Investigating the role of interim Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI) and blood markers to predict local and regional failure in patients with anal squamous cell carcinoma.
- Conditions
- Anal CancerCancer - Bowel - Anal
- Registration Number
- ACTRN12623001098628
- Lead Sponsor
- South Western Sydney Local Health District
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 28
Age greater than or equal to 18
- Patient willing and able to give written informed consent
- Patient deemed suitable for 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
- TNM stage T1-T4 N0-N1 M0 (AJCC 8th edition), determined by
-Clinical groin examination
-DRE
-EUA or anoscopy- CT chest, abdomen and pelvis (with IV contrast unless contraindicated)
-Documentation of size of primary lesion
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)
- 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)
If enrolled into the MRI sub-study:
- Inability to have an MRI due to severe claustrophobia, implanted incompatible devices (including pacemakers and implantable defibrillators) or magnetic material (e.g. bullet shrapnel, intraocular metal).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ocoregional failure will be assessed by using FDG PET, MRI imaging and HPV ctDNA biomarker testing.[ 6 months post chemoradiation treatment];MTV 2.5 will be assessed using FDG-PET imaging.[ 2 weeks during chemoradiation treatment, 3 and 6 months post chemoradiation treatment];Diffusion weighted images with B values 50, 400 and 800 will be assessed using MRI[ 2 weeks during Chemoradiation treatment]
- Secondary Outcome Measures
Name Time Method Quantification of HPV ctDNA assessed by blood sample analysis[ 2 weeks during chemoradiation treatment, 3 and 6 months post chemoradiation treatment];Volumetric changes indicating progression free survival i.e <30% increase in volume as per RECISTS1.1 using FDG-PET and MRI imaging[ 2 weeks during chemoradiation and 3 and 6 months post chemoradiation]