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

NCT05373251 | Not Yet Recruiting DMC

• 1 other identifier: H21-03699
• Study Type: interventional
• Target: 500
• Locations: 0 countries
• Sites: N/A

Brief Summary

1. 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. 2.To compare the genomic landscape of patients with and without EBV and HPV mediated H\&N cancer
3. 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

Conditions

Head and Neck Cancer

Keywords

Oncogenomics

Outcome Measures

Primary Outcomes (1)

• Number of participants with local, regional and distant recurrence

  Proportion with recurrence

  24 months post completion of radiotherapy

Secondary Outcomes (4)

• Proportion who have sufficient biopsy possible to perform WGTA

  5 years

• Proportion of patients with recurrence where actionable alterations are identified.

  5 years

• Treatment response

  24 months, 5 years

• Overall survival, disease specific survival, progression-free survival

  12 months, 24 months, 5 years

Study Arms (1)

Whole genomic DNA/RNA tumour sequencing

EXPERIMENTAL

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

Interventions

Whole genomic DNA/RNA tumour sequencing DIAGNOSTIC_TEST

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.

Whole genomic DNA/RNA tumour sequencing

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• British Columbia Cancer Agency: lead

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2022
• First Posted: May 13, 2022
• Study Start: August 1, 2022
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2032
• Last Updated: May 13, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share