal cancers arising 15-18 cm from the incisors.
- Esophageal squamous cell carcinoma.
- Patients with T4b disease according to the AJCC 8th Edition.
- Definitive clinical or radiologic evidence of metastatic disease.
- Has had prior systemic therapy or radiation therapy for the current diagnosis.
- Prior thoracic radiotherapy for any reason that would result in overlap of radiation therapy fields; all patients with prior radiotherapy must be reviewed by the PI to determine if patient is eligible.
- Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer
- Severe, active co-morbidity defined as follows:
- Active uncontrolled infection requiring IV antibiotics;
- Pregnant and/or nursing subjects;
- HIV positive with CD4 count < 200 cells/microliter. Note that subjects who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count ≥ 200 cells/microliter within 30 days prior to registration. Note also that HIV testing is not required for eligibility for this protocol. This exclusion criterion is necessary because the treatments involved in this protocol may be significantly immunosuppressive.
- Has a history or current evidence of physical or physiological contraindication to participation in this study, at the discretion of the treating investigator.
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
研究组 & 干预措施
Chemoradiation with consolidative chemotherapy
Experimental
Participants will receive a standard course of chemoradiation followed by consolidative chemotherapy (FOLFOX regimen at the treating physician's discretion).
干预措施: FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin) (Drug)
结局指标
主要结局
Number of participants with Clinical complete response (cCR)
时间窗: approximately 36 weeks
cCR defined as absence of malignancy on endoscopic biopsies obtained at the time of reassessment following neoadjuvant therapy
次要结局
- Number of participants with pathologic complete response (pCR)(approximately 36 weeks)
- Number of participants who complete both chemoradiation and chemotherapy(approximately 36 weeks)
- Number of participants with local control(up to 5 years)
- Number of participants with Disease free survival(up to 5 years)
- Time to distant metastasis(up to 5 years)
- Overall survival(up to 5 years)
- Number of participants with Local control(up to 5 years)
- Disease free survival(up to 5 years)
研究者
研究点 (2)
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标识符
- NCT 编号
- NCT07603375
- 其他研究编号
- Pro00120182
日期
- 首次提交
- (4个月前)
- 首次发布
- (4个月前)
- 主要完成日期
- (2年后)
- 研究完成日期
- (7年后)
- 最近核实
- (29天前)
- 最近更新
- (昨天)
监管与共享
- FDA 监管药物
- 是
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 否
- 是否有结果
- 否
Data may be shared 6 months after publication or as required by the journal
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