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Adjuvant Radiotherapy for Head and Neck Cancer
N/A
Waitlist Available
Led By Daniel J. Ma, M.D.
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Clinical stage T0 N1-N3 and confirmed pathologic stage T0 N1-N2 M0 (American Joint Committee on Cancer [AJCC] 8th edition) with one of the following risk factors: Lymph node >= 3 cm, >= 2 positive lymph nodes, Presence of extracapsular extension, > 1 nodal level involved, Absence of distant metastases on standard diagnostic workup, prior to registration (chest computed tomography [CT], chest x-ray [CXR], or positron emission tomography [PET]/CT)
Histological confirmation of human papillomavirus (HPV)+ squamous cell carcinoma as defined by neck node pathology. HPV positivity will be defined as positive staining for p16 and HPV deoxyribonucleic acid (DNA) in situ hybridization (ISH). (If discordant, ribonucleic acid [RNA] ISH will be run for confirmatory testing)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is testing if radiation to the neck only for tumors that couldn't be found during surgery will still be effective while reducing side effects from treatment.
Who is the study for?
This trial is for adults with HPV+ head and neck cancer where the primary tumor site is unknown, who've had specific surgical evaluations and are eligible for IMPT or IMRT radiotherapy. They must have no distant metastases, be able to complete questionnaires, provide consent, and follow up at the institution. Pregnant or nursing women, those unwilling to use contraception, HIV patients, individuals with certain autoimmune diseases or a history of radiation therapy in the area are excluded.Check my eligibility
What is being tested?
The study tests if mucosal sparing adjuvant radiotherapy after surgery can control disease while reducing side effects compared to traditional methods. It involves medical chart reviews, patient observation, quality-of-life assessments through questionnaires administered before and after treatment.See study design
What are the potential side effects?
While not explicitly listed in the provided information, typical side effects from radiotherapy may include skin irritation at the treatment site, fatigue, dry mouth or throat issues due to inflammation of mucous membranes (mucositis), difficulty swallowing (dysphagia), and potential changes in taste.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is in the lymph nodes but hasn't spread to distant parts of my body.
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My cancer is HPV+ squamous cell carcinoma confirmed by tests.
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My breast cancer is in the early stages but has spread to nearby lymph nodes.
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I have a lymph node that is 3 cm or larger.
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I have 2 or more lymph nodes that tested positive for cancer.
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My cancer has spread outside the organ's capsule.
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More than one group of my lymph nodes is affected.
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My cancer has not spread to distant parts of my body according to recent scans.
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My ENT oncologist says I can have surgery through my mouth and neck.
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I am fully active or restricted in physically strenuous activity but can do light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Primary local recurrence
Secondary outcome measures
Change in swallowing function
Distant metastasis rates
Incidence of acute adverse events
+4 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (follow-up, observation)Experimental Treatment4 Interventions
Patients who have recurrence or progression during treatment or observation have medical charts are reviewed every 6 months for 5 years. Patients who complete adjuvant treatment are followed for observation 3 days after radiation therapy, 1 month after radiation therapy, every 3 months after radiation therapy for 2 years, every 6 months for 1 year, and then annually for 2 years.
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,207 Previous Clinical Trials
3,767,138 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,658 Previous Clinical Trials
40,924,487 Total Patients Enrolled
Daniel J. Ma, M.D.Principal InvestigatorMayo Clinic in Rochester
1 Previous Clinical Trials
204 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently breastfeeding.I am not taking any experimental drugs for my cancer.My cancer has spread outside the organ's capsule.I can have a special scan to check for hidden cancer in my head or neck.My cancer has not spread to distant parts of my body according to recent scans.I do not have any serious illnesses or social situations that would stop me from following the study's requirements.I have 2 or more lymph nodes that tested positive for cancer.My cancer is in the lymph nodes but hasn't spread to distant parts of my body.My cancer is HPV+ squamous cell carcinoma confirmed by tests.My breast cancer is in the early stages but has spread to nearby lymph nodes.I am fully active or restricted in physically strenuous activity but can do light work.My insurance doesn't cover IMPT, so I'll receive standard IMRT treatment.I am eligible for a specific radiation therapy for throat cancer.I am eligible for additional cancer treatment after my primary treatment.I have undergone thorough surgical examination of my throat area, including removal of specific parts if needed.My kidney function, measured by creatinine levels or clearance, is within the required range.I am not willing to use birth control.I have a history of conditions like scleroderma, rheumatoid arthritis, lupus, or Sjogren's.I have had radiation therapy on the cancer site before.More than one group of my lymph nodes is affected.I am aware the study drug may affect my DNA and could harm a pregnancy.I haven't had cancer, except for certain types, in the last 5 years and am not currently receiving treatment for any.My ENT oncologist says I can have surgery through my mouth and neck.I have a lymph node that is 3 cm or larger.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (follow-up, observation)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the scope of enrolment in this medical trial?
"Affirmative. Clinicaltrial.gov confirms that this experiment, which was first announced on October 6th 2020, is actively recruiting participants. 45 patients will be accepted at 4 medical facilities across the country."
Answered by AI
Are there currently any opportunities for individuals to partake in this experiment?
"Affirmative. Clinicaltrials.gov data indicates that this investigation, initially posted on October 6th 2020 is presently open for enrollment. 45 participants are required across 4 sites to complete the study."
Answered by AI
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