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Radiation Therapy + Cetuximab for Head and Neck Cancer
Study Summary
This trial is comparing radiation therapy alone to radiation therapy given with the drug cetuximab to see if it is more effective in treating patients who have had surgery for locally advanced head and neck cancer.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I had surgery to remove my cancer completely within the last 7 weeks and am at an 'intermediate' risk of it coming back.I had surgery to remove my tumor completely within the last 7 weeks, aiming for a cure.I have had a condition where my lymphocytes grow abnormally.I haven't had cancer in the last 5 years, except for skin cancer.I have been diagnosed with squamous cell carcinoma in the head or neck.I have a history of cancer.My cancer is in an early stage but may have spread to nearby lymph nodes.My cancer is a type of squamous cell carcinoma in the head or neck.My cancer is in an early stage but may have spread to nearby lymph nodes.
- Group 1: Arm II: IMRT plus cetuximab
- Group 2: Arm I: Intensity-Modulated Radiotherapy
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What are the most common conditions that intensity-modulated radiation therapy is used to improve?
"Intensity-modulated radiation therapy, a treatment that uses varying intensities of radiation to target cancer cells, can be used to treat hnscc, metastatic squamous cell carcinoma of the head and neck, as well as other conditions."
At how many different medical facilities is this trial being conducted?
"There are 100 active sites for this study, which can be found in Hanover, Mount Vernon, Albuquerque and many other places. If you choose to participate in the trial, it would be most convenient to select a location near you to minimize travel requirements."
Does this trial use any methods or technologies that have not been employed before?
"Research into intensity-modulated radiation therapy began in 2005 with a study of 154 sponsored by Bristol-Myers Squibb. After the first Phase 2 drug approval in 2005, there are now 136 ongoing studies involving 1362 cities and 51 countries."
Does intensity-modulated radiation therapy have any negative side effects?
"There is some evidence that intensity-modulated radiation therapy is effective, and it has been tested multiple times for safety, so it received a score of 3."
Are there other cases in which intensity-modulated radiation therapy has been used?
"At the moment, there are 136 ongoing clinical trials studying intensity-modulated radiation therapy. 30 of these trials are in Phase 3. Some of the studies for intensity-modulated radiation therapy are taking place in Dresden and Arizona, but there are 5679 locations running these kinds of trials altogether."
How many study subjects are taking part in this experiment?
"449 other trials for head neoplasms and 136 intensity-modulated radiation therapy studies are actively recruiting patients. The study you're inquiring about was last updated on 10/25/2022 and is not currently looking for new participants."
Are we still looking for volunteers for this experiment?
"The clinical trial detailed on clinicaltrials.gov is not seeking participants at this time. This study was first posted on November 1st, 2009 and was last edited on October 25th, 2022. There are 635 other trials that are actively recruiting patients."
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