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Chemotherapy + Radiation Therapy for Head and Neck Cancer
Study Summary
This trial is testing how well radiation therapy works in combination with different drugs after surgery to treat patients with high-risk stage III-IV 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.Side effects data
From 2014 Phase 4 trial • 32 Patients • NCT01301729Trial Design
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Who is running the clinical trial?
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- I am 18 years old or older.I agree to provide tissue samples for cancer analysis and have signed the study's consent form.I had a chest CT or CT/PET scan within the last 3 to 4 months.I have been mostly active and able to carry out all pre-disease activities until two weeks ago.My kidney function tests are within normal limits.I agree to use effective birth control during the study.I have received chemotherapy or anti-EGF therapy for my cancer.My cancer has spread beyond the lymph node capsule or was found at the edge of the removed tumor.I have been cancer-free for at least 3 years, except for non-melanoma skin cancer.My head or neck cancer is stage III or IV but hasn't spread far.I had head and neck scans within the last 84 days before my surgery.I agree to provide tissue samples for cancer analysis and have given my consent for the study.I do not have multiple primary cancers, except for bilateral tonsil cancer or a specific early-stage thyroid cancer.I am not pregnant and willing to use contraception if of childbearing potential.I have been examined by an ENT or head & neck surgeon before surgery.I've been examined by a cancer specialist within the last 84 days.I've had radiation in the same area where my current cancer is located.You can participate in the study even if you use a feeding tube.My cancer is a type of squamous cell carcinoma located in my head or neck.I had surgery to remove a high-risk cancer in my mouth or throat area within the last 63 days.
- Group 1: Arm 1 (IMRT, cisplatin)
- Group 2: Arm 2 (IMRT, docetaxel)
- Group 3: Arm 3 (IMRT, docetaxel, cetuximab)
- Group 4: Arm 4 (IMRT, cisplatin, atezolizumab)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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 objectives of this research?
"The primary outcome of this study is disease-free survival (DFS) over a 7-year period. Secondary outcomes include quality of life, patient-reported outcomes, and local-regional failure."
Do you know of any other times when Docetaxel has been trialed before?
"Docetaxel was first studied in 1997 at City of Hope Comprehensive Cancer Center. Since the initial study, there have been 2614 completed clinical trials. Currently, 1458 trials are recruiting patients, with a significant portion taking place in New york City."
Are there a lot of hospitals part of this research in city?
"One hundred different medical facilities are running this study, with locations in New york, Peoria, Saint Louis, and many other places. If you want to enroll in the study, try to choose a site near you to limit travel."
What is the most common reason that Docetaxel is given to patients?
"Docetaxel is a versatile chemotherapy medication, commonly used to treat metastatic bladder cancer as well as advanced testicular cancer, small cell lung cancer, and more."
Are there any patients that can still enroll in this trial?
"If you are reading this, it is likely that you are eligible for this study. This study is still looking for participants, even though it was originally posted on 2013-03-18."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
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