Clinical Trials /

De-Escalation Radiotherapy in Patients With Low-Risk HPV-Related Oropharyngeal Squamous Cell Carcinoma

NCT03822897

Description:

The purpose of this study is to find out whether radiotherapy to some of the lymph node areas can be safely omitted to decrease side effects without increasing the risk of the tumour coming back.

Related Conditions:
  • Oropharyngeal Squamous Cell Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: De-Escalation Radiotherapy in Patients With Low-Risk HPV-Related Oropharyngeal Squamous Cell Carcinoma
  • Official Title: A Phase II Single Arm Trial of Elective Volume Adjusted De-Escalation Radiotherapy (EVADER) in Patients With Low-Risk HPV-Related Oropharyngeal Squamous Cell Carcinoma

Clinical Trial IDs

  • ORG STUDY ID: HN10
  • NCT ID: NCT03822897

Conditions

  • Oropharyngeal Cancer

Interventions

DrugSynonymsArms
CisplatinNo availableTwo Treatment Options

Purpose

The purpose of this study is to find out whether radiotherapy to some of the lymph node areas can be safely omitted to decrease side effects without increasing the risk of the tumour coming back.

Detailed Description

      The standard or usual treatment for this disease includes radiotherapy or radiotherapy
      combined with chemotherapy or antibody therapy.

      These treatments are highly effective at curing most patients with HPV-related cancer of the
      oropharynx, but short and long-term side effects from treatment can be significant.
    

Trial Arms

NameTypeDescriptionInterventions
Two Treatment OptionsOtherOption #1 - Radiotherapy 35 fractions, 5/wk, 7 wks 70Gy/56Gy Cisplatin 100mg/m2 on day 1, 22 and 43 or 40mg mg/m2/wk for 7 wks Option #2 - Radiation only-35 fraction, 6/wk, 6wks 70Gy/56Gy
  • Cisplatin

Eligibility Criteria

        Inclusion Criteria:

          -  Patients with pathologically proven diagnosis of HPV-related OPSCC

          -  Clinical stage T1-3 N0-1 M0 (UICC/AJCC 8th Ed.)

          -  Patients must be eligible for definitive RT or CRT

          -  Must be ≥ 18 years of age

          -  Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or
             2

          -  Patient is able (i.e. sufficiently fluent) and willing to complete the quality of life
             and health economics questionnaires in either English or French

          -  Patient consent must be appropriately obtained in accordance with applicable local and
             regulatory requirements. Each patient must sign a consent form prior to enrolment in
             the trial to document their willingness to participate

          -  Patients must be accessible for treatment and follow up. Patients registered on this
             trial must be treated and followed at the participating centre

          -  In accordance with CCTG policy, protocol treatment is to begin within 3 weeks of
             patient registration

          -  Women/men of childbearing potential must have agreed to use a highly effective
             contraceptive method

          -  The following radiological investigations must be done within 8 weeks of
             randomization: CT or MR of head and neck (MRI is recommended for base-of-tongue
             primary tumors); PET-CT scan.

          -  Patient must consent to provision of and investigator must confirm adequacy of
             non-cytology tissue samples and confirm access to and agree to submit within 4 weeks
             of randomization to the CCTG Central Tumour Bank, a representative formalin fix
             paraffin block of non-cytology tumour tissue in order that the specific correlative
             marker assays described may be conducted.

          -  Patient must consent to provision of samples of blood and plasma (for circulating cell
             free DNA) in order that the specific correlative marker assays described may be
             conducted.

          -  Patients with prior or concurrent malignancy whose natural history or treatment does
             not have the potential to interfere with the safety or efficacy assessment of the
             investigational regimen are eligible for this trial.

        Exclusion Criteria:

          -  Previous chemotherapy or radiotherapy treatment for head and neck cancer
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Event-free Survival
Time Frame:5 years
Safety Issue:
Description:Time to first progress event or censoring in year

Secondary Outcome Measures

Measure:Overall Survival
Time Frame:5 years
Safety Issue:
Description:Time to death or censoring in year
Measure:Local control
Time Frame:5 years
Safety Issue:
Description:Percentage of patients with local control
Measure:Regional Control
Time Frame:5 years
Safety Issue:
Description:Percentage of patients with regional control
Measure:Locoregional control
Time Frame:5 years
Safety Issue:
Description:Percentage of patients with local and regional control
Measure:Distant Metastasis-Free Survival
Time Frame:5 years
Safety Issue:
Description:Time to distant metastasis or censoring in year

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Canadian Cancer Trials Group

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