Head and Neck CancerPhase 2NCT01979211
Post-operative Radiation With Cetuximab for Locally Advanced Cutaneous Squamous Cell Carcinoma of the Head and Neck
A Phase 2 study testing Cetuximab and Radiation Therapy in people with Head and Neck Cancer, run by University of Cincinnati at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Cetuximab and Radiation Therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to 19 Jan 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Head and Neck Cancer
- Being tested
- Cetuximab, Radiation Therapy
- Keywords
- head and neck cancer
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CetuximabDrug
Also called Erbitux
400 mg/m2 IV over 120 minutes week 1; 250 mg/m2 IV over 60 minutes weekly weeks 2-7
Radiation TherapyRadiation
Radiation Therapy 60-66 Gy in 2 Gy fractions starting week 2 of Cetuximab
| Study group | Role | What they receive |
|---|---|---|
| Cetuximab and Radiation | Experimental | 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 Receives: Drug: Cetuximab; Radiation: Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Local Regional Control
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.
Measured: 2 years
Secondary outcomes (2)
Percentage of Participants With Disease-free Survival
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.
Measured: 2 years
Percentage of Participants With Overall Survival
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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2013 (estimated)
- Study startOct 2013
- Primary completion19 Jan 2022
- Study completion19 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vinita Takiar, University of Cincinnati
- Investigators
- Vinita Takiar, MD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01979211
- Sponsor's protocol ID
- UCHN-12-001
- Status last verified
- Feb 2024
- First submitted
- 24 Oct 2013
- Last updated
- 29 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01979211
- Acronym / sponsor ID
- UCHN-12-001
- Conditions
- Head and Neck Cancer
- Keywords
- head and neck cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- 19 Jan 2022 (actual)
- Study completion
- 19 Jan 2022 (actual)
- First posted
- 8 Nov 2013 (estimated)
- Results
- Posted 10 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cetuximab and Radiation | Experimental | Drug: Cetuximab, Radiation: Radiation TherapyCetuximab 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CetuximabAlso: Erbitux400 mg/m2 IV over 120 minutes week 1; 250 mg/m2 IV over 60 minutes weekly weeks 2-7 | Drug | Cetuximab and Radiation |
| Radiation TherapyRadiation Therapy 60-66 Gy in 2 Gy fractions starting week 2 of Cetuximab | Radiation | Cetuximab and Radiation |
Primary outcome
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.
2 secondary outcomes
Percentage of Participants With Disease-free Survival
Time frame: 2 years
Percentage of Participants With Overall Survival
Time frame: 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vinita Takiar, MD principal investigator
University of Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cetuximab and Radiation Therapy in people with Head and Neck Cancer, run by University of Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Local Regional Control (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Feb 2024; AzTrials last refreshed its copy on 6 Nov 2026.