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ctHPVDNA in HPV Positive Squamous Cell Carcinoma of the Oropharynx

ConditionsSquamous Cell Carcinoma of OropharynxHPV Positive CancerThroat CancerTonsil Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIndiana University

About this trial

This study is a prospective phase II trial, designed to assess the efficacy and feasibility of adjuvant treatment deintensification guided by ctHPVDNA levels for patients with HPV+OPSCC who undergo transoral surgery and neck dissection.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subjects ≥ 18 years old at the time of informed consent.

Ability to provide written informed consent and HIPAA authorization.

Eastern Cooperative Oncology Group (ECOG) performance status 0-2.

Primary tumor of the oropharynx (palatine tonsil, tongue base, soft palate, lateral or posterior walls of oropharynx).

Disqualifiers

Serious medical condition preventing general anesthesia for surgery.

History of previous head and neck radiation or previous head and neck cancer within 3 years.

Distant metastatic disease present.

Subjects with synchronous HPV+ oropharynx primaries

Trial design

Design model

Sequential

Treatments tested in this trial

  • NavDx

    Diagnostic test

    NavDx is a clinically validated blood test to detect circulating tumor HPV DNA (ctHPVDNA). In this study, ctHPVDNA results, in conjuction with specimen analysis, will be used to assign post-surgical adjuvant treatment.

  • Adjuvant Radiation 30 Gray

    Radiation

    If undetectable postoperative ctHPVDNA levels and five or more positive nodes, or confirmed extranodal extension (ENE) (greater than 2 mm) deintensified radiation treatment of 30 gray.

  • Adjuvant Radiation 40 Gray

    Radiation

    If detectable postoperative ctHPVDNA, then reimage to evaluate for potentially operable disease, followed by appropriate surgery as indicated. If surgery is performed, repeat ctHPVDNA levels will be checked, and if then negative, subject will be placed in observation if N0 or N1 disease, and 30 Gy of radiation if N2 disease on final pathologic staging. If repeat ctHPVDNA level is positive, or shows no obvious operable disease, then subject will undergo 40 Gy of radiation.

Treatment groups

120 Participants
are divided into 3 treatment groups
Group A: ObservationExperimental treatment 1 intervention
Group B: Adjuvant Radiation 30 GrayExperimental treatment 2 interventions
Group C: Adjuvant Radiation 40 GrayExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Disease Free Survival

Time from surgery to first disease recurrence or death from any cause

Time frame
Up to 24 months post initial surgery

Secondary outcomes

1

Local-reginal Control

Number of subjects with no recurrence at primary oropharyngeal site or in the neck nodal basins

Time frame
Up to 24 months post initial surgery
2

Overall Survival

Time from surgery to death from any cause

Time frame
Up to 24 months post initial surgery
3

Distant metastasis rates

Assessed by tissue diagnosis or radiographically of recurrent disease at sites away from the primary tumor and neck nodal basins

Time frame
Up to 24 months post initial surgery
4

Adverse Events

Number of subjects that experience adverse events, grades 1-5, as assessed by the National Cancer Institute Common Toxicity Criteria (NCI-CTCAE) version 5.0

Time frame
up to 6 months post initial surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Indiana University

Lead sponsor

Source ClinicalTrials.gov
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