Chemoradiation With or Without Nimotuzumab in Treating Esophageal Cancer Patients Who Suffer With Recurrence in Regional Lymph Nodes After Esophagectomy (Nimotuzumab)
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|ClinicalTrials.gov Identifier: NCT01402180|
Recruitment Status : Unknown
Verified November 2010 by Fudan University.
Recruitment status was: Recruiting
First Posted : July 26, 2011
Last Update Posted : July 26, 2011
|Condition or disease||Intervention/treatment||Phase|
|Esophageal Squamous Cell Carcinoma||Biological: Nimotuzumab Radiation: Radiation therapy Radiation: radiation therapy Drug: chemotherapy||Phase 2 Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||128 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||December 2010|
|Estimated Primary Completion Date :||December 2013|
|Estimated Study Completion Date :||December 2015|
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|
- Local controlTo 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 survivalTo 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
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): NCT01402180
|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.|
|Principal Investigator:||Xiao-Long Fu, M.D, Ph.D.||Fudan University|