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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04104945
Recruitment Status : Recruiting
First Posted : September 26, 2019
Last Update Posted : July 19, 2022
Sponsor:
Collaborators:
Tom Baker Cancer Centre
Cross Cancer Institute
Information provided by (Responsible Party):
AHS Cancer Control Alberta

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

Condition or disease Intervention/treatment Phase
Squamous Cell Carcinoma of the Oropharynx Radiation: De-intensified chemoradiotherapy Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Volume and Dose De-Intensified Radiotherapy for p16+ Squamous Cell Carcinoma of the Oropharynx: A Multi-Centre, Single Arm Prospective Cohort Study
Actual Study Start Date : January 12, 2021
Estimated Primary Completion Date : October 21, 2023
Estimated Study Completion Date : October 21, 2023

Arm Intervention/treatment
Experimental: De-intensified chemoradiotherapy
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
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 Measures :
  1. Xerostomia-related quality of life [ Time Frame: 12 months ]
    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.

  2. Toxicity Criteria for Adverse Events [ Time Frame: Baseline to 5 years ]
    Measured by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0


Other Outcome Measures:
  1. Overall survival [ Time Frame: Baseline to 5 years ]
    Time from treatment initiation to death from any cause

  2. Progression-free survival [ Time Frame: Baseline to 5 years ]
    Time from treatment initiation to disease progression or death from any cause

  3. Local, regional, and distant failure rates [ Time Frame: Baseline to 5 years ]
    Time from treatment initiation to local, regional, and distant failure

  4. Swallowing function [ Time Frame: 12 months ]
    Measured by fibre-optic endoscopic evaluation of swallowing (FEES) or modified barium swallow (MBS)

  5. #1 Quality of life [ Time Frame: Baseline to 5 years ]
    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.

  6. #2 Quality of life [ Time Frame: Baseline to 5 years ]
    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.

  7. #3 Quality of life [ Time Frame: Baseline to 5 years ]
    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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04104945


Contacts
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Contact: Harvey Quon, MD 403-521-3619 harvey.quon@ahs.ca
Contact: Mahsa Alaee Mahsa.Alaee@ahs.ca

Locations
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Canada, Alberta
Tom Baker Cancer Centre Recruiting
Calgary, Alberta, Canada
Contact: Harvey Quon, MD       Harvey.Quon@ahs.ca   
Contact: Mahsa Alaee       Mahsa.Alaee@ahs.ca   
Sponsors and Collaborators
AHS Cancer Control Alberta
Tom Baker Cancer Centre
Cross Cancer Institute
Investigators
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Principal Investigator: Harvey Quon, MD Tom Baker Cancer Centre
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Responsible Party: AHS Cancer Control Alberta
ClinicalTrials.gov Identifier: NCT04104945    
Other Study ID Numbers: PROTEcT
First Posted: September 26, 2019    Key Record Dates
Last Update Posted: July 19, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Oropharyngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases