Anti-EGFR Therapy With IMRT Concurrent Chemoradiotherapy in Locally Advanced NPC With Induced Chemotherapy Resistance
Status:
Recruiting
Trial end date:
2020-12-01
Target enrollment:
Participant gender:
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 nasopharyngeal carcinoma with induced chemotherapy resistance.
Eligibility criteria include histologically confirmed locally advanced NPC according to the
American Joint Committee on Cancer (AJCC) Staging System (the eighth edition); Eastern
Cooperative Oncology Group (ECOG) performance status of 0 or 1; at least one measurable
lesion based on the Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.1;
normal complete blood count, normal hepatic function and normal renal function.
Exclusion criteria include previous radiotherapy, a history of any other type of malignancy;
pregnancy or lactation; allergy to anti-EGFR monoclonal antibody; obvious dysfunction of
liver, renal, cardiac or lung function; uncontrolled infection; systemic metastasis or
distant metastasis; patients with severe gastrointestinal diseases, and patients with mental
disorders affecting patient participation in trial judgement.
The full-set pretreatment evaluation will be performed to every patient. All patients in this
study will receive intensity-modulated radiation therapy (IMRT). The primary endpoints of
this study is progression-free survival (PFS) and adverse events (AE) rate.