Active not recruitingPHASE3INTERVENTIONAL

RT With or Without Cetuximab in Treating Patients Who Have Undergone Surgery for Locally Advanced Head and Neck Cancer

This research trial is for people who have had surgery for head and neck cancer that is quite advanced. We are comparing two treatments: standard radiation therapy and radiation therapy combined with a drug called cetuximab. Radiation therapy uses focused energy to kill cancer cells, while cetuximab is a special drug that can help block cancer growth. The main goal is to find out if adding cetuximab leads to better overall survival for patients. We also want to see if it helps prevent the cancer from coming back and how it affects side effects like difficulty swallowing, dry mouth, or skin problems. Your participation helps us understand the best ways to treat head and neck cancer.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Radiation Therapy Oncology Group

Enrolment target

702

Start

31 Mar 2010

Estimated completion

01 Aug 2029

Head and Neck Cancer

Results

Results from this study

Posted May 2024

Results have been published for this study.

Primary outcome

Percentage of Participants Alive (Overall Survival)

Overall survival time is defined as time from registration/randomization to the date of death from any cause or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method. Analysis occurred after all participants had potentially been on study for at least 5 years. The distributions of survival times are compared, which is reported in the statistical analysis results. Five-year rates are provided.

Full results on the registry

What is this study about?

Imagine your head and neck cancer has been removed by surgery. Now, doctors often suggest radiation therapy to make sure any tiny remaining cancer cells are destroyed. This study is exploring a new idea: could adding a special drug called cetuximab to this radiation therapy make the treatment even better?

Radiation therapy, in this study, uses a very modern technique that creates a 3D image of the tumour area. This allows doctors to aim thin beams of radiation very precisely at the remaining cancer cells, often giving higher doses in a shorter time. This approach aims to kill more cancer cells while causing fewer side effects to healthy tissues. Cetuximab is a type of drug called a monoclonal antibody. Think of it like a smart bomb that can specifically target cancer cells. It works by blocking signals that cancer cells use to grow and spread.

The main point of this research is to see if combining this modern radiation therapy with cetuximab works better than just using radiation therapy alone. We want to know if this combination can help people live longer, reduce the chances of cancer coming back, and how it affects their quality of life. By taking part, you’d be helping doctors learn more about the most effective ways to treat head and neck cancer, potentially helping many people in the future.

Key takeaways

This study compares standard radiation with radiation plus cetuximab for head and neck cancer after surgery.
The main aim is to see if adding cetuximab improves how long patients live.
We also want to understand side effects and quality of life.
You would receive modern, precise radiation therapy.
Your participation helps improve future treatments for head and neck cancer.

Who may be eligible?

This study is looking for adults aged 18 or over who have been diagnosed with certain types of head and neck cancer, specifically from the mouth, throat (oropharynx), or voice box (larynx). Your cancer must be what doctors call 'locally advanced,' meaning it hasn't spread to other distant parts of your body.

To be considered, you must have had surgery to remove the main tumour, and this surgery must have been completed within the last seven weeks. Your doctors will also look at your surgical report to see if there are certain 'risk factors,' such as cancer cells being very close to the edge of the removed tissue, or if the cancer had spread to some lymph nodes in your neck, or if the tumour was a certain size. These factors indicate a higher chance of the cancer coming back.

Your general health will also be assessed to make sure you're well enough to take part in the study. Importantly, the type of cancer must be confirmed by looking at the cells under a microscope. If your cancer started in a different part of the throat called the hypopharynx, this study might not be suitable for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Have I been diagnosed with squamous cell head and neck cancer (e.g., mouth, throat, voice box)?
Has my cancer already been removed by surgery within the last 7 weeks?
Are my doctors concerned about 'intermediate risk factors' from my surgery report (e.g., close margins, specific lymph node involvement)?
Am I generally well, and over 18 years old?
Has my cancer not spread to distant parts of my body?
My cancer is not in the hypopharynx.

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will be assigned by chance to one of two groups: one group will receive radiation therapy only, and the other will receive radiation therapy plus cetuximab. The radiation therapy will be given using a very precise method. Cetuximab is given through a drip into your vein. The research team will regularly check in with you to see how you are doing, monitor any side effects, and assess your cancer.

You'll have a series of appointments for your treatment, usually daily for several weeks, depending on your radiation schedule. After treatment finishes, there will be follow-up visits and assessments over a period of time, which could be up to two years or more, to monitor your health and the cancer. These check-ups will include physical examinations, questionnaires about your quality of life, and possibly further scans. The total duration of active treatment is usually several weeks, but monitoring and follow-up will continue for much longer.

Potential risks and benefits

Participating in this study might offer a potential benefit if the combination treatment proves more effective than standard care. You will also receive careful medical attention throughout the study. However, there are potential risks, primarily from the treatments themselves. Radiation therapy can cause side effects like skin redness, soreness, swallowing difficulties, and dry mouth. Cetuximab can also have side effects, which your doctor will explain to you. All possible side effects will be carefully monitored, and the research team will help manage them. You are free to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (264)

University of Alabama at Birmingham
Verified postcode
Birmingham, United States
Arizona Oncology Associates-West Orange Grove
Verified postcode
Tucson, United States
Sutter Cancer Centers Radiation Oncology Services-Auburn
Verified postcode
Auburn, United States
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
Verified postcode
Cameron Park, United States
Mercy San Juan Medical Center
Verified postcode
Carmichael, United States
City of Hope
Verified postcode
Duarte, United States
UC San Diego Moores Cancer Center
Verified postcode
La Jolla, United States
Kaiser Permanente Los Angeles Medical Center
Verified postcode
Los Angeles, United States
Los Angeles County-USC Medical Center
Verified postcode
Los Angeles, United States
University of Southern California/Norris Cancer Center
Verified postcode
Los Angeles, United States
Memorial Medical Center
Verified postcode
Modesto, United States
Bay Area Tumor Institute CCOP
Verified postcode
Oakland, United States

Common questions

What is head and neck cancer?

Head and neck cancer is a term for cancers that develop in the mouth, throat, voice box, salivary glands, nose, or sinuses.

What is radiation therapy?

Radiation therapy uses high-energy rays to kill cancer cells and shrink tumours. In this study, a very precise method is used to target the cancer.

What is cetuximab?

Cetuximab is a medicine that specifically targets a protein on cancer cells, which can help stop them from growing and spreading.

Why is this study important?

This study aims to find out if adding cetuximab to radiation therapy can improve treatment success and survival for patients like you, helping to shape future cancer care.

How long will I be in the study?

Active treatment typically lasts several weeks, but you will be monitored with follow-up appointments for up to two years or more to track your progress.