Resectable Pancreatic Ductal AdenocarcinomaRADAR-PANCNCT04875325
Recurrent Disease Detection After Resection of Pancreatic Adenocarcinoma Using a Standardized Surveillance Strategy
A study testing Standardized surveillance in people with Resectable Pancreatic Ductal Adenocarcinoma and Recurrent Pancreatic Ductal Adenocarcinoma, run by UMC Utrecht at 11 sites in 2 countries.
Trial summary
A randomized controlled trial, nested within an existing prospective cohort (Dutch Pancreatic Cancer Project; PACAP) and the United Kingdom (UK) Pancreas Cancer: Observations of Practice and survival; PACOPS) according to the 'trials within cohorts' (TwiCs) design in which the effect of a standardized surveillance… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Resectable Pancreatic Ductal Adenocarcinoma, Recurrent Pancreatic Ductal Adenocarcinoma
- What is being tested?
- Standardized surveillance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 306 participants
- Where
- 11 sitesin 2 countries
- Study dates
- 16 Mar 2021to 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participation in the PACAP and PACOPS-cohort with written informed consent for being randomized in future studies
- Histologically confirmed macroscopically radical resected (R0-R1) pancreatic adenocarcinoma
- Minimum age of 18 years
Who cannot join
- Exclusion criteria for contrast-enhanced CT-scan, following the protocol of the department of radiology in each affiliated hospital
- Mentally or physically incapable of consent
- Participation in other studies with a study-specific follow-up
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
Netherlands10 sites
Amsterdam University Medical Center VUmc
Amsterdam, North Holland, 1081 HV
Onze Lieve Vrouwe Gasthuis
Amsterdam, North Holland, 1091 AC
Amsterdam University Medical Center AMC
Amsterdam, North Holland, 1105 AZ
Catharina Ziekenhuis
Eindhoven, North Brabant, 5623 EJ
Medisch Spectrum Twente
Enschede, Overijssel, 7512 KZ
University Medical Center Groningen
Groningen, Provincie Groningen, 9713 GZ
Maastricht UMC
Maastricht, Limburg, 6229 HX
Sint Antonius Ziekenhuis
Nieuwegein, Utrecht, 3435 CM
Radboud University Medical Center
Nijmegen, Gelderland, 6525 GA
University Medical Center Utrecht
Utrecht, Utrecht, 3584 CX
About this study
Official title: Recurrent Disease Detection After Resection of Pancreatic Adenocarcinoma Using a Standardized Surveillance Strategy: a Nationwide Randomized Controlled Trial
A randomized controlled trial, nested within an existing prospective cohort (Dutch Pancreatic Cancer Project; PACAP) and the United Kingdom (UK) Pancreas Cancer: Observations of Practice and survival; PACOPS) according to the 'trials within cohorts' (TwiCs) design in which the effect of a standardized surveillance, with serial tumor marker testing and routine imaging, compared to current non-standardized practice, on overall survival and quality of life in patients with primary resected PDAC is investigated. The most important secondary endpoint is quality of life. Other secondary endpoints are clinical and radiological patterns of PDAC recurrence, the compliance of patients to our standardized follow-up strategy, the impact of a standardized surveillance on (eligibility for) additional treatment, and the tolerance of additional treatment. The need for this clinical trial is emphasized by the the emergence of more potent local and more effective systemic treatments for PDAC recurrence, leading to a rising interest in early diagnosis by a standardized approach to follow-up with routine imaging and serial serum tumor marker testing.
Read the detailed description
Rationale: Radical resection combined with (neo)adjuvant chemotherapy offers the best chances for long-term survival for patients with resectable localized pancreatic ductal adenocarcinoma (PDAC). However, even after radical resection, almost all patients will experience local and/or distant disease recurrence after sufficient follow-up, mostly within 2 years. There is a lack of evidence based effective therapeutic options for the significant group of patients with local recurrence only, in terms of improved survival and/or quality of life. In the case of metastatic disease effective chemotherapy has shown to improve survival, but with a median gain survival of 3-4 months. Taken together, this had led to a hesitant attitude towards postoperative recurrence-focused follow-up. Therefore, in most European countries, including the Netherlands, a standardized approach to follow-up after surgery for PDAC is lacking. Furthermore, current PDAC guidelines regarding follow-up are based on expert opinion and other low-level evidence. However, the emergence of more potent local and more effective systemic treatments for PDAC has led to a rising interest in early diagnosis of PDAC recurrence. To detect PDAC recurrence at an early stage and identify patients with good performance status who are most likely to benefit from additional (experimental) treatment, a standardized approach to follow-up with routine imaging and serial serum tumor marker testing is needed. To determine whether early detection of recurrence can lead to improved survival and quality of life, further studies are warranted.
Objective: The main objective is to evaluate the impact of a standardized surveillance, with serial tumor marker testing and routine imaging, on overall survival and quality of life in patients with primary resected PDAC, compared to current non-standardized practice.
Study design: A randomized controlled trial, nested within an existing prospective cohort (Dutch Pancreatic Cancer Project; PACAP) and the United Kingdom (UK) Pancreas Cancer: Observations of Practice and survival; PACOPS) according to the 'trials within cohorts' (TwiCs) design.
Study population: PACAP or PACOPS-participants with histologically confirmed radical resection (R0-R1) of PDAC, who provided informed consent for being randomized in future studies.
Interventions: Standardized surveillance, existing of clinical evaluation, serum cancer antigen (CA) 19-9 testing, and contrast-enhanced computed tomography (CT-) imaging of chest and abdomen every 3 months during the first 2 years after surgery.
Comparison: Non-standardized clinical follow-up.
Endpoints: The main study endpoint is overall survival. The most important secondary endpoint is quality of life. Other secondary endpoints are clinical and radiological patterns of PDAC recurrence, the compliance of patients to our standardized follow-up strategy, the impact of a standardized surveillance on (eligibility for) additional treatment, and the tolerance of additional treatment.
- Being tested
- Standardized surveillance
- Keywords
- Standardized Surveillance, Follow-up, CA 19-9, Computed Tomography Scan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized surveillanceOther
Standardized 3-monthly surveillance with routine imaging and serum tumor marker testing.
| Study group | Role | What they receive |
|---|---|---|
| Standardized surveillance | Experimental | Standardized surveillance strategy with routine imaging and serum tumor marker testing. Receives: Other: Standardized surveillance |
| Non-standardized surveillance | No intervention | Non-standardized surveillance strategy according to current clinical practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
The interval between the date of PDAC resection and either death from any cause or last follow-up.
Measured: From date of PDAC resection until date of death from any cause or date of last follow-up, whichever came first, assessed up to 24 months
Secondary outcomes (16)
Compliance of the standardized surveillance strategy
The percentage of patients that either accepts or refuses participation in the intervention-arm, i.e. is willing to undergo a standardized follow-up regime.
Measured: Through completion of patient inclusion, an average of 1.5 years
Recurrence-free interval
The interval between the date of PDAC resection and the date of first radiological signs of recurrence, or last follow-up if recurrence is not observed.
Measured: From date of PDAC resection until date of first radiological signs of recurrence, or last follow-up if recurrence is not observed, whichever came first, assessed up to 24 months
Prognostic patient specific characteristics and tumor related factors for disease recurrence
Measured: From date of randomization until disease recurrence or last follow-up, assessed up to 24 months
Role of serum tumor marker testing in detecting recurrent PDAC assessed by the calculated diagnostic accuracy values
Measured: From date of randomization until disease recurrence or last follow-up, assessed up to 24 months
Eligibility for additional (experimental) treatment at the time of recurrence diagnosis based on the ECOG or Karnofsky performance state, or inclusion criteria for study-related treatment of recurrence
Measured: At the time of recurrence diagnosis. Assessed through the study, up to 24 months
Reasons to refrain from treatment for recurrence
e.g. poor condition, patients wish, deteriorated condition, progressive disease, advise treating clinician, death, wait-and-see, age.
Measured: At the time the patient is assessed eligible for additional treatment. Assessed through the study, up to 24 months
Patients' tolerance of additional treatment for PDAC recurrence as assessed by incidence of adverse events (graded according to NCI CTCAE Version 5.0)
Measured: Through study completion, an average of 2 years
Morbidity associated with diagnostic testing assessed by the side-effects of diagnostic testing (i.e. fear of disease recurrence)
Measured: From date of randomization until disease recurrence or last follow-up, whichever came first, assessed up to 24 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 and PACOPS-participants.
Measured: At baseline and at 3, 6, 9, 12, 18 and 24 months and every subsequent year after enrollment in the PACAP and PACOPS-cohort. Assessed through study completion, up to 24 months
Overall costs of a standardized surveillance strategy versus the costs as incurred with the current non-standardized follow-up assessed according to the EQ-5D questionnaire as part of the PACAP and PACOPS-project, and calculated using to a Markov model
Measured: After study completion (estimated duration of 3.5 years)
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 and PACOPS-participants.
Measured: At baseline and at 3, 6, 9, 12, 18 and 24 months and every subsequent year after enrollment in the PACAP and PACOPS-cohort. Assessed through study completion, up to 24 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 and PACOPS-participants.
Measured: At baseline and at 3, 6, 9, 12, 18 and 24 months and every subsequent year after enrollment in the PACAP and PACOPS-cohort. Assessed through study completion, up to 24 months
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 and PACOPS-participants.
Measured: At baseline and at 3, 6, 9, 12, 18 and 24 months and every subsequent year after enrollment in the PACAP and PACOPS-cohort. Assessed through study completion, up to 24 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 and PACOPS-participants.
Measured: At baseline and at 3, 6, 9, 12, 18 and 24 months and every subsequent year after enrollment in the PACAP and PACOPS-cohort. Assessed through study completion, up to 24 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 and PACOPS-participants.
Measured: At baseline and at 3, 6, 9, 12, 18 and 24 months and every subsequent year after enrollment in the PACAP and PACOPS-cohort. Assessed through study completion, up to 24 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 and PACOPS-participants.
Measured: At baseline and at 3, 6, 9, 12, 18 and 24 months and every subsequent year after enrollment in the PACAP and PACOPS-cohort. Assessed through study completion, up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2021
- Study start16 Mar 2021
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (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 Resectable 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Trials within Cohorts (TwiCs)
- Masking
- None (open label)
- Enrolment
- 306 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Pancreatic Cancer Group (DPCG), University of Birmingham
- Responsible party
- Principal investigator, Prof. dr. I.Q. Molenaar, MD, PhD, UMC Utrecht
- Investigators
- I. Q. Molenaar, MD, PhD, Principal investigator, Regional Academic Cancer Center Utrecht (RACU)H. C. van Santvoort, MD, PhD, Principal investigator, Regional Academic Cancer Center Utrecht (RACU)M. G.H. Besselink, MD, PhD, Principal investigator, Academic Medical Center - Cancer Center AmsterdamL. A. Daamen, MD, PhD, Principal investigator, Regional Academic Cancer Center Utrecht (RACU)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04875325
- Sponsor's protocol ID
- NL67115.041.18
- Other IDs
- 20-762
- Acronym
- RADAR-PANC
- Status last verified
- Sep 2024
- First submitted
- 17 Mar 2021
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data generated during the RADAR-PANC trial will be made available to other researcher upon request from I.Q. Molenaar.
Publications
Daamen LA, van Goor IWJM, Groot VP, Andel PCM, Brosens LAA, Busch OR, Cirkel GA, Mohammad NH, Heerkens HD, de Hingh IHJT, Hoogwater F, van Laarhoven HWM, Los M, Meijer GJ, de Meijer VE, Pande R, Roberts KJ, Stoker J, Stommel MWJ, van Tienhoven G, Verdonk RC, Verkooijen HM, Wessels FJ, Wilmink JW, Besselink MG, van Santvoort HC, Intven MPW, Molenaar IQ; Dutch Pancreatic Cancer Group. Recurrent disease detection after resection of pancreatic ductal adenocarcinoma using a recurrence-focused surveillance strategy (RADAR-PANC): protocol of an international randomized controlled trial according to the Trials within Cohorts design. Trials. 2024 Jun 20;25(1):401. doi: 10.1186/s13063-024-08223-5.
PubMed 38902836
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recurrent Disease Detection After Resection of Pancreatic Adenocarcinoma Using a Standardized Surveillance Strategy: a Nationwide Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04875325
- Acronym / sponsor ID
- RADAR-PANC / NL67115.041.18
- Keywords
- Standardized Surveillance, Follow-up, CA 19-9, Computed Tomography Scan
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 306 participants (estimated)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- Dutch Pancreatic Cancer Group (DPCG), University of Birmingham
- Study start
- 16 Mar 2021 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 6 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) and the United Kingdom (UK) Pancreas Cancer: Observations of Practice and survival; PACOPS) according to the 'trials within cohorts' (TwiCs) design in which the effect of a standardized surveillance, with serial tumor marker testing and routine imaging, compared to current non-standardized practice, on overall survival and quality of life in patients with primary resected PDAC is investigated. The most important secondary endpoint is quality of life. Other secondary endpoints are clinical and radiological patterns of PDAC recurrence, the compliance of patients to our standardized follow-up strategy, the impact of a standardized surveillance on (eligibility for) additional treatment, and the tolerance of additional treatment. The need for this clinical trial is emphasized by the the emergence of more potent local and more effective systemic treatments for PDAC recurrence, leading to a rising interest in early diagnosis by a standardized approach to follow-up with routine imaging and serial serum tumor marker testing.
Detailed description
Rationale: Radical resection combined with (neo)adjuvant chemotherapy offers the best chances for long-term survival for patients with resectable localized pancreatic ductal adenocarcinoma (PDAC). However, even after radical resection, almost all patients will experience local and/or distant disease recurrence after sufficient follow-up, mostly within 2 years. There is a lack of evidence based effective therapeutic options for the significant group of patients with local recurrence only, in terms of improved survival and/or quality of life. In the case of metastatic disease effective chemotherapy has shown to improve survival, but with a median gain survival of 3-4 months. Taken together, this had led to a hesitant attitude towards postoperative recurrence-focused follow-up. Therefore, in most European countries, including the Netherlands, a standardized approach to follow-up after surgery for PDAC is lacking. Furthermore, current PDAC guidelines regarding follow-up are based on expert opinion and other low-level evidence. However, the emergence of more potent local and more effective systemic treatments for PDAC has led to a rising interest in early diagnosis of PDAC recurrence. To detect PDAC recurrence at an early stage and identify patients with good performance status who are most likely to benefit from additional (experimental) treatment, a standardized approach to follow-up with routine imaging and serial serum tumor marker testing is needed. To determine whether early detection of recurrence can lead to improved survival and quality of life, further studies are warranted.
Objective: The main objective is to evaluate the impact of a standardized surveillance, with serial tumor marker testing and routine imaging, on overall survival and quality of life in patients with primary resected PDAC, compared to current non-standardized practice.
Study design: A randomized controlled trial, nested within an existing prospective cohort (Dutch Pancreatic Cancer Project; PACAP) and the United Kingdom (UK) Pancreas Cancer: Observations of Practice and survival; PACOPS) according to the 'trials within cohorts' (TwiCs) design.
Study population: PACAP or PACOPS-participants with histologically confirmed radical resection (R0-R1) of PDAC, who provided informed consent for being randomized in future studies.
Interventions: Standardized surveillance, existing of clinical evaluation, serum cancer antigen (CA) 19-9 testing, and contrast-enhanced computed tomography (CT-) imaging of chest and abdomen every 3 months during the first 2 years after surgery.
Comparison: Non-standardized clinical follow-up.
Endpoints: The main study endpoint is overall survival. The most important secondary endpoint is quality of life. Other secondary endpoints are clinical and radiological patterns of PDAC recurrence, the compliance of patients to our standardized follow-up strategy, the impact of a standardized surveillance on (eligibility for) additional treatment, and the tolerance of additional treatment.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Trials within Cohorts (TwiCs)
| Arm | Type | Receives |
|---|---|---|
| Standardized surveillance | Experimental | Other: Standardized surveillanceStandardized surveillance strategy with routine imaging and serum tumor marker testing. |
| Non-standardized surveillance | No intervention | –Non-standardized surveillance strategy 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 and PACOPS-cohort with written informed consent for being randomized in future studies
- Histologically confirmed macroscopically radical resected (R0-R1) pancreatic adenocarcinoma
- Minimum age of 18 years
Key exclusion criteria (3 listed)
- Exclusion criteria for contrast-enhanced CT-scan, following the protocol of the department of radiology in each affiliated hospital
- Mentally or physically incapable of consent
- Participation in other studies with a study-specific follow-up
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 |
|---|---|---|
| Standardized surveillanceStandardized 3-monthly surveillance with routine imaging and serum tumor marker testing. | Other | Standardized surveillance |
Primary outcome
Overall survival
Time frame: From date of PDAC resection until date of death from any cause or date of last follow-up, whichever came first, assessed up to 24 months
The interval between the date of PDAC resection and either death from any cause or last follow-up.
16 secondary outcomes
Compliance of the standardized surveillance strategy
Time frame: Through completion of patient inclusion, an average of 1.5 years
Recurrence-free interval
Time frame: From date of PDAC resection until date of first radiological signs of recurrence, or last follow-up if recurrence is not observed, whichever came first, assessed up to 24 months
Prognostic patient specific characteristics and tumor related factors for disease recurrence
Time frame: From date of randomization until disease recurrence or last follow-up, assessed up to 24 months
Role of serum tumor marker testing in detecting recurrent PDAC assessed by the calculated diagnostic accuracy values
Time frame: From date of randomization until disease recurrence or last follow-up, assessed up to 24 months
Eligibility for additional (experimental) treatment at the time of recurrence diagnosis based on the ECOG or Karnofsky performance state, or inclusion criteria for study-related treatment of recurrence
Time frame: At the time of recurrence diagnosis. Assessed through the study, up to 24 months
Reasons to refrain from treatment for recurrence
Time frame: At the time the patient is assessed eligible for additional treatment. Assessed through the study, up to 24 months
Patients' tolerance of additional treatment for PDAC recurrence as assessed by incidence of adverse events (graded according to NCI CTCAE Version 5.0)
Time frame: Through study completion, an average of 2 years
Morbidity associated with diagnostic testing assessed by the side-effects of diagnostic testing (i.e. fear of disease recurrence)
Time frame: From date of randomization until disease recurrence or last follow-up, whichever came first, assessed up to 24 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 and PACOPS-cohort. Assessed through study completion, up to 24 months
Overall costs of a standardized surveillance strategy versus the costs as incurred with the current non-standardized follow-up assessed according to the EQ-5D questionnaire as part of the PACAP and PACOPS-project, and calculated using to a Markov model
Time frame: After study completion (estimated duration of 3.5 years)
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 and PACOPS-cohort. Assessed through study completion, up to 24 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 and PACOPS-cohort. Assessed through study completion, up to 24 months
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 and PACOPS-cohort. Assessed through study completion, up to 24 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 and PACOPS-cohort. Assessed through study completion, up to 24 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 and PACOPS-cohort. Assessed through study completion, up to 24 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 and PACOPS-cohort. Assessed through study completion, up to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Derived from this study: PubMed 38902836Daamen LA, van Goor IWJM, Groot VP, Andel PCM, Brosens LAA, Busch OR, Cirkel GA, Mohammad NH, Heerkens HD, de Hingh IHJT, Hoogwater F, van Laarhoven HWM, Los M, Meijer GJ, de Meijer VE, Pande R, Roberts KJ, Stoker J, Stommel MWJ, van Tienhoven G, Verdonk RC, Verkooijen HM, Wessels FJ, Wilmink JW, Besselink MG, van Santvoort HC, Intven MPW, Molenaar IQ; Dutch Pancreatic Cancer Group. Recurrent disease detection after resection of pancreatic ductal adenocarcinoma using a recurrence-focused surveillance strategy (RADAR-PANC): protocol of an international randomized controlled trial according to the Trials within Cohorts design. Trials. 2024 Jun 20;25(1):401. doi: 10.1186/s13063-024-08223-5.
- Individual participant dataSharing planned: Yes. De-identified data generated during the RADAR-PANC trial will be made available to other researcher upon request from I.Q. Molenaar.
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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.
I. Q. Molenaar, MD, PhD principal investigator
Regional Academic Cancer Center Utrecht (RACU)
H. C. van Santvoort, MD, PhD principal investigator
Regional Academic Cancer Center Utrecht (RACU)
M. G.H. Besselink, MD, PhD principal investigator
Academic Medical Center - Cancer Center Amsterdam
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standardized surveillance in people with Resectable Pancreatic Ductal Adenocarcinoma and Recurrent Pancreatic Ductal Adenocarcinoma, run by UMC Utrecht at 11 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 3 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Netherlands, United Kingdom. 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?
Results are not available in the source record.
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?
Overall survival (time frame: From date of PDAC resection until date of death from any cause or date of last follow-up, 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 NCT04875325, 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 19 Sep 2024.