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:

Not yet recruiting

Phase:

N/A

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

    Details

    Phase:N/A
    Primary Purpose:Interventional
    Overall Status:Not yet recruiting
    Lead Sponsor:AHS Cancer Control Alberta

    Last Updated