Quality of Life and Lymphedema After Surgical Treatment of Gynecological Malignancies

NCT07407179 | Completed

• 1 other identifier: OI-695-GYN-QOL-2022
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Gynecologic Cancer

Keywords

Gynecologic Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Surgical Treatment Group

OTHER

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

Interventions

Radical Surgical Treatment for Gynecological Malignancies PROCEDURE

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.

Surgical Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute of Oncology Ljubljana: lead

Study Sites (1)

Institute of Oncology Ljubljana

Ljubljana, 1000, Slovenia

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2026
• First Posted: February 12, 2026
• Study Start: June 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)