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: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Fudan University
• Treatments: Cetuximab; Nimotuzumab

Criteria

Inclusion Criteria:

• Histologically confirmed locally advanced NPC;

• 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 Criteria:

• 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.