Clinical trial NCT02785263: Shared Decision Making With Anal Cancer Patients on Radiation Dose
Official title: Patient Centered Radiation Treatment of Anal Cancer Using Shared Decision Making as to Dose Level
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Anal Cancer
Keywords: Anal cancer
Shared decision making
Lead sponsor: Vejle Hospital
Sponsor class: OTHER
First posted: 2016-05-27
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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)

Primary outcomes:
measure: The fraction of enrolled patients wanting to take part in the decision making on radiation dose level
timeFrame: 6 months after the last patient has finished radiotherapy
measure: The fraction of enrolled patients choosing the lower radiation dose
timeFrame: 6 months after the last patient has finished radiotherapy
Secondary outcomes:
measure: Number of patients with a V45Gy of less than 300 cc for the small bowel calculated on the basis of dose plans
timeFrame: 6 months after the last patient has finished radiotherapy
measure: Number of patients with a V35Gy of less than 75% for the bladder calculated on the basis of dose plans
timeFrame: 6 months after the last patient has finished radiotherapy
measure: Number of patients with treatment related adverse events as assessed by healthcare staff based on the common toxicity criteria (CTCAE v.4.0)
timeFrame: 5 years after inclusion of the last patient
measure: Quality of life as assessed by combined questionnaires EORTC QLQ CR30 and CR29
timeFrame: 5 years after inclusion of the last patient
measure: Subjective symptoms as assessed by LARS score (low anterior resection syndrome)
timeFrame: 5 years after inclusion of the last patient
measure: Rate of complete response
timeFrame: 6 months after the last patient has finished radiotherapy
measure: Number of patients with loco-regional recurrence 60 months after end of treatment
timeFrame: 5 years after inclusion of the last patient
measure: Number of patients with distant metastases at 5 years
timeFrame: 5 years after inclusion of the last patient
measure: Colostomy free survival
timeFrame: 5 years after inclusion of the last patient
measure: Disease free survival
timeFrame: 5 years after inclusion of the last patient
measure: Overall survival
timeFrame: 5 years after inclusion of the last patient
measure: Number of patients with HPV at time of enrollment
timeFrame: 6 months after the last patient has finished radiotherapy
measure: Response evaluation assessed by diffusion weighted imaging
timeFrame: 6 months after the last patient has finished radiotherapy
Other outcomes:
Locations:
city: Vejle
country: Denmark
facility: Vejle Hospital
Study officials:
affiliation: Vejle Hospital
name: Lars H Jensen, MD,PhD
role: STUDY_CHAIR
References: