Anal Cancer
Conditions
Keywords
Anal cancer, Circulating Tumor DNA, Plasma HPV, Follow-up
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.
Interventions
DIAGNOSTIC_TESTAMR 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
Sponsors
Danish Comprehensive Cancer Center
Nordic Cancer Union
The regions medicine- and treatment funds
Aarhus University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease free survival | after 2 years | Disease free survival 2 years from end of therapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| The rate of distant failures | after 5 years | The rate of distant failures |
| Overall survival | 5 years | Overall survival from beginning of treatment to death of any cause |
| Time between ctDNA detected and CT verified recurrences | after 5 years | Lead time between ctDNA detected and CT verified recurrences |
| ctDNA assays for HPV negative cases | 5 years | Analysis of ctDNA in HPV negative cases |
| Acute toxicity | after 2 and 5 years | Acute toxicity (CTCAE 5.0) |
| Late toxicity | after 2 and 5 years | Late toxicity (CTCAE 5.0) |
| Health related quality of life | after 2 and 5 years | Health related quality of life (EORTC QLQ-ANL27) |
| Explorative analysis of total circulating free DNA (cfDNA) | 5 years | Explorative analysis of total circulating free DNA (cfDNA) |
Countries
Denmark, Finland, Norway, Sweden
Contacts
Primary ContactKaren-Lise G Spindler, Professor
Backup ContactLouise V Laursen, Secretary
Outcome results
None listed