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Personalized Cancer Treatment Intensity for Oropharyngeal Cancer

Phase 2
Waitlist Available
Led By Andrew Wang, MD
Research Sponsored by UNC Lineberger Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
T0-3, N0 to N2c, M0 squamous cell carcinoma of the oropharynx
Adequate renal and hepatic function within 4 weeks prior to treatment, defined as follows: Serum creatinine < 2.0 mg/dl; Total bilirubin < 2 x the institutional ULN; AST or ALT < 3 x the institutional ULN
Timeline
Screening 3 weeks
Treatment Varies
Follow Up two years after completion of the treatment
Awards & highlights

Study Summary

This trial is testing whether a person's genes can predict how well they'll respond to a less intense cancer treatment plan.

Who is the study for?
This trial is for adults with HPV-related Oropharyngeal Squamous Cell Carcinoma who have a history of smoking more than 10 pack years. They must be in good physical condition, have no prior head and neck cancer or certain severe illnesses, not be on specific rheumatoid drugs, and able to follow the treatment plan.Check my eligibility
What is being tested?
The study tests if genomic risk-stratification can guide the intensity of radiotherapy and chemotherapy (Cisplatin) for patients based on their p53 mutation status and smoking history. It compares de-intensified vs standard treatments to see if they affect survival without disease progression.See study design
What are the potential side effects?
Potential side effects include skin reactions from radiation, nausea from chemotherapy, fatigue, hearing loss due to Cisplatin use, dry mouth or difficulty swallowing post-radiotherapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is in the oropharynx and hasn't spread far.
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My kidney and liver tests are within normal limits.
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My cancer is squamous cell and tests positive for HPV or p16.
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I am fully active or can carry out light work.

Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression Free Survival (PFS)
Secondary outcome measures
Distant Metastasis Free Survival
Local Control Rate
Local-regional Control Rate
+6 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Radiotherapy and/or chemotherapy.Experimental Treatment3 Interventions
Subjects with Oropharyngeal Squamous Cell Carcinoma receiving radiotherapy and/or chemotherapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Intensity Modulated Radiotherapy (IMRT)
2011
Completed Phase 2
~300
Cisplatin (or alternative)
2016
Completed Phase 2
~200
Assessment for surgical evaluation
2016
Completed Phase 2
~200

Find a Location

Who is running the clinical trial?

UNC Lineberger Comprehensive Cancer CenterLead Sponsor
353 Previous Clinical Trials
90,217 Total Patients Enrolled
Andrew Wang, MDPrincipal InvestigatorUniversity of North Carolina at Chapel Hill, Department of Radiation Oncology
3 Previous Clinical Trials
196 Total Patients Enrolled
Wendell Gray Yarbrough, MDPrincipal InvestigatorUniversity of North Carolina at Chapel Hill, Department of Radiation Oncology

Media Library

Intensity Modulated Radiotherapy (IMRT) - deintensified Clinical Trial Eligibility Overview. Trial Name: NCT03077243 — Phase 2
Head and Neck Cancers Research Study Groups: Radiotherapy and/or chemotherapy.
Head and Neck Cancers Clinical Trial 2023: Intensity Modulated Radiotherapy (IMRT) - deintensified Highlights & Side Effects. Trial Name: NCT03077243 — Phase 2
Intensity Modulated Radiotherapy (IMRT) - deintensified 2023 Treatment Timeline for Medical Study. Trial Name: NCT03077243 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are some of the risks associated with Intensity Modulated Radiotherapy (IMRT) - deintensified?

"Intensity Modulated Radiotherapy (IMRT) - deintensified is currently in Phase 2 of clinical trials. While there is supportive data for safety, there remains a lack of evidence regarding efficacy. Our team has rated it as a 2 on our 3-point scale."

Answered by AI

Could you please explain what Intensity Modulated Radiotherapy (IMRT) - deintensified is typically used for?

"While most commonly used to treat advanced ovarian cancer, Intensity Modulated Radiotherapy (IMRT) - deintensified can also be used as a last resort for patients with refractory testicular cancer and advance directives."

Answered by AI

Are there any current vacancies for this experiment?

"Unfortunately, this trial is not currently enrolling patients. Although, it's worth noting that the study was last updated on January 25th, 2022. There are 5257 trials actively seeking cancer of oropharnyx participants and 714 for Intensity Modulated Radiotherapy (IMRT) - deintensified if you're looking for other options."

Answered by AI

How many different medical clinics are participating in this study?

"The trial is being conducted at 4 sites. 3 of the locations are in North carolina (Gainesville, Chapel Hill and Raleigh) with 1 other site in an undisclosed location. If you enroll, choose the nearest option to limit travel."

Answered by AI

Can you please provide context for this IMRT - deintensified clinical trial in relation to other similar trials?

"At this time, there are 714 ongoing clinical trials investigating Intensity Modulated Radiotherapy (IMRT) - deintensified. Of these trials, 284 are in Phase 3. Many of the clinical trials for Intensity Modulated Radiotherapy (IMRT) - deintensified are based in Shanghai, but there are 43259 locations operating studies for Intensity Modulated Radiotherapy (IMRT) - deintensified worldwide."

Answered by AI
Recent research and studies
Journal of Clinical OncologyJournal
Plasma Circulating Tumor HPV DNA for the Surveillance of Cancer Recurrence in Hpv-associated Oropharyngeal Cancer
Chera, Bhishamjit S., Sunil Kumar, Colette Shen, Robert Amdur, Roi Dagan, Rebecca Green, Emily Goldman, et al.. 2020. “Plasma Circulating Tumor HPV DNA for the Surveillance of Cancer Recurrence in Hpv-associated Oropharyngeal Cancer”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.19.02444.
clinicaltrials.govStudy
P53 Mutational Status and cf HPV DNA for the Management of HPV-associated OPSCC
2016. "P53 Mutational Status and cf HPV DNA for the Management of HPV-associated OPSCC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03077243.
~23 spots leftby May 2025
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