Recurrent Pancreatic Ductal AdenocarcinomaARCADENCT04881487
Additional Treatment for Isolated Local Pancreatic Cancer Recurrence Using Stereotactic Body Radiation Therapy
A study testing Additional stereotactic body radiation therapy in people with Recurrent Pancreatic Ductal Adenocarcinoma, run by UMC Utrecht at 3 sites in Netherlands.
Trial summary
A randomized controlled trial, nested within an existing prospective cohort (Dutch Pancreatic Cancer Project; PACAP) according to the 'trials within cohorts' (TwiCs) design in which the effect of additional local ablative therapy compared to current standard of care alone, on survival after recurrence in patients with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Pancreatic Ductal Adenocarcinoma
- What is being tested?
- Additional stereotactic body radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 3 sitesNetherlands
- Study dates
- 5 Jul 2021to Feb 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
- Participation in the PACAP cohort with written informed consent for being randomized in future studies
- Isolated local recurrence after primary PDAC resection
- Minimum age of 18 years
Who cannot join
- Distant metastases
- Expected lifespan < 3 months
- Ineligibility for MRI or CT according to the protocol of the local radiology department;
- Highly selective cases with resectable, isolated local recurrence without the need for either systemic or local ablative induction therapy, eligible for re-resection according to the expert panel.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands3 sites, 3 recruiting
- Recruiting
Amsterdam University Medical Center, VUmc
Amsterdam, North Holland, 1081 HV
M. P.W. Intven, MD PhD, m.intven@umcutrecht.nl
A. M.E. Bruynzeel, MD, PhD
- Recruiting
Erasmus University Medical Center
Rotterdam, South Holland, 3015 GD
M. P.W. Intven, MD PhD, m.intven@umcutrecht.nl
J. Nuyttens, MD, PhD
- Recruiting
University Medical Center Utrecht
Utrecht, Utrecht, 3584 CX
M. P.W. Intven, MD PhD, m.intven@umcutrecht.nl
M. P.W. Intven, MD, PhD
About this study
Official title: A Randomized Controlled Trial on Additional Treatment for Isolated Local Pancreatic Cancer Recurrence Using Stereotactic Body Radiation Therapy
A randomized controlled trial, nested within an existing prospective cohort (Dutch Pancreatic Cancer Project; PACAP) according to the 'trials within cohorts' (TwiCs) design in which the effect of additional local ablative therapy compared to current standard of care alone, on survival after recurrence in patients with isolated local pancreatic ductal adenocarcinoma (PDAC) recurrence. The most important secondary endpoint is quality of life. Other secondary endpoints are treatment response, acute and late toxicity, overall survival, progression-free survival, local progression-free survival, distant metastases free survival and reasons for non-eligibility or exclusion.
Read the detailed description
Rationale: Disease recurrence remains the main cause of mortality in patients who underwent resection for PDAC. In case of recurrence, patients are currently treated with palliative chemotherapy or best supportive care. In 20-30% of all patients, isolated local PDAC recurrence occurs after resection, which is frequently associated with considerable morbidity from local destructive tumor growth. Although survival after recurrence is predominantly determined by systemic disease, additional local ablative therapy might be of value to improve local disease control in these patients, which could positively affect survival and quality of life (QoL). Previously, radiation therapy has played only a minor role in the treatment of PDAC. As the pancreas is tightly surrounded by organs with limited radiation dose tolerance and subjected to abdominal motion due to respiration and peristalsis, optimal dose delivery has been impeded with conventional radiotherapy techniques. The development of image-guided stereotactic body radiation therapy (SBRT) techniques, however, enabled safe delivery of high irradiation doses to pancreatic lesions. Early retrospective studies have suggested that SBRT might lead to improved local control in patients with isolated local PDAC recurrence, potentially having a beneficial effect on both survival and QoL. In the current, multicenter randomized controlled trial, the value of SBRT in addition to standard of care in patients with isolated local PDAC recurrence is compared to standard of care alone, with regard to both survival and quality of life outcomes.
Objective: The main objective of this study is to improve survival after recurrence in patients with isolated local PDAC recurrence using local ablative treatment with SBRT in addition to standard of care. Furthermore, the effects of additional SBRT on QoL will be evaluated within this study.
Study design: A randomized controlled trial, nested within a prospective cohort (PACAP) according to the TwiCs design.
Study population: PACAP-participants with isolated local PDAC recurrence after primary resection who provided informed consent for being randomized in future studies.
Intervention: Local ablative therapy (5 times 8 Gray SBRT) in addition to standard of care.
Comparison: standard of care.
Main study endpoints: The main study endpoint is survival after recurrence. The most important secondary endpoint is quality of life. Other secondary endpoints are radiological treatment response, acute and late toxicity, overall, progression-free, local progression-free and distant metastasis free survival and reasons for non-eligibility or exclusion.
- Being tested
- Additional stereotactic body radiation therapy
- Keywords
- Stereotactic body radiation therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Additional stereotactic body radiation therapyRadiation
5 fractions of 8 Gray stereotactic body radiation therapy in addition to standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Additional stereotactic body radiation therapy | Experimental | SBRT in addition to standard of care. Receives: Radiation: Additional stereotactic body radiation therapy |
| Standard of care | No intervention | Treatment according to current clinical practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival after recurrence
The interval between the date of PDAC recurrence diagnosis and either death from any cause or last follow-up.
Measured: From the date of PDAC recurrence diagnosis until either death from any cause or last follow-u, whichever came first, assessed up to 24 months
Secondary outcomes (14)
Patient reported Quality of Life as assessed using Exocrine Pancreatic Insufficiency (EPI) questionnaire
Part of the Patient Reported Outcome Measures (PROMs) that are being standardly measured in PACAP-participants.
Measured: At baseline and at 3, 6, 9, 12, 18 and 24 months and every subsequent year after enrollment in the PACAP-cohort. Assessed through study completion, up to 18 months
Patient reported non-disease specific health-related Quality of Life (HRQoL) as assessed using the EQ-5D-5L
Part of the Patient Reported Outcome Measures (PROMs) that are being standardly measured in PACAP-participants.
Measured: At baseline and at 3, 6, 9, 12, 18 and 24 months and every subsequent year after enrollment in the PACAP-cohort. Assessed through study completion, up to 18 months
Patient reported cancer-specific HRQoL as assessed using the EORTC QLQ-C30
Part of the Patient Reported Outcome Measures (PROMs) that are being standardly measured in PACAP-participants.
Measured: At baseline and at 3, 6, 9, 12, 18 and 24 months and every subsequent year after enrollment in the PACAP-cohort. Assessed through study completion, up to 18 months
Patient reported tumor-specific HRQoL as assessed using the EORTC LQPAN26
Part of the Patient Reported Outcome Measures (PROMs) that are being standardly measured in PACAP-participants.
Measured: At baseline and at 3, 6, 9, 12, 18 and 24 months and every subsequent year after enrollment in the PACAP-cohort. Assessed through study completion, up to 18 months
Patient reported chemotherapy-induced peripheral neuropathy as assessed using the EORTC QLQ-CIPN20
Part of the Patient Reported Outcome Measures (PROMs) that are being standardly measured in PACAP-participants.
Measured: At baseline and at 3, 6, 9, 12, 18 and 24 months and every subsequent year after enrollment in the PACAP-cohort. Assessed through study completion, up to 18 months
Patient reported Quality of Life as assessed using the happiness, hospital, anxiety and depression scale (HADS)
Part of the Patient Reported Outcome Measures (PROMs) that are being standardly measured in PACAP-participants.
Measured: At baseline and at 3, 6, 9, 12, 18 and 24 months and every subsequent year after enrollment in the PACAP-cohort. Assessed through study completion, up to 18 months
Patient reported Quality of Life as assessed using the worry of progression of cancer scale (WOPS)
Part of the Patient Reported Outcome Measures (PROMs) that are being standardly measured in PACAP-participants.
Measured: At baseline and at 3, 6, 9, 12, 18 and 24 months and every subsequent year after enrollment in the PACAP-cohort. Assessed through study completion, up to 18 months
Treatment response assessed on CT-imaging (graded according to RECIST guidelines)
Response to SBRT treatment.
Measured: During and immediately after the intervention (SBRT treatment)
Acute and late toxicity of SBRT as assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Assessed during regular follow-up moments. In the intervention arm acute toxicity will be monitored by the treating radiation oncologist. Acute toxicity will be defined as toxicity within 90 days from the end of SBRT treatment and will be assessed in week 1, 3, 6 and 12. Late toxicity is defined as toxicity occurring > 90 days from SBRT.
Measured: Through study completion, an average of 18 months
Overall survival
The interval between the date of primary resection and the date of death from any cause or last follow-up.
Measured: From the date of primary resection until the date of death from any cause or last follow-up, whichever came first, assessed up to 18 months
Progression-free survival
The interval between the date of disease recurrence and the date that local and/or distant progression of disease occurs.
Measured: From the date of disease recurrence until the date that local and/or distant progression of disease occurs, assessed up to 18 months
Local progression-free survival
The interval between the date of disease recurrence and the date that locoregional progression of disease occurs.
Measured: From the date of disease recurrence until the date that locoregional progression of disease occurs, assessed up to 18 months
Distant metastases free survival
The interval between the date of disease recurrence and the date that distant progression of disease occurs.
Measured: From the date of disease recurrence until the date that distant progression of disease occurs, assessed up to 18 months
Reasons for non-eligibility or exclusion for SBRT treatment
e.g. poor condition, patients wish, deteriorated condition, age.
Measured: At the time the patient is assessed eligible for the intervention. Assessed through the study, up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2021
- Study start5 Jul 2021
- Primary completionAug 2026 (estimated)
- Study completionFeb 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 Recurrent Pancreatic Ductal AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Trials within Cohorts (TwiCs)
- Masking
- None (open label)
- Enrolment
- 174 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Pancreatic Cancer Group (DPCG)
- Responsible party
- Principal investigator, Martijn P.W. Intven, MD PhD, UMC Utrecht
- Investigators
- M. P.W. Intven, MD, PhD, Principal investigator, Regional Academic Cancer Center Utrecht (RACU)A. M.E. Bruynzeel, MD, PhD, Principal investigator, Amsterdam University Medical Center, VUmcJ. Nuyttens, MD, PhD, Principal investigator, Erasmus Medical CenterI. Q. Molenaar, MD, PhD, Principal investigator, Regional Academic Cancer Center Utrecht (RACU)M. G.H. Besselink, MD, PhD, Principal investigator, Amsterdam University Medical Center, AMCB. Groot Koerkamp, MD, PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04881487
- Sponsor's protocol ID
- NL74336.041.20
- Other IDs
- 20-805, 12568
- Acronym
- ARCADE
- Status last verified
- Apr 2026
- First submitted
- 25 Mar 2021
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data generated during the ARCADE trial will be made available to other researcher upon request from M.P.W. Intven.
Publications
van Goor IWJM, Daamen LA, Besselink MG, Bruynzeel AME, Busch OR, Cirkel GA, Groot Koerkamp B, Haj Mohammed N, Heerkens HD, van Laarhoven HWM, Meijer GJ, Nuyttens J, van Santvoort HC, van Tienhoven G, Verkooijen HM, Wilmink JW, Molenaar IQ, Intven MPW; Dutch Pancreatic Cancer Group. A nationwide randomized controlled trial on additional treatment for isolated local pancreatic cancer recurrence using stereotactic body radiation therapy (ARCADE). Trials. 2022 Oct 28;23(1):913. doi: 10.1186/s13063-022-06829-1.
PubMed 36307892
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial on Additional Treatment for Isolated Local Pancreatic Cancer Recurrence Using Stereotactic Body Radiation Therapy
- ClinicalTrials.gov ID
- NCT04881487
- Acronym / sponsor ID
- ARCADE / NL74336.041.20
- Keywords
- Stereotactic body radiation therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 174 participants (estimated)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- Dutch Pancreatic Cancer Group (DPCG)
- Study start
- 5 Jul 2021 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 11 May 2021 (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.
A randomized controlled trial, nested within an existing prospective cohort (Dutch Pancreatic Cancer Project; PACAP) according to the 'trials within cohorts' (TwiCs) design in which the effect of additional local ablative therapy compared to current standard of care alone, on survival after recurrence in patients with isolated local pancreatic ductal adenocarcinoma (PDAC) recurrence. The most important secondary endpoint is quality of life. Other secondary endpoints are treatment response, acute and late toxicity, overall survival, progression-free survival, local progression-free survival, distant metastases free survival and reasons for non-eligibility or exclusion.
Detailed description
Rationale: Disease recurrence remains the main cause of mortality in patients who underwent resection for PDAC. In case of recurrence, patients are currently treated with palliative chemotherapy or best supportive care. In 20-30% of all patients, isolated local PDAC recurrence occurs after resection, which is frequently associated with considerable morbidity from local destructive tumor growth. Although survival after recurrence is predominantly determined by systemic disease, additional local ablative therapy might be of value to improve local disease control in these patients, which could positively affect survival and quality of life (QoL). Previously, radiation therapy has played only a minor role in the treatment of PDAC. As the pancreas is tightly surrounded by organs with limited radiation dose tolerance and subjected to abdominal motion due to respiration and peristalsis, optimal dose delivery has been impeded with conventional radiotherapy techniques. The development of image-guided stereotactic body radiation therapy (SBRT) techniques, however, enabled safe delivery of high irradiation doses to pancreatic lesions. Early retrospective studies have suggested that SBRT might lead to improved local control in patients with isolated local PDAC recurrence, potentially having a beneficial effect on both survival and QoL. In the current, multicenter randomized controlled trial, the value of SBRT in addition to standard of care in patients with isolated local PDAC recurrence is compared to standard of care alone, with regard to both survival and quality of life outcomes.
Objective: The main objective of this study is to improve survival after recurrence in patients with isolated local PDAC recurrence using local ablative treatment with SBRT in addition to standard of care. Furthermore, the effects of additional SBRT on QoL will be evaluated within this study.
Study design: A randomized controlled trial, nested within a prospective cohort (PACAP) according to the TwiCs design.
Study population: PACAP-participants with isolated local PDAC recurrence after primary resection who provided informed consent for being randomized in future studies.
Intervention: Local ablative therapy (5 times 8 Gray SBRT) in addition to standard of care.
Comparison: standard of care.
Main study endpoints: The main study endpoint is survival after recurrence. The most important secondary endpoint is quality of life. Other secondary endpoints are radiological treatment response, acute and late toxicity, overall, progression-free, local progression-free and distant metastasis free survival and reasons for non-eligibility or exclusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Trials within Cohorts (TwiCs)
| Arm | Type | Receives |
|---|---|---|
| Additional stereotactic body radiation therapy | Experimental | Radiation: Additional stereotactic body radiation therapySBRT in addition to standard of care. |
| Standard of care | No intervention | –Treatment according to current clinical practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participation in the PACAP cohort with written informed consent for being randomized in future studies
- Isolated local recurrence after primary PDAC resection
- Minimum age of 18 years
Key exclusion criteria (4 listed)
- Distant metastases
- Expected lifespan < 3 months
- Ineligibility for MRI or CT according to the protocol of the local radiology department;
- Highly selective cases with resectable, isolated local recurrence without the need for either systemic or local ablative induction therapy, eligible for re-resection according to the expert panel.
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 |
|---|---|---|
| Additional stereotactic body radiation therapy5 fractions of 8 Gray stereotactic body radiation therapy in addition to standard of care. | Radiation | Additional stereotactic body radiation therapy |
Primary outcome
Survival after recurrence
Time frame: From the date of PDAC recurrence diagnosis until either death from any cause or last follow-u, whichever came first, assessed up to 24 months
The interval between the date of PDAC recurrence diagnosis and either death from any cause or last follow-up.
14 secondary outcomes
Patient reported Quality of Life as assessed using Exocrine Pancreatic Insufficiency (EPI) questionnaire
Time frame: At baseline and at 3, 6, 9, 12, 18 and 24 months and every subsequent year after enrollment in the PACAP-cohort. Assessed through study completion, up to 18 months
Patient reported non-disease specific health-related Quality of Life (HRQoL) as assessed using the EQ-5D-5L
Time frame: At baseline and at 3, 6, 9, 12, 18 and 24 months and every subsequent year after enrollment in the PACAP-cohort. Assessed through study completion, up to 18 months
Patient reported cancer-specific HRQoL as assessed using the EORTC QLQ-C30
Time frame: At baseline and at 3, 6, 9, 12, 18 and 24 months and every subsequent year after enrollment in the PACAP-cohort. Assessed through study completion, up to 18 months
Patient reported tumor-specific HRQoL as assessed using the EORTC LQPAN26
Time frame: At baseline and at 3, 6, 9, 12, 18 and 24 months and every subsequent year after enrollment in the PACAP-cohort. Assessed through study completion, up to 18 months
Patient reported chemotherapy-induced peripheral neuropathy as assessed using the EORTC QLQ-CIPN20
Time frame: At baseline and at 3, 6, 9, 12, 18 and 24 months and every subsequent year after enrollment in the PACAP-cohort. Assessed through study completion, up to 18 months
Patient reported Quality of Life as assessed using the happiness, hospital, anxiety and depression scale (HADS)
Time frame: At baseline and at 3, 6, 9, 12, 18 and 24 months and every subsequent year after enrollment in the PACAP-cohort. Assessed through study completion, up to 18 months
Patient reported Quality of Life as assessed using the worry of progression of cancer scale (WOPS)
Time frame: At baseline and at 3, 6, 9, 12, 18 and 24 months and every subsequent year after enrollment in the PACAP-cohort. Assessed through study completion, up to 18 months
Treatment response assessed on CT-imaging (graded according to RECIST guidelines)
Time frame: During and immediately after the intervention (SBRT treatment)
Acute and late toxicity of SBRT as assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Time frame: Through study completion, an average of 18 months
Overall survival
Time frame: From the date of primary resection until the date of death from any cause or last follow-up, whichever came first, assessed up to 18 months
Progression-free survival
Time frame: From the date of disease recurrence until the date that local and/or distant progression of disease occurs, assessed up to 18 months
Local progression-free survival
Time frame: From the date of disease recurrence until the date that locoregional progression of disease occurs, assessed up to 18 months
Distant metastases free survival
Time frame: From the date of disease recurrence until the date that distant progression of disease occurs, assessed up to 18 months
Reasons for non-eligibility or exclusion for SBRT treatment
Time frame: At the time the patient is assessed eligible for the intervention. Assessed through the study, up to 18 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 5 May 2026.
- Derived from this study: PubMed 36307892van Goor IWJM, Daamen LA, Besselink MG, Bruynzeel AME, Busch OR, Cirkel GA, Groot Koerkamp B, Haj Mohammed N, Heerkens HD, van Laarhoven HWM, Meijer GJ, Nuyttens J, van Santvoort HC, van Tienhoven G, Verkooijen HM, Wilmink JW, Molenaar IQ, Intven MPW; Dutch Pancreatic Cancer Group. A nationwide randomized controlled trial on additional treatment for isolated local pancreatic cancer recurrence using stereotactic body radiation therapy (ARCADE). Trials. 2022 Oct 28;23(1):913. doi: 10.1186/s13063-022-06829-1.
- Individual participant dataSharing planned: Yes. De-identified data generated during the ARCADE trial will be made available to other researcher upon request from M.P.W. Intven.
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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.
M. P.W. Intven, MD, PhD principal investigator
Regional Academic Cancer Center Utrecht (RACU)
A. M.E. Bruynzeel, MD, PhD principal investigator
Amsterdam University Medical Center, VUmc
J. Nuyttens, MD, PhD principal investigator
Erasmus Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Additional stereotactic body radiation therapy in people with Recurrent Pancreatic Ductal Adenocarcinoma, run by UMC Utrecht at 3 sites 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 3 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: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Contact M. P.W. Intven, MD PhD (0630866525, m.intven@umcutrecht.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival after recurrence (time frame: From the date of PDAC recurrence diagnosis until either death from any cause or last follow-u, whichever came first, assessed up to 24 months). 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 NCT04881487, 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 5 May 2026.