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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
400
Blood samples in follow-up positive for ctDNA leads to an extra PET-CT scan to detect early treatment failure
Department of Oncology Herlev and Gentofte Hospital
Herlev, Capital Region of Denmark, Denmark
RECRUITINGDepartment of Oncology, Vejle Hospital
Vejle, The Regions of Southern Denmark, Denmark
Disease free survival
Disease free survival 2 years from end of therapy
Time frame: after 2 years
Time between ctDNA detected and CT verified recurrences
Lead time between ctDNA detected and CT verified recurrences
Time frame: after 5 years
Rate of succesful salvage surgery
Rate of succesful salvage surgery
Time frame: after 5 years
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
Time frame: after 5 years
Disease free survival at 5 years follow-up
Disease free survival at 5 years follow-up
Time frame: after 5 years
The rate of distant failures
The rate of distant failures
Time frame: after 5 years
Overall survival
Overall survival from beginning of treatment to death of any cause
Time frame: 5 years
Explorative analysis of total circulating free DNA (cfDNA)
Explorative analysis of total circulating free DNA (cfDNA)
Time frame: 5 years
ctDNA assays for HPV negative cases
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Aarhus University Hospital
Aarhus, Denmark
RECRUITINGTampere University Hospital
Tampere, Finland
NOT_YET_RECRUITINGTurku University Hospital
Turku, Finland
NOT_YET_RECRUITINGHaukeland University Hospital
Bergen, Norway
NOT_YET_RECRUITINGOslo University Hospital
Oslo, Norway
NOT_YET_RECRUITINGUniversity Hospital of North Norway
Tromsø, Norway
NOT_YET_RECRUITINGSt. Olav's University Hospital
Trondheim, Norway
NOT_YET_RECRUITINGSahlgrenska University Hospital
Gothenburg, Sweden
NOT_YET_RECRUITING...and 3 more locations
Analysis of ctDNA in HPV negative cases
Time frame: 5 years
Acute toxicity
Acute toxicity (CTCAE 5.0)
Time frame: after 2 and 5 years
Late toxicity
Late toxicity (CTCAE 5.0)
Time frame: after 2 and 5 years
Health related quality of life
Health related quality of life (EORTC QLQ-ANL27)
Time frame: after 2 and 5 years