Completed

A Phase II Randomized Trial Of Surgery Followed By Chemoradiotherapy Plus Cetuximab For Advanced Squamous Cell Carcinoma Of The Head and Neck

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What is being tested

cetuximab

+ cisplatin

+ radiation therapy

BiologicalDrugRadiation
Who is being recruted

Carcinoma+3

+ Carcinoma, Squamous Cell

+ Neoplasms

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: April 2004
See protocol details

Summary

Principal SponsorRadiation Therapy Oncology Group
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2004

Actual date on which the first participant was enrolled.

OBJECTIVES: Primary * Compare disease-free survival of patients with resected stage III or IV squamous cell carcinoma or lymphoepithelioma of the head and neck treated with adjuvant cetuximab in combination with chemoradiotherapy comprising docetaxel vs cisplatin. Secondary * Compare the safety and efficacy of these regimens in these patients. * Compare locoregional control and overall survival rates in patients treated with these regimens. * Correlate epidermal growth factor receptor (total and phosphorylated), pMAPK, pAKT, Stat-3, Ki-67, cyclo-oxygenase-2, and cyclin B1 expression with outcome in patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to Zubrod performance status (0 vs 1), risk category (positive margins vs high risk \[i.e., ≥ 2 positive nodes or extracapsular nodal extension\]) and use of intensity-modulated radiotherapy (no vs yes). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive cetuximab IV over 2 hours on day 1 (week 1). Patients then receive cetuximab IV over 1 hour and cisplatin IV over 1 hour before radiotherapy on days 8, 15, 22, 29, 36, and 43 (weeks 2-7). Patients undergo radiotherapy once daily, 5 days a week, beginning on day 8 for a total of 6 weeks (weeks 2-7). * Arm II: Patients receive cetuximab and undergo radiotherapy as in arm I. Patients also receive docetaxel IV over 30 minutes before radiotherapy on days 8, 15, 22, 29, 36, and 43 (weeks 2-7). Treatment in both arms continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years and then every 6 months for 4 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 230 patients (115 per treatment arm) will be accrued for this study within approximately 29 months.

Official TitleA Phase II Randomized Trial Of Surgery Followed By Chemoradiotherapy Plus Cetuximab For Advanced Squamous Cell Carcinoma Of The Head and Neck 
NCT00414674NCT00084318
Principal SponsorRadiation Therapy Oncology Group
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

238 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

CarcinomaCarcinoma, Squamous CellNeoplasmsNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialNeoplasms, Squamous Cell

Criteria

DISEASE CHARACTERISTICS: * Histologically confirmed squamous cell carcinoma of the head and neck meeting the following criteria: * Site of tumor origin in the oral cavity, oropharynx, larynx, or hypopharynx (excluding lip, nasopharynx, or sinuses) * Gross total resection must be completed within 7 weeks of randomization, with pathology demonstrating one or more of the following risk factors: * Histologic extracapsular nodal extension * Histologic involvement of ≥ 2 regional lymph nodes * Invasive cancer seen on microscopic evaluation of the resection margin, with no evidence of gross tumor residual. * Tonsillar cancer patients who undergo transoral excision of all gross tumor are eligible provided extracapsular nodal extension or involvement of ≥ 2 regional lymph nodes is histologically confirmed * American Joint Committee on Cancer (AJCC) pathological stage III or IV * No evidence of distant metastases * No synchronous or concurrent head and neck primary tumors PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Zubrod 0-1 Life expectancy * Not specified Hematopoietic * Absolute neutrophil count ≥ 2,000/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin \> 8.0 g/dL Hepatic * Bilirubin ≤ 1.5 times upper limit of normal (ULN) * Aspartate aminotransferase (AST) or alanine aminotransferase (ALT), and alkaline phosphatase meeting 1 of the following parameters: * Alkaline phosphatase ≤ ULN AND AST or ALT ≤ 5 times ULN * Alkaline phosphatase ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN * Alkaline phosphatase ≤ 5 times ULN AND AST or ALT ≤ ULN Renal * Creatinine ≤ 1.5 mg/dL Cardiovascular * No unstable angina * No uncontrolled hypertension * No myocardial infarction within the past 6 months (unless successfully treated with coronary artery bypass surgery or percutaneous transluminal coronary angioplasty) * No uncontrolled arrhythmia * No congestive heart failure * No more than 2 heart-related hospitalizations within the past year * No other active cardiac disease Pulmonary * No more than 2 hospitalizations for chronic obstructive pulmonary disease within the past year Neurologic * No pre-existing peripheral neuropathy ≥ grade 2 * No uncontrolled seizure disorder * No active neurological disease Other * No prior severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 * No other invasive malignancy within the past 3 years except nonmelanoma skin cancer * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after study participation PRIOR CONCURRENT THERAPY: Biologic therapy * No prior anti-epidermal growth factor receptor antibody therapy Chemotherapy * More than 3 years since prior cytotoxic chemotherapy Endocrine therapy * Not specified Radiotherapy * No prior head and neck radiotherapy Surgery * See Disease Characteristics Other * No prior tyrosine kinase inhibitor therapy

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Loading dose of cetuximab followed by radiation therapy with weekly cisplatin and cetuximab.

Group II

Experimental
Loading dose of cetuximab followed by radiation therapy (RT) with weekly docetaxel and cetuximab.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 160 locations

Suspended

University of Alabama at Birmingham Comprehensive Cancer Center

Birmingham, United StatesSee the location
Suspended

Mobile Infirmary Medical Center

Mobile, United States
Suspended

Arizona Oncology Services Foundation

Phoenix, United States
Suspended

Virginia G. Piper Cancer Center at Scottsdale Healthcare - Osborn

Scottsdale, United States
Completed160 Study Centers