Status:
COMPLETED
Nimotuzumab Combined With Radiotherapy for Older Patients With Esophageal Cancer: a Single, Non-control Clinical Trial
Lead Sponsor:
Chinese Academy of Medical Sciences
Conditions:
Esophageal Cancer
Eligibility:
All Genders
70+ years
Phase:
PHASE2
Brief Summary
For patients who are unable to receive surgery or having local advanced esophageal cancer stages, concurrent chemoradiotherapy is recommended. But radiotherapy is the main strategy for older patients ...
Detailed Description
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 ra...
Eligibility Criteria
Inclusion
- patients aged 70 years or older;
- treatment naive patients with histologically proven thoracic-segment EC that was inoperable and who could not tolerate CCRT;
- stage II-IV disease (supraclavicular lymph node metastasis only), according to the 6th American Joint Committee on Cancer TNM staging system;
- estimated survival time ≥3 months;
- Karnofsky performance score ≥70;
- adequate bone marrow, as well as hepatic and renal function;
- voluntary written consent provided prior to treatment.
Exclusion
- esophagobronchial or esophagomediastinal fistula;
- patients who had joined other clinical trials prior to this treatment;
- serious heart, liver, and/or kidney insufficiency;
- serious infectious disease;
- relapse disease or distant metastasis;
- recently diagnosed neoplastic diseases;
- previous receipt of surgery, chemotherapy, or radiotherapy for EC.
Key Trial Info
Start Date :
June 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2020
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT01463605
Start Date
June 1 2011
End Date
February 1 2020
Last Update
February 4 2021
Active Locations (1)
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1
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021