Shared Decision Making With Anal Cancer Patients on Radiation Dose

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Anal Cancer

Intervention / Treatment
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* Radiation: 2.15 gray and 1.8 gray. Max. 6 weeks.
* Radiation: 2.15 gray and 1.8 gray. Max. 5 weeks.


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Standard radiotherapy<br>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 | Radiation: 2.15 gray and 1.8 gray. Max. 6 weeks.<br> <br> |
| Other: High dose radiotherapy<br>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 | Radiation: 2.15 gray and 1.8 gray. Max. 6 weeks.<br> <br> |
| Other: Low dose radiotherapy<br>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 | Radiation: 2.15 gray and 1.8 gray. Max. 5 weeks.<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The fraction of enrolled patients wanting to take part in the decision making on radiation dose level |  | 6 months after the last patient has finished radiotherapy | 
| The fraction of enrolled patients choosing the lower radiation dose |  | 6 months after the last patient has finished radiotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with a V45Gy of less than 300 cc for the small bowel calculated on the basis of dose plans |  | 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 |  | 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) |  | 5 years after inclusion of the last patient | 
| Quality of life as assessed by combined questionnaires EORTC QLQ CR30 and CR29 |  | 5 years after inclusion of the last patient | 
| Subjective symptoms as assessed by LARS score (low anterior resection syndrome) |  | 5 years after inclusion of the last patient | 
| Rate of complete response |  | 6 months after the last patient has finished radiotherapy | 
| Number of patients with loco-regional recurrence 60 months after end of treatment |  | 5 years after inclusion of the last patient | 
| Number of patients with distant metastases at 5 years |  | 5 years after inclusion of the last patient | 
| Colostomy free survival |  | 5 years after inclusion of the last patient | 
| Disease free survival |  | 5 years after inclusion of the last patient | 
| Overall survival |  | 5 years after inclusion of the last patient | 
| Number of patients with HPV at time of enrollment |  | 6 months after the last patient has finished radiotherapy | 
| Response evaluation assessed by diffusion weighted imaging |  | 6 months after the last patient has finished radiotherapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anal cancer, Shared decision making