Clinical Trial: Shared Decision Making With Anal Cancer Patients on Radiation Dose

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: Vejle Hospital

Current Primary Outcome:

  • 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 ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome:

  • 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 af inclusion of the last patient ]
  • Quality of life as assessed by combined questionnaires EORTC QLQ CR30 and CR29 [ Time Frame: 5 years af inclusion of the last patient ]
  • Subjective symptoms as assessed by LARS score (low anterior resection syndrome) [ Time Frame: 5 years af 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 af inclusion of the last patient ]
  • Number of patients with distant metastases at 5 years [ Time Frame: 5 years af 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 ]


Information By: Vejle Hospital

Dates:
Date Received: May 9, 2016
Date Started: April 2016
Date Completion: September 2023
Last Updated: December 14, 2016
Last Verified: December 2016