NOAC9 - Circulating Tumor DNA Guided Follow-Up in Anal Cancer

Not Applicable

Recruiting

• Conditions: Anal Cancer

• Registration Number: NCT05572801
• Lead Sponsor: Aarhus University Hospital

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.

Study Timeline

• Study First Submitted: 2022-08-22
• Study First Submitted QC: 2022-10-05
• Study First Posted: 2022-10-10
• Study Start: 2023-08-02
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-13
• Last Update Posted: 2024-08-14
• Primary Completion: 2026-06-01
• Study Completion: 2031-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Disease free survival	after 2 years	Disease free survival 2 years from end of therapy

Secondary Outcome Measures

Name	Time	Method
The rate of distant failures	after 5 years	The rate of distant failures
ctDNA assays for HPV negative cases	5 years	Analysis of ctDNA in HPV negative cases
Health related quality of life	after 2 and 5 years	Health related quality of life (EORTC QLQ-ANL27)
Time between ctDNA detected and CT verified recurrences	after 5 years	Lead time between ctDNA detected and CT verified recurrences
Rate of succesful salvage surgery	after 5 years	Rate of succesful salvage surgery
Pattern of failure	after 5 years	Pattern of failure defined as ln-field failures (within GTV-T, GTV-N, CTV or irradiated areas) or out-of-field failures
Disease free survival at 5 years follow-up	after 5 years	Disease free survival at 5 years follow-up
Explorative analysis of total circulating free DNA (cfDNA)	5 years	Explorative analysis of total circulating free DNA (cfDNA)
Acute toxicity	after 2 and 5 years	Acute toxicity (CTCAE 5.0)
Late toxicity	after 2 and 5 years	Late toxicity (CTCAE 5.0)
Overall survival	5 years	Overall survival from beginning of treatment to death of any cause

Trial Locations

Locations (13)

Tampere University Hospital; 🇫🇮 Tampere, Finland

University Hospital of North Norway; 🇳🇴 Tromsø, Norway

Haukeland University Hospital; 🇳🇴 Bergen, Norway

Oslo University Hospital; 🇳🇴 Oslo, Norway

Skåne University Hospital Lund; 🇸🇪 Lund, Sweden

St. Olav's University Hospital; 🇳🇴 Trondheim, Norway

Karonlinska University Hospital; 🇸🇪 Stockholm, Sweden

Norrlands University Hospital; 🇸🇪 Umeå, Sweden

Department of Oncology Herlev and Gentofte Hospital; 🇩🇰 Herlev, Capital Region Of Denmark, Denmark

Turku University Hospital; 🇫🇮 Turku, Finland

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark

Department of Oncology, Vejle Hospital; 🇩🇰 Vejle, The Regions Of Southern Denmark, Denmark

Sahlgrenska University Hospital; 🇸🇪 Göteborg, Sweden