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Neoplasms, Squamous Cell

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Esophageal Cancer

After esophagectomy, patients in Arm B will receive adjuvant chemotherapy, followed by elective nodal irradiation (ENI)

After esophagectomy, patients in Arm A will receive adjuvant chemotherapy only

Elective nodal irradiation (ENI)

Adjuvant chemotherapy only

Xu-Wei Cai, M.D., Ph.D.

Xiao-Long Fu, M.D., Ph.D.

Is elective nodal irradiation (ENI) necessary for patients with thoracic esophageal cancer after esophagectomy and with pathological stage of T1-2,N+,M0?

Patient Population:

Thoracic esophageal squamous cell carcinoma after esophagectomy with at least 15 lymph nodes removed for adequate nodal staging.

R0 resection; T1-2, N+, M0.

Scheme:

After esophagectomy, patients are firstly stratified by numbers of lymph node metastasis (\<3 or \>=3). Then patients are randomized to 2 arms:

Arm A:

Adjuvant chemotherapy (4 cycles).

Arm B:

Adjuvant chemotherapy (4 cycles) + Elective Nodal Irradiation (bilateral supraclavicular fossa and mediastinum).

Is ENI Necessary For Patients With Thoracic Esophageal Cancer After Esophagectomy And With Pathological Stage Of T1-2,N+,M0

Is Elective Nodal Irradiation (ENI) Necessary For Patients With Thoracic Esophageal Squamous Cell Carcinoma Who Undergo Esophagectomy And With Pathological Stage Of T1-2,N+,M0 -- A Randomized Phase Ⅲ Trial

To evaluate elective nodal irradiation (ENI) is better for the overall survival of patients with thoracic esophageal cancer after esophagectomy who with pathological stage of T1-2, N positive, M0

the incidence rate of adverse events, especially radiation-induced lung toxicity

To evaluate the rationality of ENI after esophagectomy by analyzing the therapeutic failure patterns especially by comparing the in-field and out-of-field recurrences

The First Affiliated Hospital of Soochow University

The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China

Jiangsu Cancer Institute & Hospital

Affiliated Hospital of Jiangsu University

Zhejiang Cancer Hospital

First Affiliated Hospital of Wenzhou Medical University

Zhejiang University

The First Affiliated Hospital of Anhui Medical University

Anhui Provincial Hospital

Fujian Cancer Hospital

Shanghai Chest Hospital

Shanghai Pulmonary Hospital, Shanghai, China

RenJi Hospital

Fudan University

Xiao-Long Fu / Professor

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Is ENI Necessary For Patients With Thoracic Esophageal Cancer After Esophagectomy And With Pathological Stage Of T1-2,N+,M0	NCT01398449	Esophageal Squa...	Elective nodal ... Adjuvant chemot...	18 Years - 70 Years	Fudan University
Is ENI Necessary For Patients With Thoracic Esophageal Cancer After Esophagectomy And With Pathological Stage Of T1-2,N+,M0	NCT01398449	Esophageal Squa...	Elective nodal ... Adjuvant chemot...	18 Years - 70 Years	Fudan University

Spots Global Cancer Trial Database for adjuvant chemotherapy only