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Anti-EGFR Therapy Plus IMRT Concurrent Chemoradiotherapy in Locally Advanced NPC Resistant to Induction Chemotherapy

NCT04508816 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2022-04-04

No results posted yet for this study

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.

Conditions

  • Nasopharyngeal Carcinoma

Interventions

DRUG

cetuximab (CTX) or nimotuzumab (NTZ)

The patients will receive IMRT combined with anti-EGFR monoclonal antibody concurrent chemoradiotherapy. The specific treatment description is included in arm description.

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Principal Investigators

  • Xiaoshen Wang, MD, Ph.D · Fudan University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-01-01
Primary Completion
2020-10-01
Completion
2020-10-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04508816 on ClinicalTrials.gov