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NCT04104945
p16+ Oropharyngeal Cancer Radiation Optimization Trial Reducing Elective Treatment Volumes (PROTEcT)
Conditions: Squamous Cell Carcinoma of the Oropharynx
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 15
Sponsor: AHS Cancer Control Alberta
Location: Tom Baker Cancer Centre/Arthur J E Child Comprehensive Cancer Centre Calgary Alberta
Summary
Volume and Dose De-Intensified Radiotherapy for p16+ Squamous Cell Carcinoma of the Oropharynx: A Multi-Centre, Single Arm Prospective Cohort Study
Eligibility Criteria
Inclusion Criteria:
* Age 18 or older
* Provide informed consent
* ECOG performance status 0-2
* Histologically confirmed squamous cell carcinoma
* p16-positive tumor, as determined by immunohistochemistry at local hospital
* Primary tumor site in the oropharynx (includes tonsil, soft palate, base of tongue, walls of oropharynx)
* Eligible for curative intent treatment.
* Smokers and non-smokers are included
* Tumor stage (AJCC 8th edition): T1 to T3
* Nodal stage (AJCC 8th edition): N1 to N2
* Adequate bone marrow function, hepatic, and renal function for chemotherapy (Hemoglobin \> 80 g/L; Absolute neutrophil count \>1.5x109 /L, platelets \> 100 x109/L; Bilirubin \< 35 umol/L; AST or ALT \< 3 x the upper limit of normal; serum creatinine \< 130 umol/L or creatinine clearance ≥ 50 ml/min)
Exclusion Criteria:
* \- Clinical, radiologic or pathologic Ib nodal involvement (including invasion into submandibular gland)
* Primary cancer with extension and involvement of the oral cavity
* Metastatic disease
* Contraindications to radiotherapy or chemotherapy
* Prior history of head and neck cancer within 5 years
* Prior head and neck radiation at any time
* Inability to attend full course of radiotherapy or follow-up visits
* Pregnant or lactating women
Source: ClinicalTrials.gov (NCT04104945). StuddyBuddy aggregates publicly available trial information.