跳至主要内容
临床试验/NCT02279134
NCT02279134进行中(未招募)2 期

A Phase II/III Study of Adjuvant Chemoradiotherapy, Radiotherapy After Surgery Versus Surgery Alone in Patients With Stage ⅡB-Ⅲ Esophageal Carcinoma

Zefen Xiao1 个研究点 分布在 1 个国家目标入组 360 人开始时间: 2014年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
进行中(未招募)
发起方
入组人数
360
试验地点
1
主要终点
Disease-free survival (DFS)

研究概览

简要总结

This phase III trial is studying how well the combination of chemoradiation or radiation works in resected locally advanced cancer of the esophagus or gastroesophageal junction.

详细描述

Although preoperative chemoradiation therapy followed by surgery is the most common approach for patients with resectable esophageal cancer, considerable number of esophageal cancer patients received operation as the first treatment modality. Accordingly, postoperative treatments have always been playing an important role because of the poor survival rates of the patients in stage ⅡB[UICC 7th edition] -Ⅲ[UICC 7th edition] who have been treated with resection alone. The existing data shows that the 5-yeal survival rate of stageⅡB-Ⅲ of thoracic esophageal squamous cell carcinoma(TESCC) after surgery is merely about 28.4% ,and locoregional lymph nodes metastases is responsible for the main cause of failure. While we have proved the value of prophylactic radiation therapy after radical esophagectomy for esophageal carcinoma with positive lymph node metastases and stage Ⅲ disease (UICC 6th edition) under the conventional 2-dimensional radiotherapy methods in subset analysis of prospective randomized clinical trial. For patients with positive lymph nodes, 5 year survival after surgery alone was 28.4%, median overall survival was 24 months, recurrence patterns were 34.6% in mediastinal lymph nodes,13.3% in supraclavicular lymph nodes,10% in abdominal lymph nodes. Distant metastases occurred in 21% patients. Adjuvant radiotherapy significantly reduced the recurrence in mediastinal lymph nodes(13.4%), supraclavicular lymph nodes (6.1%). However distant metastases rate increased to 30.7%. Chemotherapy may be vital for these patients. Chen reported that 5 year overall survival rates for the chemoradiotherapy group and radiotherapy group were 47.4% and 38.6% (P=0.03). Based on our studies, treatment failure occurred in 8% patients because of celiac metastases. Small radiation field by omitting celiac drainage region may ensure patients to accept 2 cycles of concurrent chemotherapy for lower toxicity.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 68 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of stage ⅡB or Ⅲ thoracic esophageal cancer
  • Complete resection
  • Adequate organ function:
  • Hematopoietic Absolute granulocyte count at least 1,500/mm^3 Platelet count at least 150,000/mm^3 Hemoglobin at least 10 g/dL Hepatic Not specified Renal Creatinine no greater than 1.5 mg/dL AND/OR Creatinine clearance at least 65 mL/min Calcium no greater than 11 mg/dL Cardiovascular No uncontrolled heart disease No uncontrolled hypertension

排除标准

  • Uncontrolled diabetes
  • Interval between surgery and adjuvant therapy more than 3 months
  • Sign of recurrence on CT scan or ultrasound or PET-CT No palpable subclavicular lymph nodes or involvement after cytology needle aspiration No lymph nodes greater than 1 cm on CT scan
  • With Weight loss greater than 10% from baseline
  • With other prior or concurrent malignancy except basal cell skin cancer or carcinoma in situ of the cervix
  • Be pregnant

研究组 & 干预措施

Adjuvant Chemoradiation

Experimental

Adjuvant chemoradiation after radical resection is developed in this arm

干预措施: Adjuvant Chemoradiation (Radiation)

Adjuvant Chemoradiation

Experimental

Adjuvant chemoradiation after radical resection is developed in this arm

干预措施: Paclitaxel (Drug)

Adjuvant Chemoradiation

Experimental

Adjuvant chemoradiation after radical resection is developed in this arm

干预措施: Cisplatin or Nedaplatin (Drug)

Adjuvant Radiation

Active Comparator

Adjuvant radiation after radical resection is developed in this arm

干预措施: Adjuvant Radiation (Radiation)

结局指标

主要结局

Disease-free survival (DFS)

时间窗: up to 3 years

From the date of randomization to the date of first failure or last follow-up

次要结局

  • Overall survival (OS)(up to 5 years)

研究者

发起方
Zefen Xiao
申办方类型
Unknown
责任方
Sponsor Investigator
主要研究者

Zefen Xiao

Chinese Academy of Medical Sciences

Chinese Academy of Medical Sciences

研究点 (1)

Loading locations...

相似试验

进行中(未招募)
3 期
Phase Ⅲ Trial of Adjuvant Chemotherapy in Patients With N2-3 Nasopharyngeal CarcinomaNasopharyngeal Carcinoma
NCT03321539Sun Yat-sen University216
已完成
3 期
Cisplatin and Radiation Therapy With or Without Carboplatin and Paclitaxel in Patients With Locally Advanced Cervical CancerCervical AdenocarcinomaCervical Adenosquamous CarcinomaCervical Squamous Cell Carcinoma, Not Otherwise SpecifiedStage IB Cervical Cancer AJCC v6 and v7Stage IIA Cervical Cancer AJCC v7Stage IIB Cervical Cancer AJCC v6 and v7Stage IIIB Cervical Cancer AJCC v6 and v7Stage IVA Cervical Cancer AJCC v6 and v7
NCT01414608GOG Foundation926
已完成
3 期
Radiation Therapy With or Without Chemotherapy in Patients With Stage I-IIA Cervical Cancer Who Previously Underwent SurgeryCervical AdenocarcinomaCervical Adenosquamous CarcinomaCervical Squamous Cell Carcinoma, Not Otherwise SpecifiedStage I Cervical Cancer AJCC v6 and v7Stage IA Cervical Cancer AJCC v6 and v7Stage IB Cervical Cancer AJCC v6 and v7Stage IIA Cervical Cancer AJCC v7
NCT01101451GOG Foundation340
招募中
3 期
Evaluation of Concomitant Chemo-radiotherapy With Cisplatine vs Gemcitabin in Locally Advanced Cervicouterine CancerLocally Advanced Cervical CancerGemcitabineChemo-radiotherapy
NCT06156514National Institute of Cancerología140
暂停
2 期
Testing Docetaxel-Cetuximab or the Addition of an Immunotherapy Drug, Atezolizumab, to the Usual Chemotherapy and Radiation Therapy in High-Risk Head and Neck CancerOropharyngeal p16INK4a-Negative Squamous Cell CarcinomaStage III Hypopharyngeal Squamous Cell Carcinoma AJCC v7Stage III Laryngeal Squamous Cell Carcinoma AJCC v6 and v7Stage III Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7Stage III Oropharyngeal Squamous Cell Carcinoma AJCC v7Stage IV Hypopharyngeal Squamous Cell Carcinoma AJCC v7Stage IV Laryngeal Squamous Cell Carcinoma AJCC v7Stage IV Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7Stage IV Oropharyngeal Squamous Cell Carcinoma AJCC v7
NCT01810913National Cancer Institute (NCI)613
Phase II/III Study Compare Adjuvant... | 临床试验