Oropharyngeal Cancer Clinical Trial
Official title:
HYHOPE: Phase I Study of De-intensified Hypofractionated Radiation Therapy for Human Papilloma Virus-associated Oropharynx Cancer
This is a single arm Phase I study of de-intensified hypofractionated radiation therapy for favorable human papilloma virus-associated oropharynx cancer. It will evaluate the tolerability of a de-intensified hypofractionated radiation therapy regimen completed in 3 weeks (with equivalent biologically effective dose to 60 Gy in 30 fractions) with concurrent weekly cisplatin.
Standard of care radiation therapy (RT) for head and neck squamous cell carcinoma (HNSCC) involves conventional fractionation delivered over a course of 7 weeks. Although hypofractionated RT (HFRT) delivering higher dose of RT each day over a shorter overall treatment time has been studied and adopted as standard of care in many disease sites including breast and prostate cancers, data on HFRT in HNSCC is limited. There is a strong radiobiological rationale for HFRT for HNSCC to decrease the overall treatment time and thus the effects of accelerated repopulation in this disease entity. In addition, if similar outcomes can be achieved with a reduced number of fractions, cost effectiveness of care can be improved while minimizing the disruption to the patient's personal and professional lives. A substantial decrease in treatment time may improve compliance and financial toxicity associated with the patient's oncologic treatment. The global COVID-19 pandemic is highlighting the health risk to society at large of having no viable alternative to a 7 week daily RT course for HNSCC, especially in the setting of compromised immune systems associated with concurrent chemotherapy frequently used in this patient population. Thus, the study of HFRT for HNSCC is both timely and potentially paradigm changing for practices across the United States. The incidence of human papilloma virus (HPV)-associated oropharynx cancer is increasing in the United States, now accounting for 70-80% of all oropharynx cancers. It has a favorable prognosis vs. non-HPV-associated cancers and studies are ongoing to determine the best strategy to de-intensified therapy while maintaining good oncologic outcomes. The purpose of this single-arm Phase I study is to assess the tolerability and signal for efficacy of de-intensified HFRT for favorable HPV-associated oropharynx cancer. De-intensification will be achieved in two ways. First, the equivalent biologically effective dose (BED) of HFRT used on trial will be 60 Gy of conventionally fractionationated RT (vs. the current standard of care of 70 Gy). Second, the elective nodal volume irradiated will be limited to involved nodal levels and one immediately adjacent level (vs. the current standard of care of entire bilateral neck nodal regions). Patients will complete RT in 15 fractions (3 weeks) with concurrent weekly cisplatin on dose level 0. If a 3-week regimen is not well-tolerated, a 20 fraction regimen will be used on dose level -1. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT03656133 -
Use of a Proliferation Saturation Index to Determine Personalized Radiotherapy for HPV + Oropharyngeal Cancers
|
N/A | |
Terminated |
NCT02225496 -
Robotic Surgery for Oropharyngeal Squamous Cell Carcinoma
|
Phase 2 | |
Withdrawn |
NCT01767961 -
Modified Barium Swallow in Measuring Swallowing Function After Surgery in Patients With Oropharyngeal Cancer
|
N/A | |
Completed |
NCT01695122 -
Valproic Acid and Platinum-based Chemoradiation in Locally Advanced Head and Neck Squamous Cell Carcinoma
|
Phase 2 | |
Completed |
NCT01435252 -
A Phase II Study In Patients With Advanced Head And Neck Cancer Of Standard Chemoradiation And Add-On Cetuximab
|
Phase 2 | |
Recruiting |
NCT04708470 -
A Phase I/II Study of Combination Immunotherapy for Advanced Cancers Including HPV-Associated Malignancies, Small Bowel, and Colon Cancers
|
Phase 1/Phase 2 | |
Withdrawn |
NCT00951470 -
Complete Decongestive Therapy (CDT) for Treatment of Head and Neck Lymphedema
|
N/A | |
Completed |
NCT01358097 -
Role of Immune Activation in Response of Head and Neck Squamous Cell Carcinoma to Therapy
|
N/A | |
Completed |
NCT00964977 -
Effectiveness of Adjuvant Radiotherapy in Small Oropharyngeal Squamous Cell Cancer and Single Lymph Node Metastasis.
|
Phase 3 | |
Completed |
NCT01342978 -
Human Papillomavirus (HPV) Oral Transmission Study in Partners Over Time
|
N/A | |
Recruiting |
NCT05363709 -
BALSTILIMAB on Viral Clearance in HPV+ Oropharyngeal Cancer Patients
|
Phase 2 | |
Completed |
NCT02280811 -
T Cell Receptor Immunotherapy Targeting HPV-16 E6 for HPV-Associated Cancers
|
Phase 2 | |
Active, not recruiting |
NCT03777384 -
EValuating the Safety Of De-escaLated Head and Neck Irradiation in HPV positivE Oropharynx Cancer in Non-smokers/Minimal Smokers
|
||
Active, not recruiting |
NCT03729518 -
TORS De-Intensification Protocol Version 2.0: Dose and Volume Reduction in the Neck
|
N/A | |
Recruiting |
NCT06121102 -
Standard Pulsed Radiofrequency Versus Supervoltage Pulsed Radiofrequency Glossopharyngeal Nerve in Oropharyngeal Cancer Pain
|
N/A | |
Recruiting |
NCT02984410 -
Study Assessing The "Best of" Radiotherapy vs the "Best of" Surgery in Patients With Oropharyngeal Carcinoma
|
N/A | |
Recruiting |
NCT02960724 -
uPAR PET/CT for Staging Advanced and Localised Oral and Oropharyngeal Cancer
|
Phase 2 | |
Completed |
NCT02934724 -
Impact of HPV Vaccine On The Prevalence Of HPV In Norway
|
||
Withdrawn |
NCT00928161 -
Reflux Disease in Head and Neck Cancer Patients Undergoing Radiation Therapy
|
N/A | |
Recruiting |
NCT02012699 -
Integrated Cancer Repository for Cancer Research
|