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 cancer after esophagectomy and with pathological stage of T1-2,N+,M0?
Esophageal Squamous Cell Carcinoma
Radiation: Elective nodal irradiation (ENI)
Other: Adjuvant chemotherapy only
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Overall survival [ Designated as safety issue: No ]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
- Locoregional control rate [ Designated as safety issue: No ]
- Safety and Tolerability (incidence rate of adverse events) [ Designated as safety issue: Yes ]the incidence rate of adverse events, especially radiation-induced lung toxicity
- Failure pattern [ Designated as safety issue: No ]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
|Study Start Date:||April 2011|
|Estimated Study Completion Date:||December 2017|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
After esophagectomy, patients in Arm B will receive adjuvant chemotherapy, followed by elective nodal irradiation (ENI)
|Radiation: Elective nodal irradiation (ENI)|
Active Comparator: A
After esophagectomy, patients in Arm A will receive adjuvant chemotherapy only
|Other: Adjuvant chemotherapy only|
Thoracic esophageal squamous cell carcinoma after esophagectomy with at least 15 lymph nodes removed for adequate nodal staging.
R0 resection; T1-2, N+, M0.
After esophagectomy, patients are firstly stratified by numbers of lymph node metastasis (<3 or >=3). Then patients are randomized to 2 arms:
Adjuvant chemotherapy (4 cycles).
Adjuvant chemotherapy (4 cycles) + Elective Nodal Irradiation (bilateral supraclavicular fossa and mediastinum).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01398449
|Contact: Xu-Wei Cai, M.D., Ph.D.||8621-64175590 ext email@example.com|
|Fudan University Cancer Center||Recruiting|
|Shanghai, Shanghai, China, 200032|
|Contact: Xu-Wei Cai, M.D., Ph.D. 8621-64175590 ext 1504 firstname.lastname@example.org|
|Principal Investigator: Xiao-Long Fu, M.D., Ph.D.|