Status:
UNKNOWN
Anti-EGFR Therapy With IMRT Concurrent Chemoradiotherapy in Locally Advanced OPC Resistant to Induction Chemotherapy
Lead Sponsor:
Fudan University
Conditions:
Oropharyngeal Carcinoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
This study is a prospective phase II trial which is designed to evaluate the efficacy and safety of IMRT combined with concurrent chemotherapy and anti-EGFR monoclonal antibody in locally advanced oro...
Detailed Description
This study is a prospective phase II trial which is designed to evaluate the efficacy and safety of IMRT combined with concurrent chemotherapy and anti-EGFR monoclonal antibody in locally advanced oro...
Eligibility Criteria
Inclusion
- Histologically confirmed locally advanced OPC with Induced chemotherapy resistance;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- Normal complete blood count;
- Normal hepatic function;
- Normal renal function (creatinine ≤ 1.5 times the upper limit of normal).
Exclusion
- Previous radiotherapy;
- A history of any other type of malignancy;
- Pregnancy or lactation;
- Allergy to anti-EGFR monoclonal antibody;
- Obvious disfunction of liver, renal, cardiac or lung function;
- Un controlled infection;
- Systemic metastasis or distant metastasis;
- Patients with severe gastrointestinal diseases;
- Patients with mental disorders affecting patient participation in trial judgement.
Key Trial Info
Start Date :
January 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT04508829
Start Date
January 1 2016
End Date
December 1 2023
Last Update
April 4 2022
Active Locations (1)
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1
Fudan University Shanghai Cancer Center
Shanghai, China, 200032