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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard radiotherapy | Other | 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 |
|
| High dose radiotherapy | Other | 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 |
|
| Low dose radiotherapy | Other | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2.15 gray and 1.8 gray. Max. 6 weeks. | Radiation |
| ||
| 2.15 gray and 1.8 gray. Max. 5 weeks. |
| 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 |
| 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 |
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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:
Curative intent radiation treatment deemed possible
Patients chooses 1 of 3 options:
Written and orally informed consent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lars H Jensen, MD,PhD | Vejle Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vejle Hospital | Vejle | DK-7100 | Denmark |
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| ID | Term |
|---|---|
| D001005 | Anus Neoplasms |
| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
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| Radiation |
|
| 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 |
| D004067 |
| Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D001004 | Anus Diseases |
| D012002 | Rectal Diseases |