Actively Recruiting
p16+ Oropharyngeal Cancer Radiation Optimization Trial Reducing Elective Treatment Volumes (PROTEcT)
Led by AHS Cancer Control Alberta · Updated on 2024-03-04
32
Participants Needed
1
Research Sites
405 weeks
Total Duration
On this page
Sponsors
A
AHS Cancer Control Alberta
Lead Sponsor
T
Tom Baker Cancer Centre
Collaborating Sponsor
AI-Summary
What this Trial Is About
Volume and Dose De-Intensified Radiotherapy for p16+ Squamous Cell Carcinoma of the Oropharynx: A Multi-Centre, Single Arm Prospective Cohort Study
CONDITIONS
Official Title
p16+ Oropharyngeal Cancer Radiation Optimization Trial Reducing Elective Treatment Volumes (PROTEcT)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 or older
- Provide informed consent
- ECOG performance status 0-2
- Histologically confirmed squamous cell carcinoma
- p16-positive tumor confirmed by immunohistochemistry
- Primary tumor located in oropharynx (tonsil, soft palate, base of tongue, walls of oropharynx)
- Eligible for curative intent treatment
- Tumor stage T1 to T3 (AJCC 8th edition)
- Nodal stage N1 to N2 (AJCC 8th edition)
- Adequate bone marrow, liver, and kidney function for chemotherapy (Hemoglobin > 80 g/L; Absolute neutrophil count >1.5x10^9/L; Platelets > 100x10^9/L; Bilirubin < 35 umol/L; AST or ALT < 3x upper limit of normal; Serum creatinine < 130 umol/L or creatinine clearance ≥ 50 ml/min)
You will not qualify if you...
- Clinical, radiologic, or pathologic involvement of level IB lymph nodes (including submandibular gland invasion)
- Primary cancer extending into the oral cavity
- Metastatic disease
- Contraindications to radiotherapy or chemotherapy
- Prior head and neck cancer within 5 years
- Previous head and neck radiation treatment at any time
- Inability to attend full course of radiotherapy or follow-up visits
- Pregnant or lactating women
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Tom Baker Cancer Centre
Calgary, Alberta, Canada
Actively Recruiting
Research Team
H
Harvey Quon, MD
CONTACT
K
Kelsey Meyer
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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