We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Post-operative Radiation With Cetuximab for Locally Advanced Cutaneous Squamous Cell Carcinoma of the Head and Neck

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01979211
Recruitment Status : Active, not recruiting
First Posted : November 8, 2013
Results First Posted : May 10, 2022
Last Update Posted : May 10, 2022
Sponsor:
Information provided by (Responsible Party):
Vinita Takiar, University of Cincinnati

Brief Summary:

The standard treatment of surgery followed by radiation therapy can stop tumors from growing in the head and neck region in most patients. However, the cancer can recur or can spread to other parts of the body. Cetuximab is a drug that may delay or prevent tumor growth by blocking certain cellular chemical pathways that lead to tumor development. It was approved by the United States Food and Drug Administration (FDA) in 2006 for the treatment of head and neck cancer.

The purpose of this study is to determine how easily cetuximab can be added to treatment with radiation therapy in patients with cutaneous cancer of the head and neck. This study will also look at how well cetuximab added to radiation therapy works over time and how well this treatment is tolerated.


Condition or disease Intervention/treatment Phase
Head and Neck Cancer Drug: Cetuximab Radiation: Radiation Therapy Phase 2

Detailed Description:
This is a Phase II trial to characterize the feasibility of treating patients with locally advanced cutaneous squamous cell carcinomas of the head and neck with post-operative radiotherapy and cetuximab. Cetuximab has previously been given safely in conjunction with head and neck radiotherapy for mucosal squamous cell carcinoma in multiple phase III trials, and so Phase I data is not necessary here.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Post-operative or Definitive Concurrent Radiation and Cetuximab for Locally Advanced Cutaneous Squamous Cell Carcinoma of the Head and Neck
Study Start Date : October 2013
Actual Primary Completion Date : August 1, 2021
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Cetuximab

Arm Intervention/treatment
Experimental: Cetuximab and Radiation
Cetuximab 400 mg/m2 IV over 120 minutes loading dose > 4 days prior to initiation of radiation; Cetuximab 250 mg/m2 IV over 60 minutes weekly weeks 2-7 concurrent with Radiation therapy 60-66 Gy in 2 Gy daily fractions
Drug: Cetuximab
400 mg/m2 IV over 120 minutes week 1; 250 mg/m2 IV over 60 minutes weekly weeks 2-7
Other Name: Erbitux

Radiation: Radiation Therapy
Radiation Therapy 60-66 Gy in 2 Gy fractions starting week 2 of Cetuximab




Primary Outcome Measures :
  1. Percentage of Participants With Local Regional Control [ Time Frame: 2 years ]
    The primary endpoint of this study was 2-year locoregional control (LRC), defined as no evidence of recurrent cancer in the tumor bed and/or neck as assessed via clinical exam and imaging. Locoregional control was estimated by the Kaplan-Meier method. The Kaplan-Meier method is a statistical method used to assess survival times while factoring for censored observations (those who had LRC) and the time for them to be censored.


Secondary Outcome Measures :
  1. Percentage of Participants With Disease-free Survival [ Time Frame: 2 years ]
    The primary endpoint of this study was 2-year disease-free survival (DFS), which was the absence of locoregional recurrence or metastatic disease (biopsied when possible). DFS was estimated by the Kaplan-Meier method. The Kaplan-Meier method is a statistical method used to assess survival times while factoring for censored observations (those who were alive disease-free) and the time for them to be censored.

  2. Percentage of Participants With Overall Survival [ Time Frame: 5 years ]
    The primary endpoint of this study was 5-year overall survival (OS), defined as the absence of death from any cause during those respective time periods. OS was estimated by the Kaplan-Meier method. The Kaplan-Meier method is a statistical method used to assess survival times while factoring for censored observations (those who were alive) and the time for them to be censored.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pathologically (histologically) proven diagnosis of cutaneous squamous cell carcinoma of the head and neck
  • Clinical stage >/= T3 or >/= N1, M0 including no distant metastases
  • Gross total resection of the primary tumor with curative intent must be completed within 7 weeks of registration
  • Performance status of 0-1 within 2 weeks prior to registration
  • Age >/= 18
  • Adequate labs within 2 weeks prior to registration

Exclusion Criteria:

  • Prior invasive malignancy unless disease free for a minimum of 3 years; noninvasive cancers (For example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible) are permitted even if diagnosed and treated < 3 years ago. Patients with a history of T1-2, N0, M0 resected differentiated thyroid carcinoma are considered eligible.
  • Prior systemic chemotherapy or anti-epidermal growth factor therapy for the study cancer or for a different prior cancer
  • Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields

Information from the National Library of Medicine

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): NCT01979211


Locations
Layout table for location information
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45219
Sponsors and Collaborators
University of Cincinnati
Investigators
Layout table for investigator information
Principal Investigator: Vinita Takiar, MD University of Cincinnati
  Study Documents (Full-Text)

Documents provided by Vinita Takiar, University of Cincinnati:
Layout table for additonal information
Responsible Party: Vinita Takiar, Assistant Professor, Department of Radiation Oncology, University of Cincinnati
ClinicalTrials.gov Identifier: NCT01979211    
Other Study ID Numbers: UCHN-12-001
First Posted: November 8, 2013    Key Record Dates
Results First Posted: May 10, 2022
Last Update Posted: May 10, 2022
Last Verified: April 2022
Keywords provided by Vinita Takiar, University of Cincinnati:
head and neck cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Squamous Cell Carcinoma of Head and Neck
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Cetuximab
Antineoplastic Agents, Immunological
Antineoplastic Agents