NCT04104945Active, not recruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 28 Oct 2026
Brief summary (registry, in English)
Volume and Dose De-Intensified Radiotherapy for p16+ Squamous Cell Carcinoma of the Oropharynx: A Multi-Centre, Single Arm Prospective Cohort Study
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 15 (actual)
- First submitted
- 24 Sept 2019
- Start date
- 12 Jan 2021
- Primary completion date
- 21 Oct 2028
- Lead sponsor
- AHS Cancer Control Alberta
- Diseases
- Head and neck cancer
- NCT number
- NCT04104945
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 15
- From 12 Jan 2021 to the primary completion date, 21 Oct 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Primary cancer with extension and involvement of the oral cavity
- Metastatic disease
Other
- \- Clinical, radiologic or pathologic Ib nodal involvement (including invasion into submandibular gland)
- Pregnant or lactating women
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tom Baker Cancer Centre/Arthur J E Child Comprehensive Cancer Centre Coordinator of this site? Confirm its status | Calgary | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.