Skip to main content
OpenTrials
Completed

NCT Number: NCT02785263

Shared Decision Making With Anal Cancer Patients on Radiation Dose

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.

Completed

Looking for future studies?

Notify Me

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

Interventional

Phase

Not applicable

Primary location

Vejle Hospital

Vejle, DK-7100, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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)

Treatment and study plan

2.15 gray and 1.8 gray. Max. 6 weeks.

Radiation

2.15 gray and 1.8 gray. Max. 5 weeks.

Radiation

Primary outcomes

  1. 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

  2. The fraction of enrolled patients choosing the lower radiation dose

    Time frame: 6 months after the last patient has finished radiotherapy

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. Quality of life as assessed by combined questionnaires EORTC QLQ CR30 and CR29

    Time frame: 5 years after inclusion of the last patient

  5. Subjective symptoms as assessed by LARS score (low anterior resection syndrome)

    Time frame: 5 years after inclusion of the last patient

  6. Rate of complete response

    Time frame: 6 months after the last patient has finished radiotherapy

  7. Number of patients with loco-regional recurrence 60 months after end of treatment

    Time frame: 5 years after inclusion of the last patient

  8. Number of patients with distant metastases at 5 years

    Time frame: 5 years after inclusion of the last patient

  9. Colostomy free survival

    Time frame: 5 years after inclusion of the last patient

  10. Disease free survival

    Time frame: 5 years after inclusion of the last patient

  11. Overall survival

    Time frame: 5 years after inclusion of the last patient

  12. Number of patients with HPV at time of enrollment

    Time frame: 6 months after the last patient has finished radiotherapy

  13. Response evaluation assessed by diffusion weighted imaging

    Time frame: 6 months after the last patient has finished radiotherapy

Sponsors and collaborators

Lead sponsor

Vejle Hospital

Other

Registry information

Official study title

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

Acronym: PC-Anal-01

Important dates

Study start
2016
Primary completion
2021
Study completion
2025
First posted
May 27, 2016
Registry last updated
Jul 8, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.