~48 spots leftby Jan 2028

Reduced Radiation Therapy for Oropharyngeal Cancer

Recruiting in Palo Alto (17 mi)
+1 other location
DB
Overseen byDavid Brizel, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Duke University
Disqualifiers: Prior head/neck radiotherapy, Metastatic disease, others
No Placebo Group

Trial Summary

What is the purpose of this trial?

The purpose of this study is to use intra-treatment 18FDG-PET/CT during definitive radiation therapy for human papillomavirus (HPV)-related oropharyngeal cancer (OPC) as an imaging biomarker to identify and select patients with a favorable response for chemoradiation dose de-escalation. This study will prospectively evaluate the clinical outcomes for patients undergoing dose de-escalation.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of reduced radiation therapy for oropharyngeal cancer?

Research shows that oropharyngeal cancer linked to human papillomavirus (HPV) responds well to lower doses of radiation, maintaining high cure rates while reducing side effects. This is because HPV-positive cancers are more sensitive to radiation, allowing for effective treatment with less intensity.12345

Is reduced radiation therapy for oropharyngeal cancer safe?

Research shows that reducing the radiation dose for HPV-associated oropharyngeal cancer can lower side effects like severe mouth sores and swallowing difficulties, while still maintaining good survival rates. However, long-term follow-up is needed to confirm these findings.12567

How is reduced radiation therapy different from standard treatments for oropharyngeal cancer?

Reduced radiation therapy for oropharyngeal cancer involves using a lower dose of radiation compared to the standard treatment. This approach is being studied because it may reduce side effects and improve quality of life for patients, especially those with HPV-positive cancer, which tends to respond better to treatment.12358

Research Team

DB

David Brizel, MD

Principal Investigator

DUHS

Eligibility Criteria

This trial is for adults over 18 with HPV-related oropharyngeal cancer, confirmed by specific tests, who haven't had chemotherapy for their current diagnosis. They should be in good physical condition with minimal weight loss recently and have early to mid-stage cancer treatable with chemo.

Inclusion Criteria

I am fully active or can carry out light work.
I have lost less than 10% of my weight in the last 3 months.
My cancer is stage I-III and I will receive chemotherapy as standard care.
See 3 more

Exclusion Criteria

My cancer has spread to distant parts of my body.
I have not had any cancer except for non-melanoma skin cancer in the past 5 years.
I have had radiation therapy to my head or neck.
See 3 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive definitive radiation therapy with interim 18FDG-PET/CT imaging to assess response for potential dose de-escalation

7 weeks
Weekly visits for radiation therapy

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of acute and long-term adverse events

2 years

Treatment Details

Interventions

  • 18 fluorodeoxyglucose (FDG)-positron emission tomography (PET)-Computed Tomography (CT) (Other)
  • De-escalated radiation dose (Radiation)
  • Standard radiation dose (Radiation)
Trial OverviewThe study uses advanced imaging (FDG-PET/CT scans) during standard radiation therapy to see if some patients can receive lower doses of radiation safely. It aims to find out if reducing the dose after a positive response affects treatment outcomes.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Interim PET-CT with dose de-escalationExperimental Treatment2 Interventions
Participants will receive an interim PET-CT approximately 2 weeks into radiation therapy.
Group II: Interim PET-CT with standard radiationActive Control2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials
2,495
Recruited
5,912,000+
Mary E. Klotman profile image

Mary E. Klotman

Duke University

Chief Executive Officer since 2017

MD from Duke University School of Medicine

Michelle McMurry-Heath profile image

Michelle McMurry-Heath

Duke University

Chief Medical Officer since 2020

MD from Duke University School of Medicine

Findings from Research

Oropharyngeal carcinoma linked to human papillomavirus (HPV) is on the rise, but it has better treatment outcomes compared to traditional head and neck cancers, prompting a focus on treatment de-escalation strategies.
Current strategies for reducing treatment intensity include adjusting radiation doses, using selective nodal irradiation, and evaluating patient responses to induction chemotherapy, all aimed at minimizing side effects while preserving quality of life for younger, healthier patients.
Regional Radiation Therapy for Oropharyngeal Cancer in the HPV Era.Tam, M., Hu, K.[2019]
In a study of 759 patients with HPV-positive oropharyngeal squamous cell carcinoma, dose de-escalated radiation therapy (DDRT) did not result in inferior overall survival compared to standard dose radiation therapy (SDRT), with 3-year survival rates of 82.2% for DDRT and 79.3% for SDRT (P = 0.85).
The findings suggest that reducing radiation dose in HPV-positive OPSCC patients may be safe, as there was no significant difference in survival outcomes, indicating that ongoing randomized trials are needed to further explore this treatment approach.
Radiation therapy dose de-escalation compared to standard dose radiation therapy in definitive treatment of HPV-positive oropharyngeal squamous cell carcinoma.Gabani, P., Lin, AJ., Barnes, J., et al.[2020]
HPV-positive oropharyngeal squamous cell carcinoma has a better prognosis and is more sensitive to radiation than HPV-negative cancers, suggesting that lower radiation doses could be effective for treatment.
Recent studies indicate that de-escalated radiation therapy can maintain high cure rates and improve quality of life for selected patients, although challenges remain due to small sample sizes and variability in treatment protocols.
De-escalated radiation for human papillomavirus virus-related oropharyngeal cancer: evolving paradigms and future strategies.Chen, AM.[2023]

References

Regional Radiation Therapy for Oropharyngeal Cancer in the HPV Era. [2019]
Radiation therapy dose de-escalation compared to standard dose radiation therapy in definitive treatment of HPV-positive oropharyngeal squamous cell carcinoma. [2020]
Practice patterns and outcomes following radiation dose de-escalation for oropharyngeal cancer. [2020]
De-escalated radiation for human papillomavirus virus-related oropharyngeal cancer: evolving paradigms and future strategies. [2023]
[Treatment de-intensification strategies for HPV-driven oropharyngeal cancer: A short review]. [2020]
Phase II Evaluation of Aggressive Dose De-Escalation for Adjuvant Chemoradiotherapy in Human Papillomavirus-Associated Oropharynx Squamous Cell Carcinoma. [2021]
De-intensification of therapy in human papillomavirus associated oropharyngeal cancer: A systematic review of prospective trials. [2021]
Effectiveness of reduced- versus standard-dose radiotherapy on survival and radiation-associated toxicity in patients with human papillomavirus-associated oropharyngeal squamous cell carcinoma: a systematic review protocol. [2022]