RecruitingNot ApplicableNCT04104945
p16+ Oropharyngeal Cancer Radiation Optimization Trial Reducing Elective Treatment Volumes (PROTEcT)
Volume and Dose De-Intensified Radiotherapy for p16+ Squamous Cell Carcinoma of the Oropharynx: A Multi-Centre, Single Arm Prospective Cohort Study
Sponsor
AHS Cancer Control Alberta
Enrollment
32 participants
Start Date
Jan 12, 2021
Study Type
INTERVENTIONAL
Conditions
Summary
Volume and Dose De-Intensified Radiotherapy for p16+ Squamous Cell Carcinoma of the Oropharynx: A Multi-Centre, Single Arm Prospective Cohort Study
Eligibility
Min Age: 18 Years
Inclusion Criteria11
- 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 Criteria8
- \- 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
Interventions
RADIATIONDe-intensified chemoradiotherapy
Radiotherapy to a dose of 60 Gy to the primary tumour and involved lymph nodes and 54 Gy to subclinical regions at risk in 30 fractions. Reduced volume of elective nodal radiation.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT04104945
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