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

Anal Cancer Clinical Trial

Official title:

NOAC9 - A Phase II Randomised Nordic Anal Cancer Group Study on Circulating Tumor DNA Guided Follow-Up

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05572801
• Other study ID #: 82386
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: June 1, 2031

Study information

• Verified date: October 2022
• Source: Aarhus University Hospital
• Contact: Karen-Lise G Spindler, Professor
• Phone: 91137244
• Email: k.g.spindler[@]rm.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: June 1, 2031
• Est. primary completion date: June 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anal Cancer
• Anus Neoplasms

Intervention

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

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus
Denmark	Department of Oncology Herlev and Gentofte Hospital	Herlev	Capital Region Of Denmark
Denmark	Department of Oncology, Vejle Hospital	Vejle	The Regions Of Southern Denmark
Finland	Tampere University Hospital	Tampere
Finland	Turku University Hospital	Turku
Norway	Haukeland University Hospital	Bergen
Norway	Oslo University Hospital	Oslo
Norway	University Hospital of North Norway	Tromsø
Norway	St. Olav's University Hospital	Trondheim
Sweden	Sahlgrenska University Hospital	Göteborg
Sweden	Skåne University Hospital Lund	Lund
Sweden	Karonlinska University Hospital	Stockholm
Sweden	Norrlands University Hospital	Umeå

Sponsors (4)

Lead Sponsor	Collaborator
Aarhus University Hospital	Danish Comprehensive Cancer Center, Nordic Cancer Union, The regions medicine- and treatment funds

Countries where clinical trial is conducted

Denmark,  Finland,  Norway,  Sweden, 

Outcome

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