HPV DNA-Guided Radiotherapy De-intensification of Head and Neck Squamous Cell Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Virginia
About this trial
The study will evaluate the safety and effectiveness of a lower than standard dose of radiation for definitive or adjuvant treatment of head and neck squamous cell carcinomas.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for the duration of the study
Male or female, ≥ 18 years of age
Pathologically proven diagnosis of squamous cell carcinoma of the oropharynx of any AJCC 8th edition stage.
Disqualifiers
Evidence of distant metastatic disease
Prior history of radiotherapy to the head and/or neck
Had surgery for oropharyngeal cancer within 8 months of enrollment unless it was an incomplete oncologic surgery. Participant is eligible if the gross tumor was not completely removed.
Diagnosis of T3-4 and/or N+ disease with no plans to receive concurrent chemotherapy.
Trial design
Design model
Parallel
Treatments tested in this trial
Radiation Therapy
RadiationExternal Beam Radiation to Head and Neck
Treatment groups
90 Participants
are divided into 4 treatment groupsGroup A: Reduce Dose without Concurrent Chemotherapy Non- Rapid ResponderExperimental treatment 1 intervention
Group B: Reduce Dose with Concurrent Chemotherapy Non-Rapid ResponderExperimental treatment 1 intervention
Group C: Reduce Dose without Concurrent Chemotherapy Rapid ResponderExperimental treatment 1 intervention
Group D: Reduce Dose with Concurrent Chemotherapy Rapid ResponderExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
To assess the disease control of participants who receive dose and volume-de-escalated radiotherapy to the neck, guided by treatment response through circulating tumor-modified HPV DNA testing
Incidence of disease free survival as measured by circulating HPV on Nav Dx blood tests.
Time frame
up to 2 years after radiotherapySecondary outcomes
1
To assess safety for treatment with reduced dose and volume-de-escalated radiotherapy to the neck
Incidence of grade 3 (or greater) adverse events as defined by the CTCAE v5.0
Time frame
Evaluated through 6 months and 1 year post- radiation.2
To estimate quality of life of participants who receive reduced dose and volume-de-escalated radiotherapy to the neck
Quality of life as determined by the EORTC H\&N35. Questions are scaled from 1-4 with 1 meaning the symptom/problem was not experienced and 4 meaning the symptom/problem was experienced at a high level.
Time frame
up to 2 years after radiotherapy3
To estimate quality of life of participants who receive reduced dose and volume-de-escalated radiotherapy to the neck
Quality of life as determined by the EORTC QLQ-C30. Majority of questions are scaled from 1-4 with 1 meaning the symptom/problem was not experienced and 4 meaning the symptom/problem was experienced at a high level. Two questions are scaled from 1-7 with 1 meaning very poor (worse outcome) and 7 meaning excellent (best outcome).
Time frame
up to 2 years after radiotherapyOther outcomes
1
To estimate long-term survival for participants treated with dose and volume-de-escalated radiotherapy to the neck
Overall survival
Time frame
up to 5 years after radiotherapy2
To estimate the relationship between baseline lymphocyte counts and disease progression outcomes.
Baseline lymphocyte counts from CBC with Differential blood test
Time frame
up to 2 years after radiotherapy3
To estimate the relationship between baseline lymphocyte counts and disease progression
Occurrence of disease progression
Time frame
up to 2 years after radiotherapySponsors and contacts
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Source ClinicalTrials.gov