Anti-EGFR Therapy With IMRT Concurrent Chemoradiotherapy in Locally Advanced OPC Resistant to Induction Chemotherapy

NCT04508829 | Unknown Phase 2 DMC

• 1 other identifier: OPC-anti-EGFR-01
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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 oropharyngeal carcinoma (OPC) with induced chemotherapy resistance. Eligibility criteria include histologically confirmed locally advanced OPC 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. Prior induction chemotherapy with platinum was allowed. 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

Oropharyngeal Carcinoma

Keywords

oropharyngeal carcinoma; IMRT; anti-EGFR monoclonal antibody; induced chemotherapy resistance

Outcome Measures

Primary Outcomes (1)

• PFS

  PFS is calculated from the date of the enrollment to the date of disease progression or the date of death for any cause.

  3-year PFS

Study Arms (1)

Anti-EGFR arm

EXPERIMENTAL

In the induction chemotherapy phase, TP regimen (Docetaxel 75mg/m2, D1 + DDP 25mg/m2, D1-3, repeat every 3 weeks) or TPF regimen (Docetaxel 75mg/m2, D1 + DDP 25mg/m2, D1-3+5-FU 750mg/m2, CIV, 120h, repeat every 3 weeks) will be used. Cetuximab 400mg/m2 will be used one week before radiotherapy and 250mg/m2/week during IMRT, or nimotuzumab 200mg/week; meanwhile, cisplatin 80mg/m2 will be used every 3 weeks.

Drug: Anti-EGFR monoclonal antibody

Interventions

Anti-EGFR monoclonal antibody DRUG

The patients will receive IMRT combined with anti-EGFR monoclonal antibody concurrent chemoradiotherapy in locally advanced oropharyngeal carcinoma with induced chemotherapy resistance. The specific treatment description is included in arm description.

Anti-EGFR arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, 200032, China

RECRUITING

MeSH Terms

Conditions

Oropharyngeal Neoplasms

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Central Study Contacts

Xiaoshen Wang, MD, Ph.D

CONTACT

+8618017312704; ruijin702@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Single Group Assignment

Study Record Dates

• First Submitted: August 9, 2020
• First Posted: August 11, 2020
• Study Start: January 1, 2016
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: April 4, 2022

Record last verified: 2022-03

Locations

CN (1)