p16+ Oropharyngeal Cancer Radiation Optimization Trial Reducing Elective Treatment Volumes (PROTEcT)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: De-intensified chemoradiotherapy.
- Who it may be relevant to
- Registry conditions: Squamous Cell Carcinoma of the Oropharynx. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Volume and Dose De-Intensified Radiotherapy for p16+ Squamous Cell Carcinoma of the Oropharynx: A Multi-Centre, Single Arm Prospective Cohort Study
Overview
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 elective nodal volumes.
Chemotherapy will be administered as per standard of care, consisting of concurrent cisplatin (high-dose: 100mg/m2 IV every 3 weeks or low-dose: 40mg/m2 IV every week) or cetuximab (at the discretion of medical oncologist).
Interventions
- Radiation De-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.
Primary outcome measures
- Xerostomia-related quality of life [Time frame: 12 months]
- Toxicity Criteria for Adverse Events [Time frame: Baseline to 5 years]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Canada · 1 center
- Tom Baker Cancer Centre — Calgary
Identifiers
NCT: NCT04104945 · PROTEcT