Clinical trial NCT04104945: p16+ Oropharyngeal Cancer Radiation Optimization Trial Reducing Elective Treatment Volumes (PROTEcT)
Official title: Volume and Dose De-Intensified Radiotherapy for p16+ Squamous Cell Carcinoma of the Oropharynx: A Multi-Centre, Single Arm Prospective Cohort Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Squamous Cell Carcinoma of the Oropharynx
Lead sponsor: AHS Cancer Control Alberta
Sponsor class: OTHER
Collaborators: name: Tom Baker Cancer Centre
name: Cross Cancer Institute
First posted: 2019-09-26
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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).

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

Primary outcomes:
measure: Xerostomia-related quality of life
timeFrame: 12 months
measure: Toxicity Criteria for Adverse Events
timeFrame: Baseline to 5 years
Secondary outcomes:
Other outcomes:
measure: Overall survival
timeFrame: Baseline to 5 years
measure: Progression-free survival
timeFrame: Baseline to 5 years
measure: Local, regional, and distant failure rates
timeFrame: Baseline to 5 years
measure: Swallowing function
timeFrame: 12 months
measure: #1 Quality of life
timeFrame: Baseline to 5 years
measure: #2 Quality of life
timeFrame: Baseline to 5 years
measure: #3 Quality of life
timeFrame: Baseline to 5 years
Locations:
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre
state: Alberta
Study officials:
affiliation: Tom Baker Cancer Centre
name: Harvey Quon, MD
role: PRINCIPAL_INVESTIGATOR
References: