Clinical trial · Observational
Anal Cancer Radiotherapy Study
Anal Cancer Radiotherapy - Prospective Study of Treatment Outcome, Patient-Reported Outcomes, Utility of Imaging and Biomarkers, and Cancer Survivorship
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anal Cancer | Malignant Anal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Disease-free survival
- timeFrame
- 3 years
Secondary outcomes (4)
- measure
- Prediction of local recurrence
- timeFrame
- 2 years
- measure
- Biomarker ability to predict local recurrence rate
- timeFrame
- 5 years
- description
- Substudy will analyze biomarkers in tissue/blood that may predict poor radiotherapy response or local recurrence.
- measure
- Improvement of faecal incontinence
- timeFrame
- 5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDHanekamp 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. PMID 41768146