Status:
RECRUITING
p16+ Oropharyngeal Cancer Radiation Optimization Trial Reducing Elective Treatment Volumes (PROTEcT)
Lead Sponsor:
AHS Cancer Control Alberta
Collaborating Sponsors:
Tom Baker Cancer Centre
Cross Cancer Institute
Conditions:
Squamous Cell Carcinoma of the Oropharynx
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Volume and Dose De-Intensified Radiotherapy for p16+ Squamous Cell Carcinoma of the Oropharynx: A Multi-Centre, Single Arm Prospective Cohort Study
Detailed Description
De-intensified 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. Omission of level IB lymph node regions from the...
Eligibility Criteria
Inclusion
- 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
- \- 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
Key Trial Info
Start Date :
January 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 21 2028
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT04104945
Start Date
January 12 2021
End Date
October 21 2028
Last Update
March 4 2024
Active Locations (1)
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1
Tom Baker Cancer Centre
Calgary, Alberta, Canada