Chemoradiation With or Without Nimotuzumab in Treating Esophageal Cancer Patients Who Suffer With Recurrence in Regional Lymph Nodes After Esophagectomy (Nimotuzumab)
Recruitment status was: Recruiting
Esophageal Squamous Cell Carcinoma
Radiation: Radiation therapy
Radiation: radiation therapy
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomized Phase II Trial Evaluating The Addition Of Nimotuzumab To Chemoradiation For Patients With Esophageal Squamous Cell Carcinoma After Radical Esophagectomy Who Suffer With Lymph Nodes Recurrence|
- Local control [ Designated as safety issue: No ]To evaluate if the addition of nimotuzumab to chemoradiation improves local control compared to chemoradiation only in patients with esophageal squamous cell carcinoma after radical esophagectomy who recurrent in regional lymph nodes.
- Overall survival [ Designated as safety issue: No ]To evaluate if the addition of nimotuzumab to chemoradiation improves overall survival compared to chemoradiation only in patients with esophageal squamous cell carcinoma after radical esophagectomy who recurrent in regional lymph nodes.
- Adverse Events [ Designated as safety issue: Yes ]
|Study Start Date:||December 2010|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Patients randomized in Arm A will receive chemoradiation and weekly Nimotuzumab for 6 weeks concurrent with radiation
|Biological: Nimotuzumab Radiation: Radiation therapy Drug: chemotherapy|
Active Comparator: B
Patients randomized in Arm B will receive chemoradiation only
|Radiation: radiation therapy Drug: chemotherapy|
Esophageal squamous cell carcinoma after radical esophagectomy, then recurrent with lymph nodes in bilateral supravascular fossa or upper mediastinum 6 months beyond esophagectomy.
Eligible recurrent patients with esophageal cancer will first be stratified by recurrent time after esophagectomy (within 2 years after esophagectomy, or beyond 2 years after esophagectomy), then randomized to 2 arms at 1:1 ratio.
Chemoradiation + weekly Nimotuzumab for 6 weeks concurrent with radiation.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01402180
|Fudan University Cancer Center|
|Shanghai, Shanghai, China, 200032|
|Principal Investigator:||Xiao-Long Fu, M.D, Ph.D.||Fudan University|