Shared Decision Making With Anal Cancer Patients on Radiation Dose

Vejle Hospital27 enrolled

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.

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

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Anal Cancer

Interventions

2.15 gray and 1.8 gray. Max. 6 weeks.RADIATION

2.15 gray and 1.8 gray. Max. 5 weeks.RADIATION

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

Vejle Hospital

Vejle, Denmark

Outcomes

Primary Outcomes

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 Outcomes

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

Data from ClinicalTrials.gov

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