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Radiation

Personalized Radiation Therapy for Throat Cancer

Phase 3
Recruiting
Led By Nancy Lee, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must test positive for both p16 expression and mRNA HPV in situ hybridization
Pathologically proven diagnosis of HPV associated squamous cell carcinoma of the oropharynx or squamous cell carcinoma with an unknown primary
Must not have
No particle therapy
Patients with prior head and neck radiation therapy with >30% overlap with current fields
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Summary

This trial is testing if a personalized approach to chemoradiation therapy, including a lower dose of radiation, is as effective as the standard treatment for people with HPV-positive throat cancer. The study will

Who is the study for?
This trial is for individuals with HPV-positive throat cancer. Participants should be suitable for chemoradiation therapy and willing to undergo personalized treatment, which may involve a lower radiation dose. Specific eligibility criteria are not provided, but typically include factors like age, health status, and cancer stage.
What is being tested?
The study compares personalized chemoradiation therapy (potentially lower radiation doses) against standard chemoradiation in treating HPV-positive throat cancer. It aims to determine if the personalized approach is as effective while causing fewer side effects and impacting quality of life differently.
What are the potential side effects?
While specific side effects are not listed, typical ones from chemoradiation can include fatigue, skin reactions at the radiation site, difficulty swallowing, dry mouth or thickened saliva due to damage to salivary glands, nausea or vomiting.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer tests positive for p16 and HPV.
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My cancer is HPV-related or squamous cell carcinoma of the throat.
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My breast cancer is in an early stage and hasn't spread far.
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I am fully active or able to carry out light work.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not undergone particle therapy.
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I had radiation therapy on my head/neck that overlaps significantly with my current treatment area.
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I cannot take cisplatin or carboplatin/5-FU due to health reasons.
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My cancer is near the muscles at the front of my tongue.
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I have cancer in areas other than the oropharynx.
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I have received chemotherapy for my current cancer.
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I do not have severe heart problems, infections, COPD flare-ups, or liver issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
overall survival

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Personalized Chemoradiation TherapyExperimental Treatment3 Interventions
Patient without evidence of hypoxia will receive 30Gy in 2Gy per fraction. Concurrent chemotherapy will be given as per guidelines. After completion of chemotherapy and radiation therapy, a 4 month (+/- 4 weeks) posttreatment standard FDG PET/CT scan will be performed and if there is persistent disease, standard neck dissection will be performed. Further standard of care will be given pending pathologic findings.1. Hypoxia negative: The entire target volume which includes GTV and CTV will receive 30Gy in 2 Gy per fraction over 15 days (PTV30). 2. Hypoxia positive (same as the standard of care): The CTV will receive 50Gy in 2Gy per fraction over 25 days. This is name PTV50 and will receive 50Gy in 2Gy per fraction over 25 days. The GTV will receive an additional boost of 20Gy in 2 Gy per fraction so that the total PTV70 dose is 70Gy.
Group II: Standard Chemoradiation TherapyActive Control3 Interventions
Patient will receive 70Gy in 2Gy per fraction regardless of hypoxia status. Concurrent chemotherapy will be given as per guidelines. After completion of chemotherapy and radiation therapy, a 4 month (+/- 4 weeks) posttreatment standard FDG PET/CT scan will be performed and if there is persistent disease, standard neck dissection will be performed. Further standard of care will be given pending pathologic findings.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Chemoradiation
2006
Completed Phase 3
~990

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,956 Previous Clinical Trials
595,265 Total Patients Enrolled
Nancy Lee, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
13 Previous Clinical Trials
2,108 Total Patients Enrolled
~194 spots leftby Aug 2027
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