Gynecologic CancerNCT07407179
Quality of Life and Lymphedema After Surgical Treatment of Gynecological Malignancies
A study testing Radical Surgical Treatment for Gynecological Malignancies in people with Gynecologic Cancer, run by Institute of Oncology Ljubljana at 1 site in Slovenia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gynecologic Cancer
- What is being tested?
- Radical Surgical Treatment for Gynecological Malignancies
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Jun 2022to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Gynecologic Cancer
- Being tested
- Radical Surgical Treatment for Gynecological Malignancies
- Keywords
- Gynecologic Cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radical Surgical Treatment for Gynecological MalignanciesProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Radical Surgical Treatment for Gynecological Malignancies |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (before surgery); up to 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start1 Jun 2022
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Oncology Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07407179
- Sponsor's protocol ID
- OI-695-GYN-QOL-2022
- Status last verified
- Feb 2026
- First submitted
- 6 Feb 2026
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life and Lymphedema After Surgical Treatment of Gynecological Malignancies
- ClinicalTrials.gov ID
- NCT07407179
- Acronym / sponsor ID
- OI-695-GYN-QOL-2022
- Conditions
- Gynecologic Cancer
- Keywords
- Gynecologic Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Institute of Oncology LjubljanaUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 12 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgical Treatment Group | Other | Procedure: Radical Surgical Treatment for Gynecological MalignanciesPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radical Surgical Treatment for Gynecological MalignanciesRadical 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. | Procedure or surgery | Surgical Treatment Group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radical Surgical Treatment for Gynecological Malignancies in people with Gynecologic Cancer, run by Institute of Oncology Ljubljana at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life After Radical Surgical Treatment of Gynecological Malignancies (EORTC QLQ-C30) (time frame: Baseline (before surgery); up to 6 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.