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

Primary Purpose

Squamous Cell Carcinoma of the Oropharynx

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
De-intensified chemoradiotherapy
Sponsored by
AHS Cancer Control Alberta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Squamous Cell Carcinoma of the Oropharynx

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tom Baker Cancer CentreRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

De-intensified chemoradiotherapy

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 24, 2019
Last Updated
July 19, 2023
Sponsor
AHS Cancer Control Alberta
Collaborators
Tom Baker Cancer Centre, Cross Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04104945
Brief Title
p16+ Oropharyngeal Cancer Radiation Optimization Trial Reducing Elective Treatment Volumes (PROTEcT)
Acronym
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 12, 2021 (Actual)
Primary Completion Date
October 21, 2023 (Anticipated)
Study Completion Date
October 21, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AHS Cancer Control Alberta
Collaborators
Tom Baker Cancer Centre, Cross Cancer Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Squamous Cell Carcinoma of the Oropharynx

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
De-intensified chemoradiotherapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
De-intensified chemoradiotherapy
Intervention Description
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 Measure Information:
Title
Xerostomia-related quality of life
Description
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
Title
Toxicity Criteria for Adverse Events
Description
Measured by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time Frame
Baseline to 5 years
Other Pre-specified Outcome Measures:
Title
Overall survival
Description
Time from treatment initiation to death from any cause
Time Frame
Baseline to 5 years
Title
Progression-free survival
Description
Time from treatment initiation to disease progression or death from any cause
Time Frame
Baseline to 5 years
Title
Local, regional, and distant failure rates
Description
Time from treatment initiation to local, regional, and distant failure
Time Frame
Baseline to 5 years
Title
Swallowing function
Description
Measured by fibre-optic endoscopic evaluation of swallowing (FEES) or modified barium swallow (MBS)
Time Frame
12 months
Title
#1 Quality of life
Description
The primary study endpoint is the Xerostomia Questionnaire (XQ), 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.
Time Frame
Baseline to 5 years
Title
#2 Quality of life
Description
Measured by the MD Anderson Symptom Inventory - Head & Neck (MDASI-HN); a questionnaire used to assess the severity of head and neck cancer-related symptoms and their impact on six daily activities (general activity, mood, work, relations with others, walking, and enjoyment of life). Severity of symptoms are assessed on a 0-10 numerical scale, with 0 being "not present" and 10 being "as bad as you can imagine." The ratings can be averaged into several subscale scores: mean core symptom severity (13 core symptom items), mean module symptom severity (additional module symptom items if using a module), mean total symptom severity (13 core symptom items plus additional module symptom items if using a module), and mean interference (6 interference items only). The interference with daily activities is rated on a 0-10 numerical scale, 0 being "did not interfere" and 10 being "interfered completely." The mean of the interference items can be used to represent overall symptom distress.
Time Frame
Baseline to 5 years
Title
#3 Quality of life
Description
Measured by the MD Anderson Dysphagia Inventory (MDADI), which is a 20 item self-administered questionnaire designed for evaluating the impact of dysphagia on the QOL of patients with head and neck cancer. Five responses (strongly agree, agree, no opinion, disagree, and strongly disagree) are available to each question and are scored on a scale of 1 to 5. The MDADI quantifies an individual's global (G), physical (P), emotional (E), and functional (F) perceptions of their swallowing ability. Two summary scores can be obtained: 1) global and 2) composite. The global scale is a single question, which is scored individually to assess the overall impact that swallowing abilities have on QOL. The composite MDADI score summarizes overall performance on remaining 19 items of the MDADI, as a weighted average of the P, E, and F subscales. MDADI scores are normalized to range from 20 (extremely low functioning) to 100 (high functioning).
Time Frame
Baseline to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Harvey Quon, MD
Phone
403-521-3619
Email
harvey.quon@ahs.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Kelsey Meyer
Email
Kelsey.Meyer@ahs.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harvey Quon, MD
Organizational Affiliation
Tom Baker Cancer Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tom Baker Cancer Centre
City
Calgary
State/Province
Alberta
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Harvey Quon, MD
Email
Harvey.Quon@ahs.ca
First Name & Middle Initial & Last Name & Degree
Kelsey Meyer
Email
Kelsey.Meyer@ahs.ca

12. IPD Sharing Statement

Plan to Share IPD
No

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

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