Quality of Life and Lymphedema After Surgical Treatment of Gynecological Malignancies

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.

Study Overview

• Status: Completed
• Conditions: Gynecologic Cancer
• Intervention / Treatment: Procedure: Radical Surgical Treatment for Gynecological Malignancies

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Slovenia
  • Ljubljana, Slovenia, 1000
    • Institute of Oncology Ljubljana

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Procedure: Radical Surgical Treatment for Gynecological Malignancies; Radical surgical treatment performed as standard of care for gynecological malignancies (endometrial, cervical, ovarian, and fallopian tube cancer), followed by assessment of quality of life and evaluation of lower limb lymphedema.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life After Radical Surgical Treatment of Gynecological Malignancies (EORTC QLQ-C30)	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.	Baseline (before surgery); up to 6 months after surgery

Collaborators and Investigators

• Sponsor: Institute of Oncology Ljubljana

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: February 6, 2026
• First Submitted That Met QC Criteria: February 6, 2026
• First Posted (Actual): February 12, 2026

Study Record Updates

• Last Update Posted (Actual): February 18, 2026
• Last Update Submitted That Met QC Criteria: February 13, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Gynecologic Cancer
• Other Study ID Numbers: OI-695-GYN-QOL-2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No