Reduced Radiation Therapy for Oropharyngeal Cancer
Recruiting in Palo Alto (17 mi)
+1 other location
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?
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
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.
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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
De-escalated radiation dose is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as De-escalated radiation therapy for:
- HPV-associated oropharyngeal cancer
🇪🇺 Approved in European Union as De-escalated radiation therapy for:
- HPV-positive oropharyngeal squamous cell carcinoma
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Duke Raleigh HospitalRaleigh, NC
Duke University Medical CenterDurham, NC
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Who Is Running the Clinical Trial?
Duke UniversityLead Sponsor
References
Regional Radiation Therapy for Oropharyngeal Cancer in the HPV Era. [2019]Oropharyngeal carcinoma associated with the human papillomavirus is increasing in incidence and represents a unique head and neck disease with favorable treatment outcomes. This review evaluates the evolving role of radiotherapy in regional management with an overall goal of treatment de-escalation in the appropriate patient. Determining the optimal approach and selection factors for treatment de-escalation is under active investigation. Response to induction chemotherapy, refining adverse pathologic factors after a primary surgical approach, decreasing radiation dose with or without chemotherapy in the definitive or adjuvant settings as well as more selective nodal level irradiation all are current strategies for treatment de-escalation. This review details the likely changes in regional radiotherapy management for oropharyngeal carcinoma in the modern human papillomavirus era and discusses future approaches to patient selection with the goal of reducing toxicities while maintaining function preservation and quality of life in group of patients who are younger and healthier than traditional head and neck cancer patients.
Radiation therapy dose de-escalation compared to standard dose radiation therapy in definitive treatment of HPV-positive oropharyngeal squamous cell carcinoma. [2020]Despite existing evidence that human papillomavirus (HPV)-positive oropharyngeal squamous cell carcinoma (OPSCC) has a favorable prognosis compared to HPV-negative OPSCC, randomized studies have yet to report the effect of de-escalating radiation therapy (RT) dose for definitive treatment. The aim of this study was to assess the effectiveness of dose de-escalated RT (DDRT) vs. standard dose RT (SDRT) in patients with HPV-positive OPSCC.
Practice patterns and outcomes following radiation dose de-escalation for oropharyngeal cancer. [2020]Numerous trials are evaluating radiotherapy (RT) de-escalation for human papillomavirus (HPV)-mediated (HPV+) oropharyngeal squamous cell carcinoma (OPSCC). Herein, we evaluated the degree to which de-escalated RT is delivered in the United States, as well as comparative outcomes with full-dose RT as stratified for HPV status.
De-escalated radiation for human papillomavirus virus-related oropharyngeal cancer: evolving paradigms and future strategies. [2023]The incidence of human papillomavirus (HPV)-associated oropharyngeal squamous cell carcinoma has increased dramatically in recent years reaching epidemic-like proportions. Data has emerged not only showing that these cancers are a unique entity with distinct molecular characteristics but that they also have a significantly improved prognosis as a result of their exquisite radiosensitivity compared to their HPV-negative counterparts. This, it has been increasingly suggested that these tumors can be targeted with de-escalated approaches using reduced doses of radiation. The overriding goal of de-escalation is to maintain the high cure and survival rates associated with traditional approaches while reducing the incidence of both short- and long-term toxicity. Although the exact reason for the improved radiosensitivity of HPV-positive oropharyngeal carcinoma is unclear, prospective studies have now been published demonstrating that de-escalated radiation can successfully maintain the high rates of cure and preserve quality of life for appropriately selected patients with this disease. However, these studies have been complicated by such factors as the relatively limited sample sizes, as well as the variability in treatment, inclusion criteria, and follow-up. As the data continues to mature on de-escalation, it is unquestionable that treatment paradigms for this disease will evolve. The ongoing quest to define a standard regimen comprises the subject of this review.
[Treatment de-intensification strategies for HPV-driven oropharyngeal cancer: A short review]. [2020]The incidence of oropharyngeal cancer induced by human papillomavirus (HPV) infection is steadily increasing in developed countries. These tumors are more chemoradiosensitive and have a better prognosis than HPV-negative one. In addition, they occur in younger and better-off patients with longer life expectancy. Current radiotherapy and chemotherapy protocols are currently being questioned as they may expose HPV-positive patients to excessive treatment and unnecessary toxic effects. Less intensive treatment regimens could possibly achieve similar efficacy with lower toxicity and improved quality of life. The aim of this work was to summarize the knowledge on these tumors and their implications for radiation oncologists. In this update, we will discuss ongoing de-escalation trials and highlight the issues raised by these studies. We will also comment on the results of recently published de-intensification studies. Three main strategies are analyzed in the present article: the de-escalation of the drug associated with radiotherapy, the de-escalation of the radiotherapy dose (in concomitant chemoradiotherapy, after induction chemotherapy, in a postoperative setting) and de-escalation of radiation target volumes. Our findings ultimately indicate that clinicians should not change the management of oropharyngeal cancer patients outside of clinical trials.
Phase II Evaluation of Aggressive Dose De-Escalation for Adjuvant Chemoradiotherapy in Human Papillomavirus-Associated Oropharynx Squamous Cell Carcinoma. [2021]The purpose of this study was to determine if dose de-escalation from 60 to 66 Gy to 30 to 36 Gy of adjuvant radiotherapy (RT) for selected patients with human papillomavirus-associated oropharyngeal squamous cell carcinoma could maintain historical rates for disease control while reducing toxicity and preserving swallow function and quality of life (QOL).
De-intensification of therapy in human papillomavirus associated oropharyngeal cancer: A systematic review of prospective trials. [2021]Numerous trials have been launched over the prior decade examining the safety and efficacy of therapy de-escalation in human papillomavirus (HPV)-associated oropharyngeal cancer (OPC). Because no summative assessment of these prospective trials exists to date, we systematically reviewed the outcomes and toxicities associated with therapy de-intensification for this population. PRISMA-guided systematic PubMed searches (along with articles known to the authors and references thereof) were performed for prospective studies reporting clinical outcomes and/or toxicities of de-intensified RT and/or systemic therapy (with or without surgery), exclusively for HPV-associated OPC. Ten prospective studies were analyzed. Performing a meta-analysis was not entirely possible owing to the heterogeneity of treatment paradigms and the lack of >2 studies for most paradigms; however, because just one paradigm (induction chemotherapy followed by reduced-dose RT and/or systemic therapy) had 4 associated articles, an exploratory meta-analysis was conducted for that subset. Two trials of dose-reduced concurrent chemoradiotherapy (60 Gy/weekly cisplatin) demonstrated 3-year distant metastasis-free survival and overall survival (OS) ranging from 91 to 100% and 95%, respectively; acute grade 3+ mucositis and dysphagia occurred in 33-35% and 21-39%, respectively. In the four trials of induction chemotherapy (platinum/taxane-based) followed by dose-reduced RT, 2-year progression-free and OS ranged from 80 to 95% and 83 to 98%, respectively; acute grade 3+ dysphagia, dermatitis, and mucositis ranged from 9 to 15%, 7 to 20%, and 9 to 30% (excluding one outlier), respectively. For these four trials, the exploratory meta-analysis showed a pooled 2-year PFS and OS of 89% (95% confidence interval, 80-96%) and 96% (92-99%). The pooled rates of grade ≥3 dysphagia, dermatitis, and mucositis were 13% (7-19%), 9% (5-14%), and 28% (9-53%). However, there was significant heterogeneity in the 2-year PFS (I2 = 57%, p = 0.07) and grade ≥3 mucositis (I2 90%, p < 0.01). Next, both randomized trials which replaced concurrent tri-weekly cisplatin with weekly cetuximab illustrated superior outcomes with the former. Lastly, two remaining trials (one using functional imaging to guide reduced-dose RT, and another examining reduced-dose postoperative RT) also showed satisfactory outcomes and toxicities. Taken together, dose-reduced chemoradiotherapy (with or without induction chemotherapy for patient/biology selection purposes) seems to be a promising de-escalation strategy for HPV-associated OPC, although replacement of concurrent cisplatin by cetuximab is not recommended. Long-term follow-up is required for firmer conclusions.
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]The objective of this review is to investigate overall survival in patients with human papillomavirus positive oropharyngeal squamous cell carcinoma (HPV+ OPSCC) comparing standard- versus reduced-dose radiotherapy.