Pelvic TumorPRoARTNCT06185062
Pelvic Cancer Registry for Online Adapted Radiotherapy
An observational study of Pelvic Tumor and Thoracic Tumor, run by University Medical Center Goettingen at 1 site in Germany.
Trial summary
This prospective registry-based trial will include patients with pelvic or thoracic tumors with an indication for radiotherapy treated with oART or IGRT. For the primary endpoint and the secondary clinical endpoints, the trial will compare oART versus IGRT, for technical endpoints the trial will compare the real oART… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pelvic Tumor, Thoracic Tumor
- How many people
- 846 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2024to Apr 2030
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will include patients with pelvic or thoracic tumors with an indication for radiotherapy treated with oART or IGRT.
Who may be able to join
- Patients with pelvic or thoracic tumors with an indication for radiotherapy
- Patient information and declaration of consent
- Patients age ≥ 18 years
Who cannot join
- Prior radiotherapy in affected site
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Rami El Shafie contact
Germany1 site, 1 recruiting
- Recruiting
University Medical Center, Departement of Radiation Oncology
Göttingen
Laura Anna Fischer, laura-anna.fischer@med.uni-goettingen.de
About this study
Official title: Pelvic and Thoracic Cancer Treated With Online Adapted Radiotherapy: A Prospective Registry-based Phase-II Trial
This prospective registry-based trial will include patients with pelvic or thoracic tumors with an indication for radiotherapy treated with oART or IGRT. For the primary endpoint and the secondary clinical endpoints, the trial will compare oART versus IGRT, for technical endpoints the trial will compare the real oART scenario with two virtual (hypothetical) control scenarios.
Primary endpoint:
Read more
- 10% reduction in the rate of acute radiotherapy related toxicity (≥ CTCAE II°, v5.0) using oART
Secondary endpoints:
- Clinical endpoints: Tumor control, late toxicities compared to conventional irradiated patients, quality of life and patient-reported outcomes
- Technical endpoints: Target volume, target coverage, dose to organs at risk, anatomical variability score
Read the detailed description
Background: Conventional Radiotherapy (Image Guided Radiotherapy, IGRT) requires a CT-based treatment planning process a priori. During this process, a treatment plan is calculated, which then is applied to the patient with a linear accelerator on a daily basis, possibly using image guidance to account for variability in patient position. However, daily changes of the anatomy of targets and organs at risk (OARs) can only be addressed by applying additional safety margins, resulting in larger irradiated volumes and possibly higher toxicity.
A promising and innovative technique for margin and in consequence toxicity reduction is online Adaptive Radiotherapy (oART) using daily imaging to create a "plan of the day" aligned to the actual anatomy by means of artificial intelligence (AI) and with the patient on the treatment couch. This approach is especially promising in the pelvic region due to the high anatomic variability, e.g. caused by peristalsis or volume changes of bladder and rectum. Furthermore, the application of oART in the field of thoracic tumors is being evaluated. oART is an already established form of treatment which is used regulary everyday in clinical practice and is not a study-related intervention. A direct comparison of both techniques IGRT vs. oART is missing.
Methods: This prospective and retrospective registry-based trial will include patients with pelvic or thoracic tumors with an indication for radiotherapy treated with oART or IGRT. For the primary endpoint and the secondary clinical endpoints, the trial will compare oART versus IGRT, for technical endpoints the trial will compare the real oART scenario with two virtual (hypothetical) control scenarios as follows:
- oART - Applied treatment: AI-based daily treatment plan creation, adapted to daily anatomy
- Virt 1 - Hypothetical dose distribution of initial treatment plan, based on the initial planning CT
- Virt 2 - Hypothetical dose distribution of initial treatment plan, applied to the anatomy of the day as depicted by cone-beam CT at the treatment machine
- Conditions
- Pelvic Tumor, Thoracic Tumor
- Keywords
- online Adaptive Radiotherapy
- Medical subject headings
- Pelvic Neoplasms, Thoracic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| oART | Patients with pelvic or thoracic tumors with an indication for radiotherapy treated with oART (online Adaptied Radiotherapy). | |
| IGRT | Patients with pelvic or thoracic tumors with an indication for radiotherapy treated with conventional IGRT (Image Guided Radiotherapy). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of acute radiotherapy related toxicity
10% reduction in the rate of acute radiotherapy related toxicity (≥ CTCAE II°, v5.0) using oART
Measured: until 12 weeks post RT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2023
- Study start1 Jan 2024
- Primary completionSep 2029 (estimated)
- Study completionApr 2030 (estimated)
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 Pelvic 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 846 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- University Medical Center Goettingen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Rami El Shafie, University Medical Center Goettingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06185062
- Sponsor's protocol ID
- 2023-02727
- Other IDs
- 2023
- Acronym
- PRoART
- Status last verified
- Feb 2024
- First submitted
- 14 Dec 2023
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fischer LA, Fischer J, Scheele NC, Droege LH, Leu M, Guhlich M, Oelmann-Avendano JT, Hille A, Bendrich S, Donath S, Knaus O, Ziegler DA, Zwerenz CM, Anczykowski MZ, Ammon HE, Luise Bergau PF, Pagel CF, Schirmer MA, Wenzel AR, Frohn J, Bensberg J, Strauss A, Asendorf T, Schmitt D, Rieken S, El Shafie RA. Online adaptive radiotherapy in pelvic and thoracic cancers - comparing toxicities, clinical outcomes and technical parameters between conventional image-guided radiotherapy and online adaptive radiotherapy - the study protocol for the prospective, registry-based cohort study (PRoART). BMC Med Imaging. 2026 Aug 5;26(1):378. doi: 10.1186/s12880-026-02622-7.
PubMed 42557552
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pelvic and Thoracic Cancer Treated With Online Adapted Radiotherapy: A Prospective Registry-based Phase-II Trial
- ClinicalTrials.gov ID
- NCT06185062
- Acronym / sponsor ID
- PRoART / 2023-02727
- Conditions
- Pelvic Tumor, Thoracic Tumor
- Keywords
- online Adaptive Radiotherapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 846 participants (estimated)
- Lead sponsor
- University Medical Center GoettingenUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Apr 2030 (estimated)
- First posted
- 29 Dec 2023 (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 registry-based trial will include patients with pelvic or thoracic tumors with an indication for radiotherapy treated with oART or IGRT. For the primary endpoint and the secondary clinical endpoints, the trial will compare oART versus IGRT, for technical endpoints the trial will compare the real oART scenario with two virtual (hypothetical) control scenarios.
Primary endpoint:
- 10% reduction in the rate of acute radiotherapy related toxicity (≥ CTCAE II°, v5.0) using oART
Secondary endpoints:
- Clinical endpoints: Tumor control, late toxicities compared to conventional irradiated patients, quality of life and patient-reported outcomes
- Technical endpoints: Target volume, target coverage, dose to organs at risk, anatomical variability score
Detailed description
Background: Conventional Radiotherapy (Image Guided Radiotherapy, IGRT) requires a CT-based treatment planning process a priori. During this process, a treatment plan is calculated, which then is applied to the patient with a linear accelerator on a daily basis, possibly using image guidance to account for variability in patient position. However, daily changes of the anatomy of targets and organs at risk (OARs) can only be addressed by applying additional safety margins, resulting in larger irradiated volumes and possibly higher toxicity.
A promising and innovative technique for margin and in consequence toxicity reduction is online Adaptive Radiotherapy (oART) using daily imaging to create a "plan of the day" aligned to the actual anatomy by means of artificial intelligence (AI) and with the patient on the treatment couch. This approach is especially promising in the pelvic region due to the high anatomic variability, e.g. caused by peristalsis or volume changes of bladder and rectum. Furthermore, the application of oART in the field of thoracic tumors is being evaluated. oART is an already established form of treatment which is used regulary everyday in clinical practice and is not a study-related intervention. A direct comparison of both techniques IGRT vs. oART is missing.
Methods: This prospective and retrospective registry-based trial will include patients with pelvic or thoracic tumors with an indication for radiotherapy treated with oART or IGRT. For the primary endpoint and the secondary clinical endpoints, the trial will compare oART versus IGRT, for technical endpoints the trial will compare the real oART scenario with two virtual (hypothetical) control scenarios as follows:
- oART - Applied treatment: AI-based daily treatment plan creation, adapted to daily anatomy
- Virt 1 - Hypothetical dose distribution of initial treatment plan, based on the initial planning CT
- Virt 2 - Hypothetical dose distribution of initial treatment plan, applied to the anatomy of the day as depicted by cone-beam CT at the treatment machine
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oART | – | –Patients with pelvic or thoracic tumors with an indication for radiotherapy treated with oART (online Adaptied Radiotherapy). |
| IGRT | – | –Patients with pelvic or thoracic tumors with an indication for radiotherapy treated with conventional IGRT (Image Guided Radiotherapy). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will include patients with pelvic or thoracic tumors with an indication for radiotherapy treated with oART or IGRT.
Key inclusion criteria (3 listed)
- Patients with pelvic or thoracic tumors with an indication for radiotherapy
- Patient information and declaration of consent
- Patients age ≥ 18 years
Key exclusion criteria (1 listed)
- Prior radiotherapy in affected site
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of acute radiotherapy related toxicity
Time frame: until 12 weeks post RT
10% reduction in the rate of acute radiotherapy related toxicity (≥ CTCAE II°, v5.0) using oART
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
- Derived from this study: PubMed 42557552Fischer LA, Fischer J, Scheele NC, Droege LH, Leu M, Guhlich M, Oelmann-Avendano JT, Hille A, Bendrich S, Donath S, Knaus O, Ziegler DA, Zwerenz CM, Anczykowski MZ, Ammon HE, Luise Bergau PF, Pagel CF, Schirmer MA, Wenzel AR, Frohn J, Bensberg J, Strauss A, Asendorf T, Schmitt D, Rieken S, El Shafie RA. Online adaptive radiotherapy in pelvic and thoracic cancers - comparing toxicities, clinical outcomes and technical parameters between conventional image-guided radiotherapy and online adaptive radiotherapy - the study protocol for the prospective, registry-based cohort study (PRoART). BMC Med Imaging. 2026 Aug 5;26(1):378. doi: 10.1186/s12880-026-02622-7.
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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.
Rami El Shafie contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Tumor and Thoracic Tumor, run by University Medical Center Goettingen 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 3 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: looking for participants now, as of the sponsor's last update on 8 Feb 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura Anna Fischer (+49 551 3964501, laura-anna.fischer@med.uni-goettingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of acute radiotherapy related toxicity (time frame: until 12 weeks post RT). 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 NCT06185062, 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 8 Feb 2024.