NOAC9 - A Phase II Randomised Nordic Anal Cancer Group Study on Circulating Tumor DNA Guided Follow-Up
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 400
- Locations
- 13
- Primary Endpoint
- Disease free survival
Study Overview
Brief Summary
This study investigates if circulating tumor DNA can improve the detection of early treatment failure or recurrence in localized squamous cell carcinoma of the anus (SCCA) after curative chemoradiotherapy thereby increasing the potential for cure. This will be done by comparing the standard follow-up program with ctDNA guided imaging follow-up. Secondly, the aim is to establish early interventions against late morbidities.
Detailed Description
Squamous cell carcinoma of the anus (SCCA) is a rare disease with less than 200 new cases in Denmark and Sweden each year and approximately 100 new cases in Norway and Finland but with increasing incidence. Primary treatment is chemo-radiotherapy (CRT) comprising high dose IMRT based radiation therapy with combination chemotherapy of 5-FU and Cisplatin. Overall treatment response is good in small tumors, but less pronounced for high-risk tumors.
In absence of complete pathological response after CRT or local recurrence, patients are evaluated for. salvage surgery. The importance of R0 resection on overall survival has been described in several studies. It is suggested that early detection of treatment failure and recurrences increases the chance of possible curative surgery (R0-resection) and thereby overall survival.
A follow-up program has 3 purposes
- To detect lack of complete response to primary treatment
- Early detection of local or distant recurrences
- Describing and managing late morbidity
Purpose:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with SCCA eligible for definitive (chemo)radiotherapy
- •≥ 18 of years
- •Written and oral consent
Exclusion Criteria
- •Conditions that will contraindicate blood samples
- •Conditions that will contraindicate a PET-CT scan.
- •Potential lack of compliance to standard FU program and study participation.
Arms & Interventions
ARM B: HPV positive ctDNA guided imaging in follow-up
The national follow-up program + ctDNA guided additional imaging + collection of blood samples for retrospective translational research
Intervention: AMR B: HPV positive ctDNA guided imaging in follow-up (Diagnostic Test)
ARM O: HPV negative observational arm
Patients with HPV negative disease will be included in an observational arm (ARM O)
ARM O: The national follow-up program + collection of blood samples for retrospective translational research
ARM A: HPV positive standard of care follow-up
The national follow-up program + collection of blood samples for retrospective translational research
Outcomes
Primary Outcomes
Disease free survival
Time Frame: after 2 years
Disease free survival 2 years from end of therapy
Secondary Outcomes
- ctDNA assays for HPV negative cases(5 years)
- Health related quality of life(after 2 and 5 years)
- Overall survival(5 years)
- The rate of distant failures(after 5 years)
- Time between ctDNA detected and CT verified recurrences(after 5 years)
- Rate of succesful salvage surgery(after 5 years)
- Pattern of failure(after 5 years)
- Disease free survival at 5 years follow-up(after 5 years)
- Explorative analysis of total circulating free DNA (cfDNA)(5 years)
- Acute toxicity(after 2 and 5 years)
- Late toxicity(after 2 and 5 years)
Investigators
Karen-Lise Garm Spindler
Professor, Dr. Med.
Aarhus University Hospital