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

NCT04104945 | Recruiting DMC

• 1 other identifier: PROTEcT
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Squamous Cell Carcinoma of the Oropharynx

Outcome Measures

Primary Outcomes (2)

• 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.

  12 months

• Toxicity Criteria for Adverse Events

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

  Baseline to 5 years

Other Outcomes (7)

• Overall survival

  Baseline to 5 years

• Progression-free survival

  Baseline to 5 years

• Local, regional, and distant failure rates

  Baseline to 5 years

Study Arms (1)

De-intensified chemoradiotherapy

EXPERIMENTAL

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.

Radiation: De-intensified chemoradiotherapy

Interventions

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.

De-intensified chemoradiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• \- 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

Sponsors & Collaborators

• AHS Cancer Control Alberta: lead
• Tom Baker Cancer Centre: collaborator
• Cross Cancer Institute: collaborator

Study Sites (1)

Tom Baker Cancer Centre

Calgary, Alberta, Canada

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Study Officials

• Harvey Quon, MD

  Tom Baker Cancer Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Harvey Quon, MD

CONTACT

403-521-3619; harvey.quon@ahs.ca

Kelsey Meyer

CONTACT

Kelsey.Meyer@ahs.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2019
• First Posted: September 26, 2019
• Study Start: January 12, 2021
• Primary Completion (Estimated): October 21, 2028
• Study Completion (Estimated): October 21, 2028
• Last Updated: March 4, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)