Clinical trial · Interventional
Shared Decision Making With Anal Cancer Patients on Radiation Dose
Patient Centered Radiation Treatment of Anal Cancer Using Shared Decision Making as to Dose Level
NCT02785263CI-TRIAL-00091843PC-Anal-01completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anal Cancer | Malignant Anal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 2.15 gray and 1.8 gray. Max. 5 weeks. | Radiation | — | UNRESOLVED |
| 2.15 gray and 1.8 gray. Max. 6 weeks. | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- OTHER
- label
- Standard radiotherapy
- description
- 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
- interventionNames
- Radiation: 2.15 gray and 1.8 gray. Max. 6 weeks.
- type
- OTHER
- label
- High dose radiotherapy
- description
- 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
- interventionNames
- Radiation: 2.15 gray and 1.8 gray. Max. 6 weeks.
- type
- OTHER
- label
- Low dose radiotherapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.