NOAC9 - Circulating Tumor DNA Guided Follow-Up in Anal Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AMR B: HPV positive ctDNA guided imaging in follow-up.
- Who it may be relevant to
- Registry conditions: Anal Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark, Finland, Norway, Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
NOAC9 - A Phase II Randomised Nordic Anal Cancer Group Study on Circulating Tumor DNA Guided Follow-Up
Overview
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.
Interventions
- Diagnostic test AMR B: HPV positive ctDNA guided imaging in follow-up
Blood samples in follow-up positive for ctDNA leads to an extra PET-CT scan to detect early treatment failure
Primary outcome measures
- Disease free survival [Time frame: after 2 years]
Secondary outcome measures (11)
- Time between ctDNA detected and CT verified recurrences [Time frame: after 5 years]
- Rate of succesful salvage surgery [Time frame: after 5 years]
- Pattern of failure [Time frame: after 5 years]
- Disease free survival at 5 years follow-up [Time frame: after 5 years]
- The rate of distant failures [Time frame: after 5 years]
- Overall survival [Time frame: 5 years]
- Explorative analysis of total circulating free DNA (cfDNA) [Time frame: 5 years]
- ctDNA assays for HPV negative cases [Time frame: 5 years]
- Acute toxicity [Time frame: after 2 and 5 years]
- Late toxicity [Time frame: after 2 and 5 years]
- Health related quality of life [Time frame: after 2 and 5 years]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Norway · 4 centers
- Haukeland University Hospital — Bergen
- Oslo University Hospital — Oslo
- University Hospital of North Norway — Tromsø
- St. Olav's University Hospital — Trondheim
Sweden · 4 centers
- Sahlgrenska University Hospital — Gothenburg
- Skåne University Hospital Lund — Lund
- Karonlinska University Hospital — Stockholm
- Norrlands University Hospital — Umeå
Denmark · 3 centers
- Department of Oncology Herlev and Gentofte Hospital — Herlev
- Department of Oncology, Vejle Hospital — Vejle
- Aarhus University Hospital — Aarhus
Finland · 2 centers
- Tampere University Hospital — Tampere
- Turku University Hospital — Turku
Identifiers
NCT: NCT05572801 · 82386