Clinical trial NCT05572801: NOAC9 - Circulating Tumor DNA Guided Follow-Up in Anal Cancer
Official title: NOAC9 - A Phase II Randomised Nordic Anal Cancer Group Study on Circulating Tumor DNA Guided Follow-Up
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anal Cancer
Keywords: Anal cancer
Circulating Tumor DNA
Plasma HPV
Follow-up
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
Collaborators: name: Danish Comprehensive Cancer Center
name: Nordic Cancer Union
name: The regions medicine- and treatment funds
First posted: 2022-10-10
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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

1. To detect lack of complete response to primary treatment
2. Early detection of local or distant recurrences
3. Describing and managing late morbidity

Purpose:

The main purpose of this follow-up study is to investigate if circulating tumor tDNA can improve detection of early treatment failure or recurrences thereby assisting in increasing the potential for cure. Secondly, to provide evidence for use of imaging and third objective is to establish early intervention against late morbidities.

Eligibility criteria: 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.

Primary outcomes:
measure: Disease free survival
timeFrame: after 2 years
Secondary outcomes:
measure: Time between ctDNA detected and CT verified recurrences
timeFrame: after 5 years
measure: Rate of succesful salvage surgery
timeFrame: after 5 years
measure: Pattern of failure
timeFrame: after 5 years
measure: Disease free survival at 5 years follow-up
timeFrame: after 5 years
measure: The rate of distant failures
timeFrame: after 5 years
measure: Overall survival
timeFrame: 5 years
measure: Explorative analysis of total circulating free DNA (cfDNA)
timeFrame: 5 years
measure: ctDNA assays for HPV negative cases
timeFrame: 5 years
measure: Acute toxicity
timeFrame: after 2 and 5 years
measure: Late toxicity
timeFrame: after 2 and 5 years
measure: Health related quality of life
timeFrame: after 2 and 5 years
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Department of Oncology Herlev and Gentofte Hospital
state: Capital Region Of Denmark
city: Vejle
country: Denmark
facility: Department of Oncology, Vejle Hospital
state: The Regions Of Southern Denmark
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Tampere
country: Finland
facility: Tampere University Hospital
city: Turku
country: Finland
facility: Turku University Hospital
city: Bergen
country: Norway
facility: Haukeland University Hospital
city: Oslo
country: Norway
facility: Oslo University Hospital
city: Tromsø
country: Norway
facility: University Hospital of North Norway
city: Trondheim
country: Norway
facility: St. Olav's University Hospital
city: Göteborg
country: Sweden
facility: Sahlgrenska University Hospital
city: Lund
country: Sweden
facility: Skåne University Hospital Lund
city: Stockholm
country: Sweden
facility: Karonlinska University Hospital
city: Umeå
country: Sweden
facility: Norrlands University Hospital
Study officials:
affiliation: Department of Experimental Clinical Oncology Aarhus Univeristy Hospital
name: Karen-Lise G Spindler, Professor
role: PRINCIPAL_INVESTIGATOR
References: