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Active, Not Recruiting

NCT Number: NCT01937780

Anal Cancer Radiotherapy Study

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Anal Cancer Anus Diseases Anus Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Oslo University Hospital

Oslo, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Disease-free survival

    Time frame: 3 years

Secondary outcomes

  1. Prediction of local recurrence

    Time frame: 2 years

  2. Biomarker ability to predict local recurrence rate

    Time frame: 5 years

    Substudy will analyze biomarkers in tissue/blood that may predict poor radiotherapy response or local recurrence.

  3. Improvement of faecal incontinence

    Time frame: 5 years

  4. Pain relief of palliative radiotherapy

    Time frame: 5 years

    Substudy will prospectively evaluate relief of pain and other symptoms of anal cancer after completion of palliative radiotherapy.

Other outcomes

  1. Tumor regression

    Time frame: 5 years

  2. PET and MRI prediction of local tumor control

    Time frame: 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.

  3. To identify biomarkers predictive of treatment response or late effects

    Time frame: 5 years

  4. Prevalence and severity of late effects in follow-up; fatigue, faecal incontinence, sexual dysfunction, health-related quality of life. Effect of intervention.

    Time frame: 5 years

  5. Duration of symptom relief of palliative radiotherapy

    Time frame: 5 years

  6. Local recurrence rate

    Time frame: 5 years

  7. Disease-free survival

    Time frame: 5 years

  8. Overall survival

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Official study title

Anal Cancer Radiotherapy - Prospective Study of Treatment Outcome, Patient-Reported Outcomes, Utility of Imaging and Biomarkers, and Cancer Survivorship

Acronym: ANCARAD

Important dates

Study start
2013
Primary completion
2022
Study completion
2025
First posted
Sep 10, 2013
Registry last updated
Mar 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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