Status:
NOT_YET_RECRUITING
PATH Trial: Personalized Approaches in the Treatment of Head and Neck Cancer
Lead Sponsor:
British Columbia Cancer Agency
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
Phase:
NA
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 wit...
Detailed Description
Head and neck cancer is the 12th most common cancer in Canada, with 6450 patients diagnosed per year.1 The majority of head and neck cancers are squamous cell carcinoma (H\&N SCC). The majority of H\&...
Eligibility Criteria
Inclusion
- 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
- • 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
Key Trial Info
Start Date :
August 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2032
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT05373251
Start Date
August 1 2022
End Date
August 1 2032
Last Update
May 13 2022
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