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Risk Adapted De-Intensification of Radio-Chemotherapy for Oropharyngeal Squamous Cell Carcinoma

ConditionOropharyngeal Squamous Cell Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Florida

About this trial

This study builds on the results of several prior studies that we have been involved with to test the hypothesis that Risk-Adapted De-Intensification of Radiation Therapy and chemotherapy based on HPV subtype, plasma circulating free HPV DNA (cfHPV DNA) level, and cfHPV DNA clearance rate produces Local-Regional Control rates that are similar to what has been achieved with more aggressive therapy in patients with Favorable Prognosis Oropharyngeal Squamous Cell Carcinoma (OPSCC).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥ 18 years of age (no upper age limit)

T0-3, N0 to N2, M0 squamous cell carcinoma of the oropharynx by AJCC 8th Edition staging. If T0 the adenopathy must be predominantly in Level 2.

Tissue diagnosis of HPV and/or p16 positivity from the primary site or an associated lymph node.

Radiologic confirmation of the absence of lung metastasis within 12 weeks prior to treatment; at a minimum, CT of the chest is required. PET-CT is acceptable.

Disqualifiers

Prior radiotherapy for oropharyngeal squamous cell carcinoma (OPSCC) OR to the head and neck that, if combined with the protocol therapy, is deemed likely to compromise critical organs at risk in the opinion of the investigator.

Prior cancer within the last 10 years.

Prior surgery with curative intent for this OPSCC.

Patients who have undergone tonsillectomy for diagnosis or excisional biopsy of a neck node for diagnosis are eligible provided there is "gross" cancer present at the primary site or in the neck at the start of radiation therapy on this protocol with "gross" defined as visible on an imaging study.

Trial design

Design model

Single group

Treatments tested in this trial

  • Radiation therapy

    Radiation

    Participants will receive either 70 gray (Gy), 60 Gy, or 50 Gy of radiation based on the following criteria: 70 Gy: Pretreatment level of plasma circulating free HPV DNA (cfHPV DNA) ≤ 3 copies/mL 60 Gy: Tumor tissue positive for HPV subtype other than 16 OR Pretreatment level of cfHPV DNA 4-99 copies/mL OR Pretreatment level of cfHPV DNA ≥ 100 copies/mL AND \<95% decrease in the level cfHPV DNA by the end of week 4 of radiation therapy 50 Gy: Tumor tissue positive for HPV subtype 16, pretreatment level of cfHPV DNA ≥ 100 copies/mL, AND ≥ 95% decrease in the level cfHPV DNA by the end of week 4 of radiation therapy

  • Cisplatin

    Drug

    All participants will receive 40 mg/m2 of cisplatin intravenously over 60 minutes weekly during radiation therapy. If cisplatin is not recommended by the treating medical oncologist or is not tolerated, it is permissible to switch to an alternative chemotherapy regimen per institutional practice, but chemotherapy should not be discontinued unless mandated by the patient's condition.

Treatment groups

250 Participants
are divided into 1 treatment group
Group A: Chemo-radiotherapyExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Local-Regional Control Rate

Determine the Local-Regional Control Rate, defined as the absence of recurrence of OPSCC at the primary site or in a neck node that was included in a radiation therapy target volume

Time frame
2 years

Secondary outcomes

1

Local Control Rate

Determine the local control rate, defined as as the absence of recurrence of OPSCC at the primary site

Time frame
2 years
2

Regional Control Rate

Determine the regional control rate, defined as the absence of recurrence in a neck node

Time frame
2 years
3

Disease-Free Survival

Determine the disease-free survival, defined as the time from the first day of radiation to the date of first recurrence (local, regional, or distant)

Time frame
2 years
4

Distant Metastasis-Free Survival

Determine the distant metastasis-free survival, defined as the time from the first day of radiation to the date distant metastases are confirmed

Time frame
2 years

Other outcomes

Sponsors and contacts

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

University of Florida

Lead sponsor

Naveris, Inc.

Collaborator

Source ClinicalTrials.gov
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