Is ENI Necessary For Patients With Thoracic Esophageal Cancer After Esophagectomy And With Pathological Stage Of T1-2,N+,M0
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|ClinicalTrials.gov Identifier: NCT01398449|
Recruitment Status : Unknown
Verified March 2011 by Fudan University.
Recruitment status was: Recruiting
First Posted : July 20, 2011
Last Update Posted : July 20, 2011
|Condition or disease||Intervention/treatment||Phase|
|Esophageal Squamous Cell Carcinoma||Radiation: Elective nodal irradiation (ENI) Other: Adjuvant chemotherapy only||Phase 3|
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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||874 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||April 2011|
|Estimated Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||December 2017|
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|
- Overall survivalTo 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
- Safety and Tolerability (incidence rate of adverse events)the incidence rate of adverse events, especially radiation-induced lung toxicity
- Failure patternTo evaluate the rationality of ENI after esophagectomy by analyzing the therapeutic failure patterns especially by comparing the in-field and out-of-field recurrences
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01398449
|Contact: Xu-Wei Cai, M.D., Ph.D.||8621-64175590 ext firstname.lastname@example.org|
|Fudan University Cancer Center||Recruiting|
|Shanghai, Shanghai, China, 200032|
|Contact: Xu-Wei Cai, M.D., Ph.D. 8621-64175590 ext 1504 email@example.com|
|Principal Investigator: Xiao-Long Fu, M.D., Ph.D.|