Nimotuzumab Combined With Radiotherapy for Older Patients With Esophageal Cancer: a Single, Non-control Clinical Trial
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|ClinicalTrials.gov Identifier: NCT01463605|
Recruitment Status : Completed
First Posted : November 2, 2011
Last Update Posted : February 4, 2021
|Condition or disease||Intervention/treatment||Phase|
|Esophageal Cancer||Drug: Nimotuzumab||Phase 2|
Study Design Primary Purpose: To evaluate the response rate, progression-free survival, overall survival and complications.
Study Phase: Phase II Intervention Model: Targeted therapy combined with radiotherapy Number of Arms: One Masking: No Allocation: 30 patients for one single group Enrollment: 30 patients
Eligibility Criteria Inclusion Criteria: 1. ≥ 70 year-old, 2. Thoracic segment esophageal cancer with stage II to IV (supraclavicular lymph node metastasis only), 3. No previous surgery, radiotherapy or chemotherapy of cancer was allowed, 4. Estimated survival time ≥ 3 months, 5. KPS > 60, 6. No serious diseases of important organs, 7. Signed consent forms voluntarily.
Exclusion Criteria: 1. Psychopath, 2. History of other malignant disease which has not been cured, 3. Joining other clinical trial prior this study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||46 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Nimotuzumab Combined With Radiotherapy for Older Patients With Esophageal Cancer: a Single, Non-control Phase II Clinical Trial|
|Actual Study Start Date :||June 2011|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||February 2020|
It is just a single group assignment
Nimotuzumab 200mg,once per week,for 5 to 6 weeks
- Safety of Nimotuzumab combined with Radiotherapy for older patients [ Time Frame: 2 years ]To observe the adverse events during the treatment
- Efficacy of Nimotuzumab combined with Radiotherapy for older esophageal cancer patients [ Time Frame: 3 years ]To observe the response rate, progress-free survival and overall survival
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): NCT01463605
|Cancer Hospital, Chinese Academy of Medical Sciences|
|Beijing, Beijing, China, 100021|
|Principal Investigator:||Liang Jun, Doctor||Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences|