NCT03000816已完成不适用
A Phase 2 Study of Stereotactic Body Radiotherapy (SBRT) for the Treatment of OligoMetastatic Esophageal Squamous Cell Carcinoma
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
The aim of this phase II trial is to assess progress-free survival, local control, overall survival, safety and tolerability of SBRT to treat patients with oligometastases in esophageal squamous cell carcinoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients with metastatic esophageal squamous cell carcinoma who have received initial treatment for the primary site including surgery or chemoradiotherapy. Primary tumor site without progression at registration. The sites of allowed metastases are: peripheral lung, central lung, medistinal/cervical lymph node, liver, spinal/paraspinal, osseous, and abdominal-pelvic lymph node. All metastases not resected must be amenable to SBRT.
- •1-4 radiographically distinct metastases of any distribution in 2 or less allowed anatomical sites. The diameters of lesions should be less than or equal to 5cm.
- •Initial treatment should be completed at least 3 months prior to study registration.
- •All the metastases treated with SBRT should not be treated with surgery, radiation, radio frequency ablation or other regional therapeutic modalities prior to study registration. The other (s) lesions should have been surgically removed.
- •PS ECOG 0-2，wight loss<30% during the latest 6 months.
- •Evaluation by a radiation oncologist that the patient could tolerate the treatment of SBRT.
- •Patient must provide study specific informed consent prior to study entry.
- •For females of child-bearing potential, negative serum/urine pregnancy test within 14 days prior to study registration.
排除标准
- •Progression of primary tumor site at time of registration.
- •Metastases with indistinct borders making targeting not feasible.
- •Known brain metastases.
- •Prior palliative radiotherapy to metastases.
- •Metastases located within 3 cm of the previously irradiated structures:
- •a).Spinal cord previously irradiated >80Gy(Biological equivalent dose with α/β=2), b).Brachial plexus previously irradiated to > 100Gy(Biological equivalent dose with α/β=2), c).Small intestine, large intestine, or stomach previously irradiated to > 90Gy (Biological equivalent dose with α/β=2), d).Whole lung previously irradiated with prior V20Gy > 30% (delivered in ≤ 3 Gy/fraction), e)Metastasis irradiated with SBRT.
- •Pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives.
- •Drug addiction,Alcoholism or AIDS.
- •Patients with severe organ dysfunction or Acute bacterial or fungal infection who are considered not suitable to enroll the study at the time of registration.
结局指标
主要结局
Progression-free survival
时间窗: The survival time from the date each patient enrolled to the date of progression or date of death from any cause, whichever came first, assessed up to 5 years
progression-free survival will be measured as time to either progression or death
次要结局
- Local control(the time from the date each patient enrolled to the date of local failure or the last follow-up, assessed up to 5 years.)
- overall survival(The survival time from the date each patient enrolled to the date of death or the last follow-up, assessed up to 5 years.)
研究者
Kuai Le Zhao, MD
Professor
Fudan University
研究点 (1)
Loading locations...
相似试验
招募中
2 期
Trial Of Stereotactic Body Radiation Therapy (SBRT) for Oligoprogression on Immune Checkpoint Inhibitors (ICI) in Metastatic Renal Cell CarcinomaMetastatic Renal Cell CarcinomaOligoprogressiveProgressionRenal Cell CarcinomaNCT04974671Yale University30
终止
2 期
Phase II SBRT & Chemo for Unresectable Cholangiocarcinoma Followed by Liver TransplantationHepatobiliary NeoplasmBile Duct CancerCancer of GallbladderLiver CancerCholangiocarcinomaNCT01151761Stanford University2
招募中
2 期
Phase 2 Study of SBRT Plus Tislelizumab and Regorafenib in Unresectable or Oligometastatic HCCUnresectable Hepatocellular CarcinomaOligometastatic DiseaseNCT05917431Peking University Cancer Hospital & Institute39
已完成
不适用
Radiotherapy for Oligometastatic Prostate CancerOligometastatic Prostate CancerNCT01859221University of Florida39
终止
1 期
Stereotactic Body Radiation Therapy and Durvalumab With or Without Tremelimumab Before Surgery in Treating Participants With Human Papillomavirus Positive Oropharyngeal Squamous Cell CanerClinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC (American Joint Committee on Cancer) v8Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Human Papillomavirus PositiveOropharyngeal Squamous Cell Carcinomap16 Positive Neoplastic Cells PresentPathologic Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Pathologic Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Pathologic Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8NCT03618134Jonsson Comprehensive Cancer Center19