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| Name | Class |
|---|---|
| Danish Comprehensive Cancer Center | OTHER |
| Nordic Cancer Union | OTHER |
| The regions medicine- and treatment funds | UNKNOWN |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARM A: HPV positive standard of care follow-up | No Intervention | The national follow-up program + collection of blood samples for retrospective translational research | |
| ARM B: HPV positive ctDNA guided imaging in follow-up | Experimental | The national follow-up program + ctDNA guided additional imaging + collection of blood samples for retrospective translational research |
|
| ARM O: HPV negative observational arm | No Intervention | Patients with HPV negative disease will be included in an observational arm (ARM O) ARM O: The national follow-up program + collection of blood samples for retrospective translational research |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMR B: HPV positive ctDNA guided imaging in follow-up | Diagnostic Test | Blood samples in follow-up positive for ctDNA leads to an extra PET-CT scan to detect early treatment failure |
| Measure | Description | Time Frame |
|---|---|---|
| Disease free survival | Disease free survival 2 years from end of therapy | after 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Time between ctDNA detected and CT verified recurrences | Lead time between ctDNA detected and CT verified recurrences | after 5 years |
| Rate of succesful salvage surgery | Rate of succesful salvage surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Karen-Lise G Spindler, Professor | Contact | 91137244 | k.g.spindler@rm.dk | |
| Louise V Laursen, Secretary | Contact | 78454979 | louise@oncology.au.dk |
| Name | Affiliation | Role |
|---|---|---|
| Karen-Lise G Spindler, Professor | Department of Experimental Clinical Oncology Aarhus Univeristy Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Oncology Herlev and Gentofte Hospital | Recruiting | Herlev | Capital Region of Denmark | 2730 | Denmark |
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| ID | Term |
|---|---|
| D001005 | Anus Neoplasms |
| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
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| 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 | after 5 years |
| Disease free survival at 5 years follow-up | Disease free survival at 5 years follow-up | after 5 years |
| The rate of distant failures | The rate of distant failures | after 5 years |
| Overall survival | Overall survival from beginning of treatment to death of any cause | 5 years |
| Explorative analysis of total circulating free DNA (cfDNA) | Explorative analysis of total circulating free DNA (cfDNA) | 5 years |
| ctDNA assays for HPV negative cases | Analysis of ctDNA in HPV negative cases | 5 years |
| Acute toxicity | Acute toxicity (CTCAE 5.0) | after 2 and 5 years |
| Late toxicity | Late toxicity (CTCAE 5.0) | after 2 and 5 years |
| Health related quality of life | Health related quality of life (EORTC QLQ-ANL27) | after 2 and 5 years |
| Department of Oncology, Vejle Hospital | Recruiting | Vejle | The Regions of Southern Denmark | 7100 | Denmark |
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| Aarhus University Hospital | Recruiting | Aarhus | 8000 | Denmark |
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| Tampere University Hospital | Not yet recruiting | Tampere | 33520 | Finland |
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| Turku University Hospital | Not yet recruiting | Turku | 20521 | Finland |
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| Haukeland University Hospital | Not yet recruiting | Bergen | 5021 | Norway |
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| Oslo University Hospital | Not yet recruiting | Oslo | 0450 | Norway |
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| University Hospital of North Norway | Not yet recruiting | Tromsø | 9019 | Norway |
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| St. Olav's University Hospital | Not yet recruiting | Trondheim | 7030 | Norway |
|
| Sahlgrenska University Hospital | Not yet recruiting | Gothenburg | 413 45 | Sweden |
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| Skåne University Hospital Lund | Not yet recruiting | Lund | 222 42 | Sweden |
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| Karonlinska University Hospital | Not yet recruiting | Stockholm | 171 64 | Sweden |
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| Norrlands University Hospital | Not yet recruiting | Umeå | 907 37 | Sweden |
|
| D004067 |
| Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D001004 | Anus Diseases |
| D012002 | Rectal Diseases |