Testing Less Intensive Radiation With Chemotherapy to Treat Low-risk Patients With HPV-positive Oropharyngeal Cancer
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
About this study
This trial will explore giving standard dose chemotherapy and radiation therapy to sites of disease including all lymph nodes involved with HPV-positive oropharyngeal cancer, but administer lower doses of radiation therapy to the lymph nodes that are not known to be involved with cancer. By doing so, it is hypothesized that there will be equally good long term loco-regional and distant disease control but will reduced long term treatment side effects and improved quality of life in persons living well beyond their cancer treatment.
Sponsor: University of Missouri-Columbia
You may qualify if…
- ✓ Patients generally must have the psychological ability and general health that permits completion of the study requirements and required follow up.
- ✓ Women of childbearing potential and men who are sexually active should be willing and able to use medically acceptable forms of contraception throughout the treatment phase of the trial and until at least 60 days following the last study treatment.
- ✓ Pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma (including the histological variants papillary squamous cell carcinoma and basaloid squamous cell carcinoma) of the oropharynx (tonsil, base of tongue, soft palate, or oropharyngeal walls); cytologic diagnosis from a cervical lymph node is sufficient in the presence of clinical evidence of a primary tumor in the oropharynx. Clinical evidence should be documented, may consist of palpation, imaging, or endoscopic evaluation, and should be sufficient to estimate the size of the primary (for T stage).
- ✓ Patients must have clinically or radiographically evident measurable disease at the primary site or at nodal stations. Tonsillectomy or local excision of the primary without removal of nodal disease is permitted, as is excision removing gross nodal disease but with intact primary site. Limited neck dissections retrieving ≤ 4 nodes are permitted and considered as non-therapeutic nodal excisions.
- ✓ Immunohistochemical staining for p16 must be performed on tissue and documented in the pathology report(s) with reported result positive for p16.
- ✓ Clinical stage T1-T3, N0-N2c (AJCC, 7th ed.), which is equal to T1-T3, N0-2 (AJCC, 8th ed.) including no distant metastases based on the following diagnostic workup:
- ✓ General history and physical examination within 30 days prior to registration;
- ✓ Fiberoptic exam with laryngopharyngoscopy (mirror and/or fiberoptic and/or direct procedure) within 60 days prior to registration;
You may not qualify if…
- ✕ Cancers considered to be from an oral cavity site (oral tongue, floor mouth, alveolar ridge, buccal or lip), or the nasopharynx, hypopharynx, or larynx, even if p16 positive;
- ✕ Carcinoma of the neck of unknown primary site origin (even if p16 positive);
- ✕ T1-T2 N0-1 lateralized squamous cell carcinoma of the tonsil.
- ✕ Radiographically matted nodes, that span 6 cm or more; N3 disease
- ✕ Supraclavicular nodes, defined as nodes visualized on the same axial imaging slice as the clavicle;
- ✕ Definitive clinical or radiologic evidence of metastatic disease or adenopathy below the clavicles;
- ✕ Gross total excision of both primary and nodal disease; this includes tonsillectomy, local excision of primary site, and nodal excision that removes all clinically and radiographically evident disease.
- ✕ Simultaneous primary cancers or separate bilateral primary tumor sites;
Where it's recruiting
Columbia
Source: ClinicalTrials.gov · NCT04444869 · last updated 2024-05-17