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NCT02785263Completed

Shared Decision Making With Anal Cancer Patients on Radiation Dose

Patient Centered Radiation Treatment of Anal Cancer Using Shared Decision Making as to Dose Level

Source: ClinicalTrials.gov · Last updated 8 Jul 2025

Brief summary (registry, in English)

The purpose of this study is to maximize patient involvement in the treatment of anal cancer. Specifically, the investigators will investigate whether patients wish to take part in the decision making on radiation dose and whether they want a high or low radiation dose.

Status (registry)
Completed
Study type
Interventional
Enrollment
27 (actual)
First submitted
9 May 2016
Start date
1 Jun 2016
Primary completion date
30 Jun 2021
Lead sponsor
Vejle Hospital
NCT number
NCT02785263

What you commit to

  • Study type: Interventional
  • Participants enrolled: 27
  • From 1 Jun 2016 to the primary completion date, 30 Jun 2021
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Tumor \> 10 cm or the total tumor volume (incl. lymph node metastases) is too large to be included in an appropriate radiation field (after possible neoadjuvant chemotherapy)
  • Serious co-morbidity that would hinder interfere with radiation treatment or hinder patient compliance (e.g. incapacity to understand or complete questionnaires)

Other

  • Non-resectable metastases
  • Pregnant or breastfeeding women
  • Fertile women not willing to use effective contraception

Who the study is looking for

  • Squamous cell carcinoma of the anal duct or perianal (non-hairy skin, max 5 cm from the anal verge)
  • T2-T4 N0-3
  • Age ≥ 18 years
  • Performance status 0-2
  • Sufficient organ and bone marrow function defined as:
    • Neutrophils ≥ 1.5 x 10\^9/L
    • Thrombocytes ≥ 100 x 10\^9/L
  • Curative intent radiation treatment deemed possible
  • Patients chooses 1 of 3 options:
    • I do not wish to decide on details of my treatment, but I would like to receive the standard treatment
    • I want to receive the high radiation dose
    • I want to receive the low radiation dose
  • Written and orally informed consent

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Vejle Hospital
Coordinator of this site? Confirm its status
VejleDenmarkUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.