IMPERIAL

PROTOCOL TITLE

FDG PET, and circulating tumour HPV DNA during chemoRadiotherapy In p16-positive AnaL squamous cell carcinoma: The IMPERIAL study

PURPOSE OF STUDY

This is a prospective, non-randomised, observational phase II study, investigating whether F-18 fluorodeoxyglucose – Positron emission tomography (FDG-PET), circulating Human papilloma virus (HPV) tumour deoxyribonucleic acid (DNA) parameters at 2 weeks after commencement of standard radical chemoradiotherapy for anal squamous cell carcinoma can be used as biomarkers to predict locoregional tumour response at 6 months.

ELIGIBILITY CRITERIA

Main Inclusion Criteria:

• Age ≥18
• Patient willing and able to give written informed consent
• Patient deemed suitable for chemoradiotherapy (CRT) treatment protocol as determined by both a medical oncologist and a radiation oncologist
• Biopsy confirming histological diagnosis of primary invasive anal squamous cell carcinoma, and documentation of p16 immunohistochemistry status
• Primary tumour (T) Regional lymph nodes (N) Distant metastases (M) (TNM) stage T1-T4 N0-N1 M0 (AJCC 8th edition), determined by
  1. Clinical groin examination
  2. Digital rectal examination (DRE)
  3. Examination under anaesthesia (EUA) or anoscopy
  4. Computed tomography (CT) chest, abdomen and pelvis (with IV contrast unless contraindicated)
• Documentation of size of primary lesion

Main Exclusion Criteria:

• Women lactating, pregnant or of childbearing potential with inadequate contraception
• Patients who have previously received systemic therapy for anal cancer, or previous radiotherapy to the pelvis
• Previous HPV-related malignancy within the last 3 years
• Macroscopic surgical resection of the primary anal cancer
• P16 negative on immunohistochemical staining (note: equivocal staining pattern not an exclusion)
• Eastern Cooperative Oncology Group (ECOG) performance status >2
• Patients with significant medical or psychosocial conditions that may impact their ability to understand or complete the treatment protocol and study requirements
• Distant metastatic disease (M1)

CONTACT EMAIL

SWSLHD-RadOncClinicalTrials@health.nsw.gov.au

STUDY CHAIRS

Dr Natalie Collier

DETAILED INFORMATION AVAILABLE

Available online at the Australian New Zealand Clinical Trial Registry (ANZCTR) please click here.

FUNDING

The Royal Australian and New Zealand College of Radiologists
Department of Nuclear Medicine at Liverpool Hospital
Department of Radiation Oncology at Liverpool and Campbelltown Hospitals