Clinical trial · Interventional
Quality of Life and Lymphedema After Surgical Treatment of Gynecological Malignancies
- 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)
This prospective clinical study evaluates the accuracy of the currently used planning target volume (PTV) safety margin of 0.5 cm for stereotactic body radiotherapy (SBRT) of lung tumors at the Institute of Oncology Ljubljana. The study will assess setup errors and intrafractional motion using cone beam CT (CBCT) imaging in patients treated on three linear accelerators and with two different immobilization systems (vacuum cushion and long thermoplastic mask). Based on the collected data, the study aims to determine whether the current PTV margin is adequate and whether the SBRT setup protocol could be optimized.
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 |
|---|---|---|---|
| Gynecologic Cancer | Malignant Female Reproductive System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radical Surgical Treatment for Gynecological Malignancies | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Surgical Treatment Group
- description
- Patients undergoing radical surgical treatment for gynecological malignancies (endometrial, cervical, ovarian, and fallopian tube cancer) will be assessed for quality of life and lower limb lymphedema after treatment.
- interventionNames
- Procedure: Radical Surgical Treatment for Gynecological Malignancies
Primary outcomes (1)
- measure
- Quality of Life After Radical Surgical Treatment of Gynecological Malignancies (EORTC QLQ-C30)
- timeFrame
- Baseline (before surgery); up to 6 months after surgery
- description
- Quality of life will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Scores range from 0 to 100. For the Global Health Status/Quality of Life and functional scales, higher scores indicate better quality of life/functioning, while for symptom scales higher scores indicate worse symptom burden. The outcome will be reported as change in score from baseline.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Female patients aged ≥18 years * Diagnosed with gynecological malignancy (endometrial cancer, cervical cancer, ovarian cancer, or fallopian tube cancer) * Undergoing radical surgical treatment * Ability to complete quality-of-life questionnaires * Signed informed consent Exclusion Criteria: * Age \<18 years * Patients who do not undergo surgical treatment * Inability to complete questionnaires due to cognitive impairment or language barriers * Refusal or inability to provide informed consent
References
Publications (0)
Data not yet available