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p16+ Oropharyngeal Cancer Radiation Optimization Trial Reducing Elective Treatment Volumes (PROTEcT)

ConditionSquamous Cell Carcinoma of the Oropharynx
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAHS Cancer Control Alberta

About this trial

Volume and Dose De-Intensified Radiotherapy for p16+ Squamous Cell Carcinoma of the Oropharynx: A Multi-Centre, Single Arm Prospective Cohort Study

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 or older

Provide informed consent

ECOG performance status 0-2

Histologically confirmed squamous cell carcinoma

Disqualifiers

- 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

Trial design

Design model

Single group

Treatments tested in this trial

  • De-intensified chemoradiotherapy

    Radiation

    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.

Treatment groups

32 Participants
are divided into 1 treatment group
Group A: De-intensified chemoradiotherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Xerostomia-related quality of life

Measured by the Xerostomia Questionnaire (XQ), which is an 8 item self-reported xerostomia specific questionnaire. Patients rate each item on an 11 point ordinal Likert scale from 0 to 10, with higher scores indicating greater dryness or discomfort due to dryness. Item scores are added and the sum is transformed linearly to a final summary score ranging between 0 and 100, with higher scores representing greater levels of xerostomia. Based on existing literature, the mean XQ score for patients treated with standard dose and volume radiotherapy is estimated to be 52 (null hypothesis). To detect a clinically meaningful reduction of 11 points in patients treated with volume and dose de-intensified radiotherapy, with a resulting mean XQ score of 41 (alternative hypothesis), with an alpha of 0.05 and 80% power using a one-sided Wilcoxon test assuming normal distribution, 28 patients are required. Accounting for 10% dropout a total sample size of 32 patients is required.

Time frame
12 months
2

Toxicity Criteria for Adverse Events

Measured by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0

Time frame
Baseline to 5 years

Secondary outcomes

Other outcomes

1

Overall survival

Time from treatment initiation to death from any cause

Time frame
Baseline to 5 years
2

Progression-free survival

Time from treatment initiation to disease progression or death from any cause

Time frame
Baseline to 5 years
3

Local, regional, and distant failure rates

Time from treatment initiation to local, regional, and distant failure

Time frame
Baseline to 5 years
4

Swallowing function

Measured by fibre-optic endoscopic evaluation of swallowing (FEES) or modified barium swallow (MBS)

Time frame
12 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

AHS Cancer Control Alberta

Lead sponsor

Tom Baker Cancer Centre

Collaborator

Cross Cancer Institute

Collaborator

Source ClinicalTrials.gov
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