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PATH Trial: Personalized Approaches in the Treatment of Head and Neck Cancer (PATH)

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. Identifier: NCT05373251
Recruitment Status : Not yet recruiting
First Posted : May 13, 2022
Last Update Posted : May 13, 2022
Information provided by (Responsible Party):
British Columbia Cancer Agency

Brief Summary:
  1. To determine genomic markers of radioresistance by comparing patients with H&N cancer who develop recurrence within twelve months of curative intent radiation and/or chemoradiotherapy to those without recurrence
  2. To compare the genomic landscape of patients with and without EBV and HPV mediated H&N cancer
  3. To identify somatic mutations, gene expression changes or other potentially targetable abnormalities in patients with recurrent H&N cancer that may provide information to guide systemic therapy in these patients

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Diagnostic Test: Whole genomic DNA/RNA tumour sequencing Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: PATH Trial: Personalized Approaches in the Treatment of Head and Neck Cancer
Estimated Study Start Date : August 2022
Estimated Primary Completion Date : August 2027
Estimated Study Completion Date : August 2032

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Whole genomic DNA/RNA tumour sequencing
All participants will undergo pre-radiotherapy fresh core biopsies of the tumour. DNA libraries will be created and stored for future analysis.
Diagnostic Test: Whole genomic DNA/RNA tumour sequencing

All participants will undergo pre-radiotherapy fresh core biopsies of the tumour. DNA libraries will be created and stored for future analysis.

Participants with recurrence will have biopsy and subsequently will undergo rapid sequencing of RNA and DNA followed by bioinformatic analysis to identify somatic mutations or other abnormalities that might be "drivers" of an individual's cancer or predict response to therapies. These data will be compared to the literature and to a comprehensive database of drugs with the aim of identifying drugs most likely to target individual tumors based on the presence of mutated or abnormally expressed genes in the tumor. Any palliative systemic therapy treatment would be closely monitored for tolerability and response, as part of the general clinical care of someone on systemic therapy. The choice of systemic therapy will be up to the treating medical oncologist and the patient.

Primary Outcome Measures :
  1. Number of participants with local, regional and distant recurrence [ Time Frame: 24 months post completion of radiotherapy ]
    Proportion with recurrence

Secondary Outcome Measures :
  1. Proportion who have sufficient biopsy possible to perform WGTA [ Time Frame: 5 years ]
    To assess feasability of WGTA in this population

  2. Proportion of patients with recurrence where actionable alterations are identified. [ Time Frame: 5 years ]
    To determine the frequency of actionable mutations

  3. Treatment response [ Time Frame: 24 months, 5 years ]
    Determine the utility of WGTA informed therapy

  4. Overall survival, disease specific survival, progression-free survival [ Time Frame: 12 months, 24 months, 5 years ]
    survival outcomes

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with locally advanced H&N squamous cell carcinoma or nasopharyngeal cancer undergoing definitive radiation and/or chemoradiotherapy with curative intent at BC Cancer
  • Folowing subsites included: paranasal sinus, nasal cavity, nasopharynx, oral cavity, oropharynx, larynx, hypopharynx.
  • Patients willing to undergo study specific fresh biopsy of the tumour, and/or metastatic nodal site at baseline and at recurrence, and a blood test for genomic analysis.
  • ECOG PS 0-2
  • Age >/=18 years
  • Primary tumour or regional lymph nodes that are amenable to core biopsy and sufficient sampling for POG purposes
  • Measurable disease
  • Adequate organ function
  • Willingness to have their de-identified genomic and clinical data shared with national and international research collaborators and data sharing platforms (as detailed in the consent form)
  • Willingness to be contacted for future studies based on the data that is generate; included in this is the anticipation that patient would be fit or a candidate for clinical trials

Exclusion Criteria:

  • • Primary skin, salivary gland and thyroid malignancies

    • Unwilling/unable to undergo biopsies and blood tests
    • Patients undergoing adjuvant radiotherapy after definitive surgery without gross residual disease
    • Patients with estimated life expectancy less than 12 months
    • Patients who have received prior chemoradiotherapy within the past 12 months
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Responsible Party: British Columbia Cancer Agency Identifier: NCT05373251    
Other Study ID Numbers: H21-03699
First Posted: May 13, 2022    Key Record Dates
Last Update Posted: May 13, 2022
Last Verified: May 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
Keywords provided by British Columbia Cancer Agency:
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site