Shared Decision Making With Anal Cancer Patients on Radiation Dose

Overview

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.

Full Title of Study: “Patient Centered Radiation Treatment of Anal Cancer Using Shared Decision Making as to Dose Level”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2021

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.

Interventions

  • Radiation: 2.15 gray and 1.8 gray. Max. 6 weeks.
  • Radiation: 2.15 gray and 1.8 gray. Max. 5 weeks.

Arms, Groups and Cohorts

  • 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
  • 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
  • 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

Clinical Trial Outcome Measures

Primary Measures

  • 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
  • The fraction of enrolled patients choosing the lower radiation dose
    • Time Frame: 6 months after the last patient has finished radiotherapy

Secondary Measures

  • 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
  • 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
  • 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
  • Quality of life as assessed by combined questionnaires EORTC QLQ CR30 and CR29
    • Time Frame: 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
  • Rate of complete response
    • Time Frame: 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
  • Number of patients with distant metastases at 5 years
    • Time Frame: 5 years after inclusion of the last patient
  • Colostomy free survival
    • Time Frame: 5 years after inclusion of the last patient
  • Disease free survival
    • Time Frame: 5 years after inclusion of the last patient
  • Overall survival
    • Time Frame: 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
  • Response evaluation assessed by diffusion weighted imaging
    • Time Frame: 6 months after the last patient has finished radiotherapy

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Vejle Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Lars H Jensen, MD,PhD, Study Chair, Vejle Hospital
  • Overall Contact(s)
    • Lars H Jensen, MD, PhD, lars.henrik.jensen@rsyd.dk

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