Anal Cancer
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Oslo University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically verified anal squamous cell carcinoma * Radiotherapy or chemoradiotherapy planned * ECOG performance status 0-2 * \>= 18 years of age * Signed informed consent and expected cooperation of the patients for treatment and follow up
Exclusion criteria
\- Cognitive or physical condition resulting in inability to sign informed consent or cooperation during treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-free survival | 3 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prediction of local recurrence | 2 years | — |
| Biomarker ability to predict local recurrence rate | 5 years | Substudy will analyze biomarkers in tissue/blood that may predict poor radiotherapy response or local recurrence. |
| Improvement of faecal incontinence | 5 years | — |
| Pain relief of palliative radiotherapy | 5 years | Substudy will prospectively evaluate relief of pain and other symptoms of anal cancer after completion of palliative radiotherapy. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Local recurrence rate | 5 years | — |
| Tumor regression | 5 years | — |
| Overall survival | 5 years | — |
| Disease-free survival | 5 years | — |
| PET and MRI prediction of local tumor control | 5 years | Substudy will analyze PET and MRI at baseline and during treatment, for the ability to predict poor radiotherapy response or local recurrence rate. |
| 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 | — |
Countries
Norway
Outcome results
None listed