Clinical Trials /

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

NCT04104945

Description:

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

Related Conditions:
  • Oropharyngeal Squamous Cell Carcinoma
Recruiting Status:

Recruiting

Phase:

N/A

URL:

https://clinicaltrials.gov/show/NCT04104945

Trial Eligibility

Document

Title

  • Brief Title: 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

Clinical Trial IDs

  • ORG STUDY ID: PROTEcT
  • NCT ID: NCT04104945

Conditions

  • Squamous Cell Carcinoma of the Oropharynx

Purpose

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).

Trial Arms

NameTypeDescriptionInterventions
De-intensified chemoradiotherapyExperimentalRadiotherapy 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.

    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
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Xerostomia-related quality of life
    Time Frame:12 months
    Safety Issue:
    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.

    Details

    Phase:N/A
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:AHS Cancer Control Alberta

    Last Updated

    June 22, 2021