Shared Decision Making With Anal Cancer Patients on Radiation Dose
NCT ID: NCT02785263
Last Updated: 2025-07-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
27 participants
INTERVENTIONAL
2016-06-30
2025-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard radiotherapy
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
2.15 gray and 1.8 gray. Max. 6 weeks.
High dose radiotherapy
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
2.15 gray and 1.8 gray. Max. 6 weeks.
Low dose radiotherapy
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
2.15 gray and 1.8 gray. Max. 5 weeks.
Interventions
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2.15 gray and 1.8 gray. Max. 6 weeks.
2.15 gray and 1.8 gray. Max. 5 weeks.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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Vejle Hospital
OTHER
Responsible Party
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Principal Investigators
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Lars H Jensen, MD,PhD
Role: STUDY_CHAIR
Vejle Hospital
Locations
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Vejle Hospital
Vejle, , Denmark
Countries
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Other Identifiers
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PC-Anal-01
Identifier Type: -
Identifier Source: org_study_id
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