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This is a prospective study of patients receiving radiotherapy or chemoradiotherapy for anal cancer. Treatment effect in terms of survival and local recurrence will be analyzed. The utility of PET-CT and MRI for radiotherapy and for prediction of treatment effect will be investigated. Molecular and genetic markers in tumor and blood will be analyzed for prognostic and predictive effects. Patient-reported outcomes, such as faecal incontinence, sexual dysfunction and quality of life will be assessed. A structured intervention program for management of late effects will be evaluated. Symptom relief of palliative radiotherapy will be investigated. The main purpose of the study is to increase the knowledge of anal cancer treatment, improve treatment results, and improve anal cancer survivor care.
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| Measure | Description | Time Frame |
|---|---|---|
| Disease-free survival | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Prediction of local recurrence | 2 years | |
| Biomarker ability to predict local recurrence rate | Substudy will analyze biomarkers in tissue/blood that may predict poor radiotherapy response or local recurrence. |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor regression | 5 years | |
| PET and MRI prediction of local tumor control | Substudy will analyze PET and MRI at baseline and during treatment, for the ability to predict poor radiotherapy response or local recurrence rate. |
Inclusion Criteria:
Exclusion Criteria:
- Cognitive or physical condition resulting in inability to sign informed consent or cooperation during treatment
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Patients with anal cancer to be treated with radiotherapy or chemoradiotherapy
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| Name | Affiliation | Role |
|---|---|---|
| Marianne G Guren, MD, PhD | Oslo University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oslo University Hospital | Oslo | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41768146 | Derived | Hanekamp BA, Viktil E, Dormagen JB, Klow NE, Brunborg C, Malinen E, Guren MG, Schulz A. Optimal time for MRI response evaluation in squamous cell carcinoma of the anus. BJR Open. 2026 Feb 11;8(1):tzag004. doi: 10.1093/bjro/tzag004. eCollection 2026 Jan. |
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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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Tissue and blood specimens
| 5 years |
| Improvement of faecal incontinence | 5 years |
| Pain relief of palliative radiotherapy | Substudy will prospectively evaluate relief of pain and other symptoms of anal cancer after completion of palliative radiotherapy. | 5 years |
| 5 years |
| To identify biomarkers predictive of treatment response or late effects | 5 years |
| Prevalence and severity of late effects in follow-up; fatigue, faecal incontinence, sexual dysfunction, health-related quality of life. Effect of intervention. | 5 years |
| Duration of symptom relief of palliative radiotherapy | 5 years |
| Local recurrence rate | 5 years |
| Disease-free survival | 5 years |
| Overall survival | 5 years |
| 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 |