Gynecological TumorProARTNCT06230549
Adaptive Radiotherapy in Patients With Gynecological Tumors
A study testing Adaptive Radiotherapy in people with Gynecological Tumor and Adaptive Radiotherapy, run by University Hospital, Essen at 1 site in Germany.
Trial summary
Prospective randomized evaluation of adaptive radiotherapy in the definitive radiotherapy of locally advanced gynecologic carcinoma (e.g. cervical carcinoma, endometrial carcinoma, vaginal carcinoma), in the postoperative situation or first series of external beam radiotherapy and in patients in whom radical surgery… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gynecological Tumor, Adaptive Radiotherapy, Radiation
- What is being tested?
- Adaptive Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 15 Jan 2024to 15 Oct 2026
- 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
- ECOG 0-1 confirmation by histophatology MR of the pelvis staging
Who cannot join
- Recurrent disease Prior Radiotherapy in pelvic region stage pM1 or cM1
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department for Radiotherapy, University Hospital Essen, National Center for Tumor Diseases (NCT) West
Essen, Germany / NRW, 45147
About this study
Official title: Prospective Randomized Validation of Adaptive Radiotherapy in Patients With Gynecological Tumors and Indication for Radiotherapy
Prospective randomized evaluation of adaptive radiotherapy in the definitive radiotherapy of locally advanced gynecologic carcinoma (e.g. cervical carcinoma, endometrial carcinoma, vaginal carcinoma), in the postoperative situation or first series of external beam radiotherapy and in patients in whom radical surgery or HDR brachytherapy as dose boost is not an option.
Read the detailed description
Online-adaptive radiotherapy (ART) makes it possible to adapt the dose distribution to the anatomical changes online immediately before each radiation fraction. Adaptive radiotherapy is a further development of image-guided radiotherapy (IGRT), which is now standard in radiotherapy. Here, a cone-beam CT (CBCT) is also performed at the beginning of each fraction, which is used to position the patients in relation to the radiation field arrangement of the initial radiation plan approved for the series. In contrast to ART, with IGRT the radiation plan cannot be adapted to deformations in the body from radiation fraction to radiation fraction, e.g. due to different rectum and bladder fillings.
In ART mode, the online adaptive treatment plan for the current treatment is then selected and approved by the specialist online onboard in all cases in which the current target volume for the tumor expansion is not sufficiently covered by the initial treatment plan pre-planned for the series with its planned tolerances, or surrounding normal tissue is exposed too much. If the ART plan does not show any clear dosimetric advantages over the reference plan, especially if the initial plan covers the target volume of the day well, there are no dose increases and the normal tissues are spared as intended, the initial radiation plan from the planning CT can also be used as in IGRT. The aim of this study is to treat at least 15 patients with locally advanced gynecological carcinoma (mainly cervical carcinoma, endometrial carcinoma, vaginal carcinoma), who are to receive definitive radiotherapy at the Department for Radiotherapy at the University Hospital Essen, in ART mode on the Ethos therapy device over an initial 10 radiation fractions. The dose distribution is always compared with the adaptive and the initial plan for the radiation series on the anatomy of the day by the specialist and medical physics expert. The aim of this study is to prospectively investigate what percentage of patients benefit from ART when using standard PTV margins and how to recognize the corresponding patients early in the series. Secondarily, it will be investigated in what proportion of patients the risk organ burden and the safety margins around the clinical target volume can be reduced with ART compared to IGRT and how large this reduction can be.
The EORTC and CTC AE toxicitiy scales and further assessment scales will be evaluated in order to quantify objective and subjective side effects.
- Conditions
- Gynecological Tumor, Adaptive Radiotherapy, Radiation, Curative Treatment, Optimization, Adaptive Radiation Therapy
- Being tested
- Adaptive Radiotherapy
- Keywords
- gynecological tumor, adaptive radiotherapy, radiation, curative treatment, optimization, adaptive radiation therapy, image guided radiotherapy, Cervical carcinoma
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adaptive RadiotherapyRadiation
Also called Adaptive Radiation Therapy
Adaptive Radiotherapy, online onboard adaptation of dose distribution with a specialist radiation oncologist and a medical physicist
| Study group | Role | What they receive |
|---|---|---|
| Interventional Arm | Experimental | Adaptive Radiotherapy Receives: Radiation: Adaptive Radiotherapy |
| Standard conventional Treatment Arm, IGRT | Active comparator | Standard conventional Treatment Arm, IGRT Receives: Radiation: Adaptive Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rectal Toxicity
Rectum, EORTC CTC-AE (Common Toxicity Criteria (CTC) of the European Organisation for Research and Treatment of Cancer (EORTC)) 1-5, [score 1: nearly no toxicity, asymptomatic changes - score 5: worst outcome (death)]
Measured: 2 weeks to 5 years
Bladder Toxicity
Bladder, EORTC CTC-AE (Common Toxicity Criteria (CTC) of the European Organisation for Research and Treatment of Cancer (EORTC)) 1-5, [score 1: nearly no toxicity, asymptomatic changes - score 5: worst outcome (death)]
Measured: 2 weeks to 5 years
Skin Toxicity
Skin, EORTC CTC-AE (Common Toxicity Criteria (CTC) of the European Organisation for Research and Treatment of Cancer (EORTC)) 1-5, [score 1: nearly no toxicity, asymptomatic changes - score 5: worst outcome (death)]
Measured: 2 weeks to 5 years
Lymph-Edema grade
Lymph-Edema, EORTC CTC-AE ( (Common Toxicity Criteria (CTC) of the European Organisation for Research and Treatment of Cancer (EORTC)) 1-3, [score 1: nearly no toxicity, asymptomatic changes - score 3: worst outcome, severe symptoms; limiting self care ADL]
Measured: 2 weeks to 5 years
Secondary outcomes (2)
Overall Survival
Overall Survival
Measured: 5 years
Progression Free Survival
Progression Free Survival
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start15 Jan 2024
- Primary completion15 Dec 2025
- Study completion15 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gynecological TumorStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Essen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maja Guberina, University Hospital, Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06230549
- Sponsor's protocol ID
- 23-11675-BO
- Acronym
- ProART
- Status last verified
- Oct 2026
- First submitted
- 30 Dec 2023
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Guberina M, Santiago Garcia A, Khouya A, Pottgen C, Holubyev K, Ringbaek TP, Lachmuth M, Alberti Y, Hoffmann C, Hlouschek J, Gauler T, Lubcke W, Indenkampen F, Stuschke M, Guberina N. Comparison of Online-Onboard Adaptive Intensity-Modulated Radiation Therapy or Volumetric-Modulated Arc Radiotherapy With Image-Guided Radiotherapy for Patients With Gynecologic Tumors in Dependence on Fractionation and the Planning Target Volume Margin. JAMA Netw Open. 2023 Mar 1;6(3):e234066. doi: 10.1001/jamanetworkopen.2023.4066.
PubMed 36947038
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Validation of Adaptive Radiotherapy in Patients With Gynecological Tumors and Indication for Radiotherapy
- ClinicalTrials.gov ID
- NCT06230549
- Acronym / sponsor ID
- ProART / 23-11675-BO
- Conditions
- Gynecological Tumor, Adaptive Radiotherapy, Radiation, Curative Treatment, Optimization, Adaptive Radiation Therapy
- Keywords
- gynecological tumor, adaptive radiotherapy, radiation, curative treatment, optimization, adaptive radiation therapy, image guided radiotherapy, Cervical carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, EssenUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 15 Dec 2025 (actual)
- Study completion
- 15 Oct 2026 (actual)
- First posted
- 30 Jan 2024 (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.
Prospective randomized evaluation of adaptive radiotherapy in the definitive radiotherapy of locally advanced gynecologic carcinoma (e.g. cervical carcinoma, endometrial carcinoma, vaginal carcinoma), in the postoperative situation or first series of external beam radiotherapy and in patients in whom radical surgery or HDR brachytherapy as dose boost is not an option.
Detailed description
Online-adaptive radiotherapy (ART) makes it possible to adapt the dose distribution to the anatomical changes online immediately before each radiation fraction. Adaptive radiotherapy is a further development of image-guided radiotherapy (IGRT), which is now standard in radiotherapy. Here, a cone-beam CT (CBCT) is also performed at the beginning of each fraction, which is used to position the patients in relation to the radiation field arrangement of the initial radiation plan approved for the series. In contrast to ART, with IGRT the radiation plan cannot be adapted to deformations in the body from radiation fraction to radiation fraction, e.g. due to different rectum and bladder fillings.
In ART mode, the online adaptive treatment plan for the current treatment is then selected and approved by the specialist online onboard in all cases in which the current target volume for the tumor expansion is not sufficiently covered by the initial treatment plan pre-planned for the series with its planned tolerances, or surrounding normal tissue is exposed too much. If the ART plan does not show any clear dosimetric advantages over the reference plan, especially if the initial plan covers the target volume of the day well, there are no dose increases and the normal tissues are spared as intended, the initial radiation plan from the planning CT can also be used as in IGRT. The aim of this study is to treat at least 15 patients with locally advanced gynecological carcinoma (mainly cervical carcinoma, endometrial carcinoma, vaginal carcinoma), who are to receive definitive radiotherapy at the Department for Radiotherapy at the University Hospital Essen, in ART mode on the Ethos therapy device over an initial 10 radiation fractions. The dose distribution is always compared with the adaptive and the initial plan for the radiation series on the anatomy of the day by the specialist and medical physics expert. The aim of this study is to prospectively investigate what percentage of patients benefit from ART when using standard PTV margins and how to recognize the corresponding patients early in the series. Secondarily, it will be investigated in what proportion of patients the risk organ burden and the safety margins around the clinical target volume can be reduced with ART compared to IGRT and how large this reduction can be.
The EORTC and CTC AE toxicitiy scales and further assessment scales will be evaluated in order to quantify objective and subjective side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional Arm | Experimental | Radiation: Adaptive RadiotherapyAdaptive Radiotherapy |
| Standard conventional Treatment Arm, IGRT | Active comparator | Radiation: Adaptive RadiotherapyStandard conventional Treatment Arm, IGRT |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ECOG 0-1 confirmation by histophatology MR of the pelvis staging
Key exclusion criteria (1 listed)
- Recurrent disease Prior Radiotherapy in pelvic region stage pM1 or cM1
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 |
|---|---|---|
| Adaptive RadiotherapyAlso: Adaptive Radiation TherapyAdaptive Radiotherapy, online onboard adaptation of dose distribution with a specialist radiation oncologist and a medical physicist | Radiation | Interventional Arm, Standard conventional Treatment Arm, IGRT |
Primary outcome
Rectal Toxicity
Time frame: 2 weeks to 5 years
Rectum, EORTC CTC-AE (Common Toxicity Criteria (CTC) of the European Organisation for Research and Treatment of Cancer (EORTC)) 1-5, [score 1: nearly no toxicity, asymptomatic changes - score 5: worst outcome (death)]
Bladder Toxicity
Time frame: 2 weeks to 5 years
Bladder, EORTC CTC-AE (Common Toxicity Criteria (CTC) of the European Organisation for Research and Treatment of Cancer (EORTC)) 1-5, [score 1: nearly no toxicity, asymptomatic changes - score 5: worst outcome (death)]
Skin Toxicity
Time frame: 2 weeks to 5 years
Skin, EORTC CTC-AE (Common Toxicity Criteria (CTC) of the European Organisation for Research and Treatment of Cancer (EORTC)) 1-5, [score 1: nearly no toxicity, asymptomatic changes - score 5: worst outcome (death)]
Lymph-Edema grade
Time frame: 2 weeks to 5 years
Lymph-Edema, EORTC CTC-AE ( (Common Toxicity Criteria (CTC) of the European Organisation for Research and Treatment of Cancer (EORTC)) 1-3, [score 1: nearly no toxicity, asymptomatic changes - score 3: worst outcome, severe symptoms; limiting self care ADL]
2 secondary outcomes
Overall Survival
Time frame: 5 years
Progression Free Survival
Time frame: 5 years
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 20 Oct 2026.
- Background: PubMed 36947038Guberina M, Santiago Garcia A, Khouya A, Pottgen C, Holubyev K, Ringbaek TP, Lachmuth M, Alberti Y, Hoffmann C, Hlouschek J, Gauler T, Lubcke W, Indenkampen F, Stuschke M, Guberina N. Comparison of Online-Onboard Adaptive Intensity-Modulated Radiation Therapy or Volumetric-Modulated Arc Radiotherapy With Image-Guided Radiotherapy for Patients With Gynecologic Tumors in Dependence on Fractionation and the Planning Target Volume Margin. JAMA Netw Open. 2023 Mar 1;6(3):e234066. doi: 10.1001/jamanetworkopen.2023.4066.
- 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 Adaptive Radiotherapy in people with Gynecological Tumor and Adaptive Radiotherapy, run by University Hospital, Essen at 1 site in Germany.
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 1 inclusion and 1 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 20 Oct 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 Germany. 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?
Rectal Toxicity (time frame: 2 weeks to 5 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06230549, which also lists 1 linked publication.
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 20 Oct 2026.