Clinical Trials /

A Study of SBRT for Squamous Cell Carcinoma of the Head and Neck

NCT04435938

Description:

To evaluate the tumour response rate of squamous cell carcinoma of the head and neck following stereotactic body radiotherapy (SBRT) of 45Gy in 5 fractions delivered once every 3-4 days, such that treatment is completed within 15 days.

Related Conditions:
  • Head and Neck Squamous Cell Carcinoma
  • Skin Squamous Cell Carcinoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Study of SBRT for Squamous Cell Carcinoma of the Head and Neck
  • Official Title: A Phase 2 Study of SBRT for Squamous Cell Carcinoma of the Head and Neck

Clinical Trial IDs

  • ORG STUDY ID: 8134
  • NCT ID: NCT04435938

Conditions

  • Head and Neck Neoplasms
  • Squamous Cell Carcinoma
  • Squamous Skin Carcinoma

Purpose

To evaluate the tumour response rate of squamous cell carcinoma of the head and neck following stereotactic body radiotherapy (SBRT) of 45Gy in 5 fractions delivered once every 3-4 days, such that treatment is completed within 15 days.

Detailed Description

      Cancers of the head and neck region account for approximately 4% of all new cancer cases.
      Primary skin cancers are the most common malignancy diagnosed in North America with the
      majority of tumours arising in the cervico-facial region.Together, these tumours comprise a
      high burden of illness and are often characterized by locally advanced, non-metastatic
      disease.

      Determining the optimal treatment for individual patients with advanced cervico-facial
      cancers of the skin or primary head and neck squamous cell carcinoma (HNSCC) is clinically
      challenging; standard treatments include combinations of surgery, radiation and chemotherapy,
      all of which are associated with high rates of acute toxicity and complications. A
      meta-analysis of randomized controlled trials did not demonstrate benefit with concurrent
      chemotherapy in patients over the age of 70 or with performance status ≥ 2, and it is
      recognized that the high burden of medical co-morbidities in HNSCC is associated with poorer
      prognosis. Some patients without distant metastases may be deemed to have 'incurable' disease
      due to very advanced tumours, recurrence, severe medical co-morbidities or frailty that
      prohibit the use of standard surgery, general anaesthetic and/or radiotherapy over 6-7 weeks.

      When conventional surgery and/or radiotherapy are not recommended by the multi-disciplinary
      team then patients may be treated with shorter, hypo-fractionated radiotherapy with the goal
      of symptom relief and local control but at the cost of a lower biological dose. Investigators
      at the Juravinski Cancer Centre published retrospective results from the '0-7-21' regimen
      using 24 Gy / 3 fractions which was well tolerated and provided temporary symptom relief in
      82% of patients but reported 6 month progression free survival of 39% within the irradiated
      field; a phase 2 study of previously untreated HNSCC patients deemed to have incurable
      disease used up to 42 Gy/12 fractions and demonstrated similar rates of initial response and
      symptom relief but a short progression free survival duration of 3.1 months. One study
      reported an institutional experience of palliative radiotherapy in newly diagnosed head and
      neck cancer patients who were deemed to have incurable disease and received a wide range of
      dose/fractionation regimens. The median radiation dose was 50 Gy and between 57-82% of
      patients were reported to have any radiological, clinical or symptomatic response to
      treatment. In these three studies, the patients were older with median ages of 71, 73, and 77
      years - and median survival was short 5.2, 5.7 and 6.2 months.

      With respect to squamous cell carcinoma (SCC) of the skin, there is limited evidence to guide
      treatment in patients with unresectable or medically inoperable disease, particularly in the
      head and neck region. There is a need for prospective data on non-surgical treatment options
      for frail older adults which improve efficacy while limiting the treatment burden.

      SBRT can limit the number of treatments while delivering a higher, potentially curative dose.
      An international consortium of 15 high volume cancer centres reported on a survey of
      practices using SBRT for head and neck cancers. There was heterogeneity in the indications,
      techniques and doses reported by various institutions. The most common indication was in the
      setting of recurrent disease and reported doses were in the range of 35-50 Gy in 3-5
      fractions. Several institutions reported 1-2 year local control rates of 65-90% with SBRT and
      acceptable levels of toxicity. To our knowledge, there are no prospective clinical studies
      evaluating tumour response, toxicity and quality of life in previously unirradiated patients.

      The goal of the current study is to prospectively evaluate tumour response, toxicity and
      patient quality of life in patients with HNSCC undergoing SBRT.
    

Trial Arms

NameTypeDescriptionInterventions
Stereotactic Body Radiotherapy (SBRT)ExperimentalThe dose prescribed in the study will be 45Gy in 5 fractions, delivered once every 3-4 days, such that treatment is completed within 15 days. (e.g. treatment given on Monday/Thursday/Mon/Thurs/Mon) (Exceptions: treatment duration of up to 18 days will be allowed to account for cancer centre closures and unforeseen patient issues.)

    Eligibility Criteria

            Inclusion Criteria:
    
              1. Age >= 60 years
    
              2. Histologically confirmed diagnosis of squamous cell carcinoma of the head and neck
                 region including primary skin SCC; (malignant cells with suspicious/likely SCC will be
                 considered for study if repeat biopsy is not feasible)
    
              3. Clinical stage ≥ T2, or any T-stage with N1-N3 disease, M0 or Mx
    
              4. Measurable tumour present in the head and neck region on clinical examination and/or
                 imaging at time of study enrollment
    
              5. All patients will be assessed by a multi-disciplinary, head and neck oncology team
                 with no systemic therapy being recommended at the time of enrollment
    
              6. Primary surgery not recommended/performed due to any of the following:
    
                   -  Unresectable disease and/or borderline resectable
    
                   -  Medically inoperable / deemed high risk for post-operative morbidity/mortality by
                      surgical team
    
                   -  Patient declined surgery
    
              7. Deemed not to be a candidate for standard fractionation radiotherapy due to poor
                 performance status and/or medical co-morbidities and/or advanced stage disease
    
              8. Eastern Co-operative Oncology Group (ECOG) Performance Status ≤ 3
    
            Exclusion Criteria:
    
              1. Life expectancy ≤ 3 months
    
              2. Chemotherapy or other systemic cancer therapy within 3 months prior to HN SBRT
    
              3. Basal cell carcinoma, Merkel cell, malignant melanoma, adenocarcinoma are excluded
    
              4. HN surgery within 6 months prior to HN SBRT (excision under local anaesthesia is
                 acceptable)
    
              5. Prior radiation treatment to the head and neck region (prior radiotherapy to the skin
                 for non-melanoma skin cancer and deemed to have no risk of overlap with the current
                 field are eligible)
    
              6. Synchronous or recent cancer diagnosis not including the index cancer (other cancers
                 treated curatively with no evidence of disease for >=3 years, or other non- melanoma
                 skin cancers treated with no evidence of disease for >= 6 months are eligible)
    
              7. Confirmed or known distant metastatic disease.
    
              8. Serious non-malignant disease that precludes definitive radiation treatment (e.g.
    
                 severe cases of scleroderma, systemic lupus erythematosus, rheumatoid arthritis)
    
              9. Unable to provide written, informed consent or complete QoL questionnaires and
                 assessments required on the study
    
             10. Unable to lie flat for 60 minutes in order to have radiation planning and treatment
    
             11. Unable to attend radiation planning and therapy, as well as follow-up care and
                 assessments
    
             12. Unable to provide written, informed consent
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:60 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Tumour response rate
    Time Frame:The best overall response across all time points during the study period - up to 24 months after completion of SBRT.
    Safety Issue:
    Description:Tumour response rate defined as complete or partial response according to Tumour response rate will be defined by RECIST 1.1 criteria

    Secondary Outcome Measures

    Measure:Number of participants with Acute and Late Toxicity
    Time Frame:Up to 24 months after completion of SBRT
    Safety Issue:
    Description:Acute toxicity (during and up to 3 months from the end of treatment) and late toxicity (after 3 months) adverse effects secondary to SBRT treatment will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE v5.0) scale.
    Measure:Local Control
    Time Frame:Determination of local recurrence will be based on based on RECIST criteria 1.1 (see section 11.3 below) and assessed on MRI or CT scan imaging at 12 weeks and any additional imaging/clinical assessments performed during the study.
    Safety Issue:
    Description:The absence of local progression of disease of the target lesions during the study period.
    Measure:Quality of Life as measured by the FACT-HN questionnaire
    Time Frame:The FACT-HN Quesionnaire will be administered at Baseline, once during treatment, 6 weeks, 3, 6, 12 months post SBRT treatment. Higher scores represent better qualtiy of life.
    Safety Issue:
    Description:Assessed using the FACT-HN questionnaire

    Details

    Phase:Phase 2
    Primary Purpose:Interventional
    Overall Status:Not yet recruiting
    Lead Sponsor:McMaster University

    Trial Keywords

    • Head and Neck Cancer
    • Squamous Cell Cancer
    • Squamous Skin Cancer
    • Stereotactic Body Radiotherapy
    • SBRT
    • Radiation Therapy

    Last Updated

    June 15, 2020