Cetuximab and Radiation Therapy in Treating Patients With Stage III-IV Head and Neck Cancer
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|ClinicalTrials.gov Identifier: NCT02177838|
Recruitment Status : Recruiting
First Posted : June 30, 2014
Last Update Posted : June 14, 2019
|Condition or disease||Intervention/treatment||Phase|
|Stage III Squamous Cell Carcinoma of the Hypopharynx Stage III Squamous Cell Carcinoma of the Larynx Stage III Squamous Cell Carcinoma of the Oropharynx Stage III Verrucous Carcinoma of the Larynx Stage IV Squamous Cell Carcinoma of the Hypopharynx Stage IVA Squamous Cell Carcinoma of the Larynx Stage IVA Squamous Cell Carcinoma of the Oropharynx Stage IVA Verrucous Carcinoma of the Larynx Stage IVB Squamous Cell Carcinoma of the Larynx Stage IVB Squamous Cell Carcinoma of the Oropharynx Stage IVB Verrucous Carcinoma of the Larynx Tongue Cancer||Biological: cetuximab Drug: cisplatin Radiation: external beam radiation therapy Other: laboratory biomarker analysis||Not Applicable|
I. 2 year (yr) locoregional control in cetuximab responders.
I. Assess secondary clinical endpoints such as the percent of patients receiving neoadjuvant cetuximab who progress by computed tomography (CT) Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria during the neoadjuvant cetuximab, the 2 yr locoregional control for non-responders to neoadjuvant cetuximab, and the complete response rate to positron emission tomography (PET)/computed tomography (CT) scan 3 months after the completion of radiation therapy for both responders and for non-responders to neoadjuvant cetuximab.
II. Analyze the relationship of known deoxyribonucleic acid (DNA) mutations in tumor per the FoundationOne genomic profile, and correlate to clinical endpoints such as locoregional control.
II. Analyze any changes in protein production at the tumor in response to 3 weeks of cetuximab.
III. Analyze any changes in protein production at the skin in response to 3 weeks of cetuximab.
IV. To investigate whether the tumor imaging characteristics including anatomical and molecular parameters evaluated by PET/CT, either alone or combined with other biomarkers can attribute to the better prediction for the clinical outcomes, as the response to neoadjuvant cetuximab; and the final clinical endpoint, the 2-year local regional controls.
Patients receive cetuximab intravenously (IV) over 60-120 minutes for 3 weeks. Patients then undergo external beam radiation therapy (EBRT) over 6-7 weeks. Patients achieving response continue weekly doses of cetuximab until radiation therapy is completed. Patients unable to achieve response or progression receive cisplatin IV over 1-2 hours on days 1, 22, and 43 of radiation therapy.
After completion of study treatment, patients are followed up every 3 months for 2 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||27 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Selecting for Cetuximab Responders in Advanced Head and Neck SCC|
|Actual Study Start Date :||March 25, 2015|
|Estimated Primary Completion Date :||June 1, 2020|
|Estimated Study Completion Date :||June 1, 2020|
Experimental: Treatment (cetuximab, cisplatin, EBRT)
Patients receive cetuximab IV over 60-120 minutes for 3 weeks. Patients then undergo EBRT over 6-7 weeks. Patients achieving response continue weekly doses of cetuximab until radiation therapy is completed. Patients unable to achieve response or progression receive cisplatin IV over 1-2 hours on days 1, 22, and 43 of radiation therapy.
Radiation: external beam radiation therapy
Other Name: EBRT
Other: laboratory biomarker analysis
- Locoregional control in cetuximab responders [ Time Frame: 2 years ]
- Percent of patients who progress during neoadjuvant cetuximab by CT RECIST 1.1 criteria [ Time Frame: Day 14-21 after the first dose of cetuximab ]Will be descriptive.
- Locoregional control for non-responders to neoadjuvant cetuximab [ Time Frame: 2 years ]Will be descriptive.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02177838
|United States, New Jersey|
|New Jersey Medical School||Recruiting|
|Newark, New Jersey, United States, 07103|
|Contact: Clinical Trials Office 732-235-8675|
|Contact: Joanne Natasha Nicholls 9739721881 email@example.com|
|Principal Investigator: Sung Kim|
|Principal Investigator:||Sung Kim||Rutgers Cancer Institute of New Jersey|