Klatskin TumorSTRONG IINCT06493734
Stereotactic Body Radiation Therapy After Chemotherapy for Unresectable Perihilar Cholangiocarcinoma
A study testing Stereotactic body radiation therapy in people with Klatskin Tumor, run by Erasmus Medical Center at 8 sites in 2 countries.
Trial summary
The objective of this study is to evaluate the efficacy of stereotactic body radiation therapy (SBRT) as additional treatment after standard chemotherapy regarding tumor local control, toxicity, progression-free survival (PFS), overall survival and quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Klatskin Tumor
- What is being tested?
- Stereotactic body radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 1 Jul 2024to 1 Mar 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
- In order to be eligible to participate in the translational part of the study, a subject must be discussed in a liver tumor board, should be eligible for gemcitabine-based chemotherapy (and immunotherapy, if applicable), and should meet all of the following criteria pre-chemotherapy:
- Perihilar cholangiocarcinoma (pCCA) according to the criteria of the Mayo Clinic, Rochester: a positive or strongly suspicious intraluminal brush cytology or biopsy, or a radiographic malignant appearing stricture plus either: CA 19-9>100 U/ml in the absence of acute bacterial cholangitis, or polysomy on fluorescence in situ hybridization (FISH), or a well-defined mass on cross sectional imaging
- One tumor mass
- Unresectable tumor or patient deemed unfit for surgery
- T1-T4 (AJCC staging 8th edition), N0-N2-M0 (AJCC staging 8th edition), radiologically or pathologically suspect. N1 is defined as one to three affected lymph nodes typically involving the hilar, cystic duct, common bile duct, hepatic artery, posterior pancreatoduodenal, and portal vein lymph nodes. N2 is defined as four or more affected lymph nodes from the sites described for N1. Endoscopic ultrasound (EUS) is leading in identifying pathological lymph nodes compared to CT.
- In case of (underlying) liver cirrhosis: Child-Pugh A
Show all 17Show fewer
- Age ≥ 18 years
- ECOG performance status 0-1
- Written informed consent for the translational part of the study
- In addition to the criteria mentioned above, patients should meet the following criteria to be eligible for the treatment with SBRT:
- Measurable disease to be selected as a target on a computed tomography (CT) or magnetic resonance imaging (MRI) scan, according to RECIST 1.1 criteria
- Finished gemcitabine-based chemotherapy treatment, preferably 8 cycles. If less cycles are given, patients are still eligible for this study
- Bilirubin ≤3.0 times normal value, aspartate aminotransferase (AST)/alanine transaminase (ALT) ≤5 times ULN
- Platelets ≥ 50x10E9/ l, Leukocytes > 1.5x10E9/l, Hemoglobin (Hb) > 6 mmol/l
- Willing and able to comply to the follow-up schedule
- Able to start SBRT within 12 weeks after completion of chemotherapy and immuno-therapy (if applicable)
- Written informed consent for the SBRT part of the study
Who cannot join
- Prior surgery or transplantation of the liver
- Tumor extension in stomach, colon, duodenum, pancreas or abdominal wall
- Ascites
- Prior radiotherapy to the liver
- Current pregnancy
- Affected lymph nodes outside the regions described in the inclusion criteria
- Progression (local or distant) during or after chemotherapy
Trial locations and contacts
8 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Suus van Loosbroek, MSc contact
8 sites in 2 countries
Netherlands6 sites, 6 recruiting
- Recruiting
Amsterdam University Medical Center
Amsterdam, North Holland, 1081 HV
Eva Versteijne, MD, PhD, e.versteijne@amsterdamumc.nl
Eva Versteijne, MD, PhD
- Recruiting
University Medical Center Groningen
Groningen, Provincie Groningen, 9713 GZ
Derk Jan de Groot, MD, PhD, d.j.a.de.groot@umcg.nl
Derk Jan de Groot, MD, PhD
- Recruiting
Maastricht University Medical Center+ / Maastro Clinic Maastricht
Maastricht, Limburg, 6229 ET
Jeroen Buijsen, MD, PhD, jeroen.buijsen@maastro.nl
Jeroen Buijsen, MD, PhD
- Recruiting
Radboud University Medical Center
Nijmegen, Gelderland, 6525 GA
Harm Westdorp, MD, PhD, harm.westdorp@radboudumc.nl
Harm Westdorp, MD, PhD
- Recruiting
Erasmus MC
Rotterdam, South Holland, 3015 CD
Alejandra Méndez Romero, MD, PhD, +31 (0)10 7035792, a.mendezromero@erasmusmc.nl
Alejandra Méndez Romero, MD, PhD
- Recruiting
University Medical Center Utrecht
Utrecht, Utrecht, 3584 CX
Prof. Martijn Intven, MD, PhD, m.intven@umcutrecht.nl
Prof. Martijn Intven, MD, PhD
Belgium2 sites, 2 recruiting
- Not yet recruiting
University Hospital Brussels / Jules Bordet Institute
Brussels, Brussels Capital, 1070
Christelle Bouchart, MD, PhD, Christelle.Bouchart@bordet.be
Christelle Bouchart, MD, PhD
- Not yet recruiting
Antwerp University Hospital / Sint-Augustinus Gasthuiszusters
Wilrijk, Antwerp, 2610
Prof. Ines Joye, MD, PhD, ines.joye@gza.be
Prof. Ines Joye, MD, PhD
About this study
Official title: Stereotactic Body Radiation Therapy After Chemotherapy for Unresectable Perihilar Cholangiocarcinoma: A Multicenter Phase II Trial (The STRONG 2 Trial)
The objective of this study is to evaluate the efficacy of stereotactic body radiation therapy (SBRT) as additional treatment after standard chemotherapy regarding tumor local control, toxicity, progression-free survival (PFS), overall survival and quality of life. In addition, the objective is to explore the value of immunodynamics in peripheral blood for predicting PFS in patients undergoing chemotherapy.
Read the detailed description
Rationale:
For patients with perihilar cholangiocarcinoma, surgery is the only treatment modality that can result in cure. Unfortunately, in the majority of these patients the tumors are found to be unresectable at presentation due to local invasive tumor growth or the presence of distal metastases. For patients with unresectable cholangiocarcinoma, palliative chemotherapy is the standard treatment, yielding an estimated median overall survival of 12-15.2 months.
There is no evidence from randomized trials that support the routine use of stereotactic body radiation therapy (SBRT) for cholangiocarcinoma. The STRONG phase I feasibility study showed favorable outcomes regarding safety, and the therapy was generally well tolerated. Based upon these observations, a phase II multi-center study with SBRT after chemotherapy in patients with unresectable perihilar cholangiocarcinoma is proposed, in order to further research the efficacy of adding SBRT to standard chemotherapy.
In addition, an explorative translational research component is part of the study, in which peripheral immunodynamics, specifically myeloid nuclear factor kappa-light-chain enhancer of activated B cells (NF-kB) signaling and interferon-stimulated genes (ISG) responses within the myeloid cells, may help to predict survival after chemotherapy and may also help to predict the value of additional treatment with radiotherapy.
Objective:
The objective of this study is to evaluate the efficacy of SBRT as additional treatment after standard chemotherapy regarding tumor local control, toxicity, progression-free survival (PFS), overall survival and quality of life. In addition, to explore the value of immunodynamics in peripheral blood for predicting PFS in patients undergoing chemotherapy.
Study design:
Single-arm, multicenter phase II study.
Study population:
The initial translational part of the study will be performed in patients diagnosed with unresectable perihilar cholangiocarcinoma, 18 years of age or older, T1-4 N0-2 M0 (AJCC staging 8th edition), eligible for gemcitabine-based chemotherapy. Exclusion criteria are tumor extension into either stomach, colon, duodenum, pancreas or abdominal wall. After completion of chemotherapy and no local or distant progression during or after chemotherapy, the patients will proceed to SBRT if they are still eligible based on the inclusion and exclusion criteria. It may occur that patients do not give consent for the translational part of the study, but they may wish to participate in the SBRT part of the trial and vice versa. Sample size will be 30 patients.
Intervention:
SBRT will be delivered in 15 fractions of 4 to 4.5Gy after 8 cycles of chemotherapy. In case of toxicity causing premature termination of systemic treatment, the patient can still proceed to SBRT.
Main study parameters/endpoints:
The primary endpoint of this study is local tumour control, defined as time from inclusion to local radiological progression. Definition of progression is based on response evaluation criteria in solid tumours (RECIST) 1.1.
Secondary endpoints:
- Toxicity according to the Common Toxicity Criteria for Adverse Events (CTCAE) V.5.0 grading system.
- Biliary stent-related events (SRE).
- Progression-free survival defined as time from inclusion until radiological progression. Definition of progression is based on RECIST 1.1.
- Overall survival defined as time from inclusion until death from any cause.
- Quality of life (QoL), assessed by means of the EuroQol (EQ)-5D-5L (measure of health outcome in general population), and the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 (QoL specific for patients with cancer) with the supplementary module EORTC QLQ-BIL21 (specific for CCA and gallbladder cancer).
- Conditions
- Klatskin Tumor
- Being tested
- Stereotactic body radiation therapy
- Keywords
- Klatskin tumor, Perihilar cholangiocarcinoma, Stereotactic body radiation therapy
- Medical subject headings
- Klatskin Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic body radiation therapyRadiation
SBRT will be delivered in 15 fractions of 4 to 4.5Gy (risk-adapted), one fraction each weekday for 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Stereotactic body radiation therapy | Experimental | Single-arm study Receives: Radiation: Stereotactic body radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local tumor control
Local tumor control is defined as time from inclusion to local radiological progression. Definition of progression is based on response evaluation criteria in solid tumors (RECIST) 1.1. In RECIST 1.1, response of a tumor to treatment is defined as either complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD).
Measured: 42 months (maximum follow-up time)
Secondary outcomes (7)
Progression-free survival (PFS)
PFS is defined as time from inclusion until radiological progression. Definition of progression is based on RECIST 1.1.
Measured: 42 months (maximum follow-up time)
Overall survival (OS)
OS is defined as time from inclusion until death from any cause.
Measured: 42 months (maximum follow-up time)
Adverse events
Adverse events assessed by the Common Toxicity Criteria for Adverse Events (CTCAE) V.5.0
Measured: 42 months (maximum follow-up time)
Biliary stent-related events (SRE)
The definition of SRE in this study is based on the definition used in the study by Lamarca et al. (https://doi.org/10.3748/wjg.v22.i26.6065). A SRE is defined as any one or more of the following: 1. any episode of jaundice which is considered significant enough for new stenting or medical treatment and is confirmed by radiological imaging to be associated with biliary dilatation; 2. any episode of infection which is clinically in keeping with cholangitis (bile duct infection) requiring antibiotic therapy; 3. bacteraemia with isolation in blood cultures of bacteria suspected to have originated in the biliary tract; and 4. any episode of cholecystitis or gallbladder perforation.
Measured: 42 months (maximum follow-up time)
Quality of life (QoL) - EQ-5D-5L
Assessed by means of the EuroQol (EQ)-5D-5L (measure of health outcome in general population).
Measured: 36 months
Quality of life (QoL) - QLQ-C30
Assessed by means of the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 (QoL specific for patients with cancer).
Measured: 36 months
Quality of life (QoL) - QLQ-BIL21
Assessed by means of the supplementary module EORTC QLQ-BIL21 (specific for CCA and gallbladder cancer).
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study start1 Jul 2024
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Mar 2028 (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 Klatskin TumorStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Cancer Society
- Responsible party
- Principal investigator, Alejandra Mendez Romero, Erasmus Medical Center
- Investigators
- Alejandra Méndez Romero, MD, PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06493734
- Sponsor's protocol ID
- NL86210.078.24
- Acronym
- STRONG II
- Status last verified
- Dec 2024
- First submitted
- 1 Jul 2024
- Last updated
- 15 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
van Loosbroek SY, Milder MTW, de Ruysscher D, Vaes RDW, den Toom W, Willemssen F, Eskens F, Homs MYV, Groot Koerkamp B, van Driel LMJW, Seppenwoolde Y, van Werkhoven E, Intven M, Haj Mohammad N, de Bruijne J, Versteijne E, Bruynzeel AM, Brandts F, Erdmann JI, Westdorp H, Braam PM, Tjwa ETTL, Bouchart C, Demols A, Gulyban A, Buijsen J, de Vos-Geelen J, Dewulf M, Joye I, Vandamme T, Vonghia L, de Groot DJ, Dieters M, Ubbels FJF, Hoogwater FJH, Heijmen B, Mendez Romero A PHD. STRONG II trial: stereotactic body radiation therapy following chemotherapy for unresectable perihilar cholangiocarcinoma - a single-arm multicentre phase II study. BMJ Open. 2025 Jul 16;15(7):e097545. doi: 10.1136/bmjopen-2024-097545.
PubMed 40669914
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stereotactic Body Radiation Therapy After Chemotherapy for Unresectable Perihilar Cholangiocarcinoma: A Multicenter Phase II Trial (The STRONG 2 Trial)
- ClinicalTrials.gov ID
- NCT06493734
- Acronym / sponsor ID
- STRONG II / NL86210.078.24
- Conditions
- Klatskin Tumor
- Keywords
- Klatskin tumor, Perihilar cholangiocarcinoma, Stereotactic body radiation therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- Dutch Cancer Society
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 10 Jul 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.
The objective of this study is to evaluate the efficacy of stereotactic body radiation therapy (SBRT) as additional treatment after standard chemotherapy regarding tumor local control, toxicity, progression-free survival (PFS), overall survival and quality of life. In addition, the objective is to explore the value of immunodynamics in peripheral blood for predicting PFS in patients undergoing chemotherapy.
Detailed description
Rationale:
For patients with perihilar cholangiocarcinoma, surgery is the only treatment modality that can result in cure. Unfortunately, in the majority of these patients the tumors are found to be unresectable at presentation due to local invasive tumor growth or the presence of distal metastases. For patients with unresectable cholangiocarcinoma, palliative chemotherapy is the standard treatment, yielding an estimated median overall survival of 12-15.2 months.
There is no evidence from randomized trials that support the routine use of stereotactic body radiation therapy (SBRT) for cholangiocarcinoma. The STRONG phase I feasibility study showed favorable outcomes regarding safety, and the therapy was generally well tolerated. Based upon these observations, a phase II multi-center study with SBRT after chemotherapy in patients with unresectable perihilar cholangiocarcinoma is proposed, in order to further research the efficacy of adding SBRT to standard chemotherapy.
In addition, an explorative translational research component is part of the study, in which peripheral immunodynamics, specifically myeloid nuclear factor kappa-light-chain enhancer of activated B cells (NF-kB) signaling and interferon-stimulated genes (ISG) responses within the myeloid cells, may help to predict survival after chemotherapy and may also help to predict the value of additional treatment with radiotherapy.
Objective:
The objective of this study is to evaluate the efficacy of SBRT as additional treatment after standard chemotherapy regarding tumor local control, toxicity, progression-free survival (PFS), overall survival and quality of life. In addition, to explore the value of immunodynamics in peripheral blood for predicting PFS in patients undergoing chemotherapy.
Study design:
Single-arm, multicenter phase II study.
Study population:
The initial translational part of the study will be performed in patients diagnosed with unresectable perihilar cholangiocarcinoma, 18 years of age or older, T1-4 N0-2 M0 (AJCC staging 8th edition), eligible for gemcitabine-based chemotherapy. Exclusion criteria are tumor extension into either stomach, colon, duodenum, pancreas or abdominal wall. After completion of chemotherapy and no local or distant progression during or after chemotherapy, the patients will proceed to SBRT if they are still eligible based on the inclusion and exclusion criteria. It may occur that patients do not give consent for the translational part of the study, but they may wish to participate in the SBRT part of the trial and vice versa. Sample size will be 30 patients.
Intervention:
SBRT will be delivered in 15 fractions of 4 to 4.5Gy after 8 cycles of chemotherapy. In case of toxicity causing premature termination of systemic treatment, the patient can still proceed to SBRT.
Main study parameters/endpoints:
The primary endpoint of this study is local tumour control, defined as time from inclusion to local radiological progression. Definition of progression is based on response evaluation criteria in solid tumours (RECIST) 1.1.
Secondary endpoints:
- Toxicity according to the Common Toxicity Criteria for Adverse Events (CTCAE) V.5.0 grading system.
- Biliary stent-related events (SRE).
- Progression-free survival defined as time from inclusion until radiological progression. Definition of progression is based on RECIST 1.1.
- Overall survival defined as time from inclusion until death from any cause.
- Quality of life (QoL), assessed by means of the EuroQol (EQ)-5D-5L (measure of health outcome in general population), and the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 (QoL specific for patients with cancer) with the supplementary module EORTC QLQ-BIL21 (specific for CCA and gallbladder cancer).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stereotactic body radiation therapy | Experimental | Radiation: Stereotactic body radiation therapySingle-arm study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- In order to be eligible to participate in the translational part of the study, a subject must be discussed in a liver tumor board, should be eligible for gemcitabine-based chemotherapy (and immunotherapy, if applicable), and should meet all of the following criteria pre-chemotherapy:
- Perihilar cholangiocarcinoma (pCCA) according to the criteria of the Mayo Clinic, Rochester: a positive or strongly suspicious intraluminal brush cytology or biopsy, or a radiographic malignant appearing stricture plus either: CA 19-9>100 U/ml in the absence of acute bacterial cholangitis, or polysomy on fluorescence in situ hybridization (FISH), or a well-defined mass on cross sectional imaging
- One tumor mass
- Unresectable tumor or patient deemed unfit for surgery
- T1-T4 (AJCC staging 8th edition), N0-N2-M0 (AJCC staging 8th edition), radiologically or pathologically suspect. N1 is defined as one to three affected lymph nodes typically involving the hilar, cystic duct, common bile duct, hepatic artery, posterior pancreatoduodenal, and portal vein lymph nodes. N2 is defined as four or more affected lymph nodes from the sites described for N1. Endoscopic ultrasound (EUS) is leading in identifying pathological lymph nodes compared to CT.
Key exclusion criteria (7 listed)
- Prior surgery or transplantation of the liver
- Tumor extension in stomach, colon, duodenum, pancreas or abdominal wall
- Ascites
- Prior radiotherapy to the liver
- Current pregnancy
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 |
|---|---|---|
| Stereotactic body radiation therapySBRT will be delivered in 15 fractions of 4 to 4.5Gy (risk-adapted), one fraction each weekday for 3 weeks. | Radiation | Stereotactic body radiation therapy |
Primary outcome
Local tumor control
Time frame: 42 months (maximum follow-up time)
Local tumor control is defined as time from inclusion to local radiological progression. Definition of progression is based on response evaluation criteria in solid tumors (RECIST) 1.1. In RECIST 1.1, response of a tumor to treatment is defined as either complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD).
7 secondary outcomes
Progression-free survival (PFS)
Time frame: 42 months (maximum follow-up time)
Overall survival (OS)
Time frame: 42 months (maximum follow-up time)
Adverse events
Time frame: 42 months (maximum follow-up time)
Biliary stent-related events (SRE)
Time frame: 42 months (maximum follow-up time)
Quality of life (QoL) - EQ-5D-5L
Time frame: 36 months
Quality of life (QoL) - QLQ-C30
Time frame: 36 months
Quality of life (QoL) - QLQ-BIL21
Time frame: 36 months
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 15 Jul 2025.
- Derived from this study: PubMed 40669914van Loosbroek SY, Milder MTW, de Ruysscher D, Vaes RDW, den Toom W, Willemssen F, Eskens F, Homs MYV, Groot Koerkamp B, van Driel LMJW, Seppenwoolde Y, van Werkhoven E, Intven M, Haj Mohammad N, de Bruijne J, Versteijne E, Bruynzeel AM, Brandts F, Erdmann JI, Westdorp H, Braam PM, Tjwa ETTL, Bouchart C, Demols A, Gulyban A, Buijsen J, de Vos-Geelen J, Dewulf M, Joye I, Vandamme T, Vonghia L, de Groot DJ, Dieters M, Ubbels FJF, Hoogwater FJH, Heijmen B, Mendez Romero A PHD. STRONG II trial: stereotactic body radiation therapy following chemotherapy for unresectable perihilar cholangiocarcinoma - a single-arm multicentre phase II study. BMJ Open. 2025 Jul 16;15(7):e097545. doi: 10.1136/bmjopen-2024-097545.
- 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.
Suus van Loosbroek, MSc contact
Alejandra Méndez Romero, MD, PhD principal investigator
Erasmus Medical Center
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stereotactic body radiation therapy in people with Klatskin Tumor, run by Erasmus Medical Center at 8 sites in 2 countries.
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 17 inclusion and 7 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 15 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Netherlands, Belgium. 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 Alejandra Méndez Romero, MD, PhD (+31 (0)10 7035792, a.mendezromero@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local tumor control (time frame: 42 months (maximum follow-up time)). 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 NCT06493734, 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 15 Jul 2025.