Shared Decision Making With Anal Cancer Patients on Radiation Dose (PC-Anal-01)

July 7, 2025 updated by: Vejle Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study will also provide new knowledge on the effect and side effects of irradiation of anal cancer, and detailed data from the dose planning will be instrumental in optimizing future decision aids.

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Vejle, Denmark, DK-7100
        • Vejle Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Non-resectable metastases
  • 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)
  • Pregnant or breastfeeding women
  • Fertile women not willing to use effective contraception
  • Serious co-morbidity that would hinder interfere with radiation treatment or hinder patient compliance (e.g. incapacity to understand or complete questionnaires)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Standard radiotherapy
Daily on weekdays: 2.15 gray for tumor and verified lymph node metastases and 1.8 gray for the elective volume. A total of 28 treatments
Radiation: 2.15 gray and 1.8 gray. Max. 6 weeks.
Other: High dose radiotherapy
Daily on weekdays: 2.15 gray for tumor and verified lymph node metastases and 1.8 gray for the elective volume. A total of 28 treatments
Radiation: 2.15 gray and 1.8 gray. Max. 6 weeks.
Other: Low dose radiotherapy
Daily on weekdays: 2.15 gray for tumor and verified lymph node metastases and 1.8 gray for the elective volume. A total of 25 treatments
Radiation: 2.15 gray and 1.8 gray. Max. 5 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The fraction of enrolled patients wanting to take part in the decision making on radiation dose level
Time Frame: 6 months after the last patient has finished radiotherapy
6 months after the last patient has finished radiotherapy
The fraction of enrolled patients choosing the lower radiation dose
Time Frame: 6 months after the last patient has finished radiotherapy
6 months after the last patient has finished radiotherapy

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of patients with a V45Gy of less than 300 cc for the small bowel calculated on the basis of dose plans
Time Frame: 6 months after the last patient has finished radiotherapy
6 months after the last patient has finished radiotherapy
Number of patients with a V35Gy of less than 75% for the bladder calculated on the basis of dose plans
Time Frame: 6 months after the last patient has finished radiotherapy
6 months after the last patient has finished radiotherapy
Number of patients with treatment related adverse events as assessed by healthcare staff based on the common toxicity criteria (CTCAE v.4.0)
Time Frame: 5 years after inclusion of the last patient
5 years after inclusion of the last patient
Quality of life as assessed by combined questionnaires EORTC QLQ CR30 and CR29
Time Frame: 5 years after inclusion of the last patient
5 years after inclusion of the last patient
Subjective symptoms as assessed by LARS score (low anterior resection syndrome)
Time Frame: 5 years after inclusion of the last patient
5 years after inclusion of the last patient
Rate of complete response
Time Frame: 6 months after the last patient has finished radiotherapy
6 months after the last patient has finished radiotherapy
Number of patients with loco-regional recurrence 60 months after end of treatment
Time Frame: 5 years after inclusion of the last patient
5 years after inclusion of the last patient
Number of patients with distant metastases at 5 years
Time Frame: 5 years after inclusion of the last patient
5 years after inclusion of the last patient
Colostomy free survival
Time Frame: 5 years after inclusion of the last patient
5 years after inclusion of the last patient
Disease free survival
Time Frame: 5 years after inclusion of the last patient
5 years after inclusion of the last patient
Overall survival
Time Frame: 5 years after inclusion of the last patient
5 years after inclusion of the last patient
Number of patients with HPV at time of enrollment
Time Frame: 6 months after the last patient has finished radiotherapy
6 months after the last patient has finished radiotherapy
Response evaluation assessed by diffusion weighted imaging
Time Frame: 6 months after the last patient has finished radiotherapy
6 months after the last patient has finished radiotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vejle Hospital

Investigators

  • Study Chair: Lars H Jensen, MD,PhD, Vejle Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2016

Primary Completion (Actual)

June 1, 2021

Study Completion (Actual)

June 1, 2025

Study Registration Dates

First Submitted

May 9, 2016

First Submitted That Met QC Criteria

May 24, 2016

First Posted (Estimated)

May 27, 2016

Study Record Updates

Last Update Posted (Actual)

July 8, 2025

Last Update Submitted That Met QC Criteria

July 7, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PC-Anal-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Anal Cancer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mongolia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe