Risk Adapted De-Intensification of Radio-Chemotherapy for Oropharyngeal Squamous Cell Carcinoma (NCT05268614) | Clinical Trial Compass
RecruitingPhase 2
Risk Adapted De-Intensification of Radio-Chemotherapy for Oropharyngeal Squamous Cell Carcinoma
United States250 participantsStarted 2022-05-16
Plain-language summary
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).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. ≥ 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.
✓. ECOG Performance Status 0-2
✓. ≤10 pack-years of smoking or no smoking for ≥ 10 years
✓. Eligible for chemotherapy
✓. CBC/differential obtained within 12 weeks prior to treatment, with adequate bone marrow function defined as follows:
Exclusion criteria
✕. 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.
✕. Inhalation smoking of tobacco within the last 10 years with \> 10 pack-year equivalent history.
✕. Currently taking Disease Modifying Rheumatoid Drugs (DMRDs) or immunosuppressive medication, for example as for organ transplant or multiple sclerosis.
✕. Severe, active co-morbidity, defined as follows:
✕. Known HIV positivity. HIV positive patients are known to have worse clinical outcomes especially for local, regional, and distant cancer control. This poorer prognosis is thought to be secondary to a compromised immune system. Thus, de-intensification of radiation and chemotherapy is not justifiable in this population. HIV testing at the time of enrollment is not required.