Quality of Life and Lymphedema After Surgical Treatment of Gynecological Malignancies
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Quality of Life After Radical Surgical Treatment of Gynecological Malignancies (EORTC QLQ-C30)
Study Overview
Brief Summary
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.
Detailed Description
This is a prospective cohort study designed to evaluate setup errors and intrafractional motion in patients undergoing stereotactic body radiotherapy (SBRT) for lung tumors. SBRT is a highly precise, image-guided form of hypofractionated radiotherapy in which high radiation doses are delivered in 1-8 fractions. Due to the high daily dose per fraction, accurate patient positioning and motion management are essential.
At the Institute of Oncology Ljubljana, lung SBRT has been performed since 2016 using a standard PTV margin of 0.5 cm, based on published literature. However, setup accuracy and residual positioning errors may depend on local clinical workflow, imaging verification protocols, and characteristics of the simulation and treatment equipment. Therefore, it is necessary to evaluate institution-specific setup uncertainties and verify whether the current margin remains appropriate.
The study will include consecutive patients treated with lung SBRT on three treatment machines (Ap4, Ap6, and Ap7). Two immobilization methods will be evaluated: a vacuum cushion and a long thermoplastic mask. For each treatment fraction, CBCT imaging will be performed before treatment, after online correction (residual setup error), and after treatment delivery (intrafractional motion). Setup errors and motion data will be recorded for analysis.
The primary outcomes will be systematic and random setup errors, residual intrafractional error, and calculation of an appropriate PTV margin for each machine and immobilization method using a modified van Herk formula. The study will also evaluate whether the current clinical workflow could be safely shortened by reducing the frequency of CBCT imaging.
The results of this study may support optimization of local SBRT protocols and improve efficiency while maintaining patient safety and treatment accuracy.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Surgical Treatment Group
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.
Intervention: Radical Surgical Treatment for Gynecological Malignancies (Procedure)
Outcomes
Primary Outcomes
Quality of Life After Radical Surgical Treatment of Gynecological Malignancies (EORTC QLQ-C30)
Time Frame: Baseline (before surgery); up to 6 months after surgery
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.
Secondary Outcomes
No secondary outcomes reported