Lymph Node OligometastasesSTEAL-3NCT07415356
Adaptive Fractionation in Online Adaptive Stereotactic Radiotherapy for Abdominopelvic Lymph Node Oligometastases
A study testing Online-Adaptive SBRT in people with Lymph Node Oligometastases, run by Joost J. M. E. Nuyttens at 1 site in Netherlands.
Trial summary
Oligometastases, a state of cancer with up to five metastases, was traditionally treated with systemic treatments like chemotherapy. Treatment with stereotactic body radiotherapy (SBRT) showed a high local control and improved disease-free survival. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymph Node Oligometastases
- What is being tested?
- Online-Adaptive SBRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteNetherlands
- Study dates
- 27 Feb 2025to 1 Jan 2028
- Phase
- Interventional
- 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
Who may be able to join
- Patients with abdominal and/or pelvic lymph node recurrences of solid tumors.
- No more than 5 metastatic lesions in no more than 2 organs and a controlled primary tumor site.
- Diagnostic imaging includes at least a PET scan or CT thorax/abdomen, of which one is not older than 4 weeks at the time of referral for SBRT.
- Primary tumor must be treated at least 4 months before the diagnosis of metastasis.
- Patients must be 18 years or older.
- Written informed consent.
Who cannot join
- Prior radiotherapy in the same field.
- Second primary malignancy except in situ carcinoma of the cervix, adequately treated non-melanoma skin cancer, or other malignancy treated at least 3 years.
- Serious concomitant systemic disorders that would compromise the safety of the patient or his/her ability to complete the study, at the discretion of the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Erasmus MC
Rotterdam, South Holland, 3015GD
E. van Lieshout, MSc., +31107041538, e.vanlieshout.2@erasmusmc.nl
About this study
Oligometastases, a state of cancer with up to five metastases, was traditionally treated with systemic treatments like chemotherapy. Treatment with stereotactic body radiotherapy (SBRT) showed a high local control and improved disease-free survival.
The use of SBRT also allows for the deferral of systemic treatment, thereby delaying its potential side effects. SBRT enables the delivery of a high dose to the tumor while minimizing the dose to organs at risk, reducing normal tissue damage, however, toxicity remains a potential issue in the abdominopelvic region, where lymph node oligometastases are often located near highly mobile, radiosensitive organs like the bowel.
Read more
Online adaptive radiotherapy is used to address this issue, adapting the treatment plan to the anatomy of the day. Unfortunately, adaptive radiotherapy results in longer treatment delivery times than conventional radiotherapy. This can potentially be countered by increasing the fraction dose and reducing the number of fractions if the patient anatomy allows it. This is convenient for the patient as it reduces the number of hospital visits, and it could also reduce the total workload for the hospital.
Therefore, there is not only a benefit of a reduction in toxicity by adaptive treatment, but also in reducing the total treatment time. This study aims to investigate if the number of adaptive fractions can be reduced by 30% for patients with abdominal or pelvic lymph node oligometastases.
- Conditions
- Lymph Node Oligometastases
- Being tested
- Online-Adaptive SBRT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online-Adaptive SBRTRadiation
The treatment will consist of online-adaptive SBRT using the ETHOS linear accelerator. The standard treatment will be 45 Gy in 5 fractions (45Gy/5Fx). If the patient anatomy allows, the number of planned fractions will be isotoxically reduced, keeping OAR and target dose goals biologically equivalent, to a minimum of 25 Gy in 1 fraction (25Gy/1Fx).
For the adaptive treatment, daily HyperSight CBCT scans will be made, and the target and OAR contours will be automatically delineated and adjusted if necessary. If, during treatment, patient anatomy changes in such a way that fewer or more fractions are required than planned, changes can be made in the daily dose and number of remaining fractions.
During and after treatment, a CBCT scan is made to verify the current treatment and improve future treatments.
| Study group | Role | What they receive |
|---|---|---|
| Online-Adaptive SBRT | Experimental | Not described Receives: Radiation: Online-Adaptive SBRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants achieving ≥30% reduction in number of online-adaptive fractions compared with the standard 5-fraction SBRT course.
For each participant, the number of online-adaptive fractions actually delivered will be recorded. The reduction will be calculated as: (standard - delivered) / standard * 100%.
Measured: From enrollment to the end of treatment at 1 month.
Secondary outcomes (6)
Overall survival (time-to-event in months) from start of SBRT
Time from first SBRT fraction to death from any cause; participants alive at analysis are censored at the date last known alive.
Measured: From first day of treatment up to 48 months.
Local control at the treated site assessed by RECIST v1.1
Proportion of treated lesions without local progression per RECIST v1.1 on protocol imaging.
Measured: At 12, 24, and 36 months after treatment.
Participants with treatment-related acute adverse events (CTCAE v5.0)
Number of participants with any treatment-related adverse event per CTCAE v5.0 occurring during treatment or within 90 days after the last fraction.
Measured: From first day of treatment to 90 days after last fraction.
Participants with treatment-related late adverse events (CTCAE v5.0)
Number of participants with any treatment-related adverse event per CTCAE v5.0 occurring >90 days after the last fraction.
Measured: >90 days after last fraction to 24 months.
Magnitude of intra- and interfraction bowel displacement on CBCT (mm)
Displacement quantified on daily CBCT as (a) intrafraction shift between pre- and post-treatment CBCT and (b) interfraction shift between consecutive pre-treatment CBCTs. Summaries will include, but are not limited to: per-fraction mean and maximum displacement per participant.
Measured: Assessed at each delivered fraction from the first fraction through the final delivered fraction (up to 5 fractions over up to 2 weeks).
Treatment fractions requiring patient re-alignment due to intrafraction motion (CBCT-guided adaptive workflow)
Number of delivered fractions in which treatment is paused and patient re-aligned based on the surface scanning system guidance criteria defined in the clinical workflow.
Measured: Assessed at each delivered fraction from the first fraction through the final delivered fraction (up to 5 fractions over up to 2 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start27 Feb 2025
- Primary completion5 Feb 2026
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymph Node OligometastasesStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Joost J. M. E. Nuyttens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Joost J. M. E. Nuyttens, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07415356
- Sponsor's protocol ID
- NL-OMON57107
- Acronym
- STEAL-3
- Status last verified
- Feb 2026
- First submitted
- 12 Jan 2026
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified Individual Participant Data (IPD) underlying the results of this study will be shared with qualified researchers. All shared data will be coded and stripped of personal health information (PHI). Approval of the data request and execution of all required agreements (e.g., Data Sharing Agreement) will be required prior to release.
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptive Fractionation in Online Adaptive Stereotactic Radiotherapy for Abdominopelvic Lymph Node Oligometastases
- ClinicalTrials.gov ID
- NCT07415356
- Acronym / sponsor ID
- STEAL-3 / NL-OMON57107
- Conditions
- Lymph Node Oligometastases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Joost J. M. E. NuyttensUniversity, hospital or other
- Study start
- 27 Feb 2025 (actual)
- Primary completion
- 5 Feb 2026 (actual)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 17 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.
Oligometastases, a state of cancer with up to five metastases, was traditionally treated with systemic treatments like chemotherapy. Treatment with stereotactic body radiotherapy (SBRT) showed a high local control and improved disease-free survival.
The use of SBRT also allows for the deferral of systemic treatment, thereby delaying its potential side effects. SBRT enables the delivery of a high dose to the tumor while minimizing the dose to organs at risk, reducing normal tissue damage, however, toxicity remains a potential issue in the abdominopelvic region, where lymph node oligometastases are often located near highly mobile, radiosensitive organs like the bowel.
Online adaptive radiotherapy is used to address this issue, adapting the treatment plan to the anatomy of the day. Unfortunately, adaptive radiotherapy results in longer treatment delivery times than conventional radiotherapy. This can potentially be countered by increasing the fraction dose and reducing the number of fractions if the patient anatomy allows it. This is convenient for the patient as it reduces the number of hospital visits, and it could also reduce the total workload for the hospital.
Therefore, there is not only a benefit of a reduction in toxicity by adaptive treatment, but also in reducing the total treatment time. This study aims to investigate if the number of adaptive fractions can be reduced by 30% for patients with abdominal or pelvic lymph node oligometastases.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Online-Adaptive SBRT | Experimental | Radiation: Online-Adaptive SBRT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with abdominal and/or pelvic lymph node recurrences of solid tumors.
- No more than 5 metastatic lesions in no more than 2 organs and a controlled primary tumor site.
- Diagnostic imaging includes at least a PET scan or CT thorax/abdomen, of which one is not older than 4 weeks at the time of referral for SBRT.
- Primary tumor must be treated at least 4 months before the diagnosis of metastasis.
- Patients must be 18 years or older.
Key exclusion criteria (3 listed)
- Prior radiotherapy in the same field.
- Second primary malignancy except in situ carcinoma of the cervix, adequately treated non-melanoma skin cancer, or other malignancy treated at least 3 years.
- Serious concomitant systemic disorders that would compromise the safety of the patient or his/her ability to complete the study, at the discretion of the investigator.
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 |
|---|---|---|
| Online-Adaptive SBRTThe treatment will consist of online-adaptive SBRT using the ETHOS linear accelerator. The standard treatment will be 45 Gy in 5 fractions (45Gy/5Fx). If the patient anatomy allows, the number of planned fractions will be isotoxically reduced, keeping OAR and target dose goals biologically equivalent, to a minimum of 25 Gy in 1 fraction (25Gy/1Fx). For the adaptive treatment, daily HyperSight CBCT scans will be made, and the target and OAR contours will be automatically delineated and adjusted if necessary. If, during treatment, patient anatomy changes in such a way that fewer or more fractions are required than planned, changes can be made in the daily dose and number of remaining fractions. During and after treatment, a CBCT scan is made to verify the current treatment and improve future treatments. | Radiation | Online-Adaptive SBRT |
Primary outcome
Proportion of participants achieving ≥30% reduction in number of online-adaptive fractions compared with the standard 5-fraction SBRT course.
Time frame: From enrollment to the end of treatment at 1 month.
For each participant, the number of online-adaptive fractions actually delivered will be recorded. The reduction will be calculated as: (standard - delivered) / standard * 100%.
6 secondary outcomes
Overall survival (time-to-event in months) from start of SBRT
Time frame: From first day of treatment up to 48 months.
Local control at the treated site assessed by RECIST v1.1
Time frame: At 12, 24, and 36 months after treatment.
Participants with treatment-related acute adverse events (CTCAE v5.0)
Time frame: From first day of treatment to 90 days after last fraction.
Participants with treatment-related late adverse events (CTCAE v5.0)
Time frame: >90 days after last fraction to 24 months.
Magnitude of intra- and interfraction bowel displacement on CBCT (mm)
Time frame: Assessed at each delivered fraction from the first fraction through the final delivered fraction (up to 5 fractions over up to 2 weeks).
Treatment fractions requiring patient re-alignment due to intrafraction motion (CBCT-guided adaptive workflow)
Time frame: Assessed at each delivered fraction from the first fraction through the final delivered fraction (up to 5 fractions over up to 2 weeks).
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 17 Feb 2026.
- Individual participant dataSharing planned: Yes. De-identified Individual Participant Data (IPD) underlying the results of this study will be shared with qualified researchers. All shared data will be coded and stripped of personal health information (PHI). Approval of the data request and execution of all required agreements (e.g., Data Sharing Agreement) will be required prior to release.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online-Adaptive SBRT in people with Lymph Node Oligometastases, run by Joost J. M. E. Nuyttens at 1 site in Netherlands.
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 6 inclusion and 3 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 17 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 Netherlands. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants achieving ≥30% reduction in number of online-adaptive fractions compared with the standard 5-fraction SBRT course. (time frame: From enrollment to the end of treatment at 1 month.). 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 17 Feb 2026.