Pancreatic CancerPhase 3PREOPANC-3NCT04927780
Perioperative or Adjuvant mFOLFIRINOX for Resectable Pancreatic Cancer
A Phase 3 study testing Leucovorin Calcium, Fluorouracil and Irinotecan Hydrochloride in people with Pancreatic Cancer and Pancreatic Ductal Adenocarcinoma, run by Erasmus Medical Center at 21 sites in 2 countries.
Trial summary
The PREOPANC-3 study is a randomized, multicenter, phase 3 trial. Patients with resectable pancreatic cancer will be randomly assigned (1:1) to 8 cycles of neoadjuvant mFOLFIRINOX followed by surgery and 4 cycles of adjuvant mFOLFIRINOX (arm 1) or to upfront surgery followed by 12 cycles of adjuvant mFOLFIRINOX (arm… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Pancreatic Ductal Adenocarcinoma, Resectable Pancreatic Adenocarcinoma
- What is being tested?
- Leucovorin Calcium, Fluorouracil and Irinotecan Hydrochloride
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 378 participants
- Where
- 21 sitesin 2 countries
- Study dates
- 7 Sep 2021to Jul 2029
- Phase
- Phase 3
- 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
- Histologically or cytologically (Bethesda 5 or 6) confirmed pancreatic ductal adenocarcinoma.
- Resectable tumor according to Dutch Pancreatic Cancer Group criteria: no arterial contact and venous contact with the superior mesenteric vein or portal vein of 90 degrees or less
- No evidence for metastatic disease
- WHO performance status of 0 or 1
- Ability to undergo surgery and mFOLFIRINOX chemotherapy
- Leucocytes (WBC) ≥ 3.0 x 10^9/L
Show all 11Show fewer
- Platelets ≥ 100 x 10^9/L
- Hemoglobin ≥ 6.0 mmol/l
- Renal function: eGFR ≥ 40 ml/min
- Age ≥ 18 years
- Written informed consent
Who cannot join
- Prior radiotherapy, chemotherapy, or surgery for pancreatic cancer.
- Prior chemotherapy precluding mFOLFIRINOX.
- Previous malignancy (excluding non-melanoma skin cancer, pancreatic neuroendocrine tumor (pNET) <2cm, and gastrointestinal stromal tumor (GIST) <2cm), unless no evidence of disease and diagnosed more than 3 years before diagnosis of pancreatic cancer, or with a life expectancy of more than 5 years from date of inclusion.
- Pregnancy or lactation.
- 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
21 sites in 2 countries.
21 sites in 2 countries
Netherlands18 sites
Jeroen Bosch Hospital
's-Hertogenbosch
Meander Medical Center
Amersfoort
Amsterdam UMC
Amsterdam
OLVG
Amsterdam
Amphia Hospital
Breda
Deventer Hospital
Deventer
Catharina Hospital
Eindhoven
Medisch Spectrum Twente
Enschede
University Medical Center Groningen
Groningen
Tjongerschans Hospital
Heerenveen
Medical Center Leeuwarden
Leeuwarden
Leiden University Medical Center
Leiden
Maastricht UMC+
Maastricht
Radboud University Medical Center
Nijmegen
Erasmus MC University Medical Center
Rotterdam
Maasstad Ziekenhuis
Rotterdam
Regional Academic Center Utrecht, Antonius Hospital
Utrecht
Isala Hospital
Zwolle
Sweden3 sites
Sahlgrenska University Hospital
Gothenburg
Skåne University Hospital
Lund
Karolinska University Hospital
Stockholm
About this study
Official title: Perioperative Versus Adjuvant FOLFIRINOX for Resectable Pancreatic Cancer: the PREOPANC-3 Study
The PREOPANC-3 study is a randomized, multicenter, phase 3 trial. Patients with resectable pancreatic cancer will be randomly assigned (1:1) to 8 cycles of neoadjuvant mFOLFIRINOX followed by surgery and 4 cycles of adjuvant mFOLFIRINOX (arm 1) or to upfront surgery followed by 12 cycles of adjuvant mFOLFIRINOX (arm 2).
The primary objective of the trial is to determine whether perioperative mFOLFIRINOX improves overall survival compared with adjuvant mFOLFIRINOX in patients with resectable pancreatic cancer.
- Being tested
- Leucovorin Calcium, Fluorouracil, Irinotecan Hydrochloride, Oxaliplatin, Resection
- Keywords
- Neoadjuvant Therapy, Adjuvant Chemotherapy, Oxaliplatin, Irinotecan, Leucovorin, Fluorouracil, Pancreatic Neoplasms, Pancreatectomy
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV
FluorouracilDrug
IV
IV
OxaliplatinDrug
IV
ResectionProcedure or surgery
Open or minimally-invasive pancreatectomy.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Perioperative mFOLFIRINOX | Experimental | Patients in the intervention arm (arm 1) start with neoadjuvant mFOLFIRINOX (consisting of oxaliplatin 85 mg/m², irinotecan 150 mg/m², leucovorin 400 mg/m², all at day 1, and fluorouracil continuous IV infusion 2.4 g/m² over 46 hours). Cycles are repeated every 14 days. After eight cycles, surgical resection is performed in the absence of unresectable or metastatic disease. After resection, four cycles of adjuvant mFOLFIRINOX are scheduled. Receives: Drug: Leucovorin Calcium; Drug: Fluorouracil; Drug: Irinotecan Hydrochloride; Drug: Oxaliplatin; Procedure: Resection |
| Arm 2: Adjuvant mFOLFIRINOX | Active comparator | Patients in the comparator arm (arm 2) start with surgery. After resection, 12 cycles of adjuvant mFOLFIRINOX (consisting of oxaliplatin 85 mg/m², irinotecan 150 mg/m², leucovorin 400 mg/m², all at day 1, and fluorouracil continuous IV infusion 2.4 g/m² over 46 hours) are scheduled. Receives: Drug: Leucovorin Calcium; Drug: Fluorouracil; Drug: Irinotecan Hydrochloride; Drug: Oxaliplatin; Procedure: Resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
The time between randomization and death from any cause. Patients alive at last follow-up are censored.
Measured: Up to 5 years after randomization.
Secondary outcomes (27)
Progression free survival
The time between randomization and locoregional progressive disease before or during treatment (resulting in irresectability), the occurrence of distant metastases, recurrent pancreatic cancer after surgery or death from any cause. Patients alive and free of these events at last follow-up are censored.
Measured: Up to 5 years after randomization.
Distant metastases free survival
The time between randomization and the occurrence of distant metastases or death from any cause. Patients alive and free of these events at last follow-up are censored.
Measured: Up to 5 years after randomization.
Locoregional progression free survival
The time between randomization and locoregional progression before or during treatment (resulting in irresectability), locoregional recurrence after resection or death from any cause. Patients alive and free of these events at last follow-up are censored.
Measured: Up to 5 years after randomization.
Distant metastases free interval
The time between randomization and the occurrence of distant metastases. Distant metastases are considered an event and patients are censored at death or last follow-up when without this event.
Measured: Up to 5 years after randomization.
Locoregional progression free interval
The time between randomization and locoregional progression before or during treatment (resulting in irresectability), or locoregional recurrence after resection. Locoregional progressive disease before or during treatment or locoregional recurrence after resection are considered an event and patients are censored at death or last follow-up when free of these events.
Measured: Up to 5 years after randomization.
Chemotherapy start rate
The percentage of patients who received at least one cycle of scheduled chemotherapy.
Measured: 4 months
Number of chemotherapy cycles received.
The number of mFOLFIRINOX cycles patients received.
Measured: 9 months
Chemotherapy completion rate
The percentage of patients who completed all cycles of scheduled chemotherapy.
Measured: 9 months
Dose intensity
The amount of drug delivered as a percentage of planned dose according to the protocol.
Measured: 9 months
Staging laparoscopy rate
The percentage of patients that actually underwent a staging laparoscopy, regardless whether a surgical exploration or resection was performed.
Measured: At the time of surgery.
Laparoscopy yield
The percentage of patients that underwent staging laparoscopy and were diagnosed with metastatic or unresectable disease during this procedure.
Measured: At the time of surgery.
Surgical exploration rate
The percentage of patients who underwent a surgical exploration (open or minimally-invasive), regardless whether a resection was performed.
Measured: At the time of surgery.
Resection rate
The percentage of patients that underwent a curative-intent resection.
Measured: At the time of surgery.
Microscopically margin-negative (R0) resection rate
The percentage of patients that underwent a microscopically margin-negative (R0) resection. The resection is considered R0 if there is no tumor within 1 mm of the margins.
Measured: At the time of surgery.
Lymph node-negative (N0) resection rate
The percentage of patients that underwent a resection with negative lymph nodes (N0) in the surgical specimen.
Measured: At the time of surgery.
Pathologic response
Tumor regression score in the surgical specimen
Measured: At the time of surgery.
Adverse events as assessed by the CTCAE version 5.0
Adverse events are assessed during neoadjuvant therapy and adjuvant therapy.
Measured: Until 30 days after last chemotherapy.
Postoperative complications
According to the Clavien-Dindo classification and by the International Study Group of Pancreatic Surgery and International Study Group of Liver Surgery.
Measured: Up to 90 days after surgery.
Serum CA 19-9 and CEA response
The change in carbohydrate antigen 19-9 (CA 19-9) and carcinoembryonic antigen (CEA) after surgery and after 4, 8, and 12 cycles of mFOLFIRINOX compared to baseline.
Measured: 9 months
Clinical response rate according to RECIST criteria version 1.1
Response comparing baseline and restaging after 4 and 8 cycles of mFOLFIRINOX
Measured: At the time of surgery.
Patient reported cancer-specific health-related Quality of Life (HRQoL) as assessed using the EORTC QLQ-C30
At baseline and at 3, 6, 9, 12, 18 and 24 months and every subsequent year
Measured: Up to 5 years after randomization.
Patient reported non-disease specific HRQoL as assessed using the EQ-5D-5L
At baseline and at 3, 6, 9, 12, 18 and 24 months and every subsequent year
Measured: Up to 5 years after randomization.
Patient reported tumor-specific HRQoL as assessed using the EORTC LQPAN26
At baseline and at 3, 6, 9, 12, 18 and 24 months and every subsequent year
Measured: Up to 5 years after randomization.
Patient reported Quality of Life as assessed using the worry of progression of cancer scale (WOPS)
At baseline and at 3, 6, 9, 12, 18 and 24 months and every subsequent year
Measured: Up to 5 years after randomization.
Patient reported chemotherapy-induced peripheral neuropathy as assessed using the EORTC QLQ-CIPN20
At baseline and at 3, 6, 9, 12, 18 and 24 months and every subsequent year
Measured: Up to 5 years after randomization.
Patient reported Quality of Life as assessed using the happiness, hospital, anxiety and depression scale (HADS)
At baseline and at 3, 6, 9, 12, 18 and 24 months and every subsequent year
Measured: Up to 5 years after randomization.
Patient reported Quality of Life as assessed using Exocrine Pancreatic Insufficiency (EPI) questionnaire
At baseline and at 3, 6, 9, 12, 18 and 24 months and every subsequent year
Measured: Up to 5 years after randomization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2021
- Study start7 Sep 2021
- Primary completionJan 2027 (estimated)
- Study completionJul 2029 (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 Pancreatic CancerStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 378 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Pancreatic Cancer Group, Dutch Cancer Society
- Responsible party
- Principal investigator, Bas Groot Koerkamp, MD, PhD, Erasmus Medical Center
- Investigators
- Bas Groot Koerkamp, MD, PhD, Principal investigator, Erasmus MC University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04927780
- Sponsor's protocol ID
- MEC-2021-0002
- Other IDs
- 2020-005141-16
- Acronym
- PREOPANC-3
- Status last verified
- May 2026
- First submitted
- 8 Jun 2021
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
van Dam JL, Verkolf EMM, Dekker EN, Bonsing BA, Bratlie SO, Brosens LAA, Busch OR, van Driel LMJW, van Eijck CHJ, Feshtali S, Ghorbani P, de Groot DJA, de Groot JWB, Haberkorn BCM, de Hingh IH, van der Holt B, Karsten TM, van der Kolk MB, Labori KJ, Liem MSL, Loosveld OJL, Molenaar IQ, Polee MB, van Santvoort HC, de Vos-Geelen J, Wumkes ML, van Tienhoven G, Homs MYV, Besselink MG, Wilmink JW, Groot Koerkamp B; Dutch Pancreatic Cancer Group. Perioperative or adjuvant mFOLFIRINOX for resectable pancreatic cancer (PREOPANC-3): study protocol for a multicenter randomized controlled trial. BMC Cancer. 2023 Aug 7;23(1):728. doi: 10.1186/s12885-023-11141-5.
PubMed 37550634
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Versus Adjuvant FOLFIRINOX for Resectable Pancreatic Cancer: the PREOPANC-3 Study
- ClinicalTrials.gov ID
- NCT04927780
- Acronym / sponsor ID
- PREOPANC-3 / MEC-2021-0002
- Keywords
- Neoadjuvant Therapy, Adjuvant Chemotherapy, Oxaliplatin, Irinotecan, Leucovorin, Fluorouracil, Pancreatic Neoplasms, Pancreatectomy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 378 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- Dutch Pancreatic Cancer Group, Dutch Cancer Society
- Study start
- 7 Sep 2021 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 16 Jun 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.
The PREOPANC-3 study is a randomized, multicenter, phase 3 trial. Patients with resectable pancreatic cancer will be randomly assigned (1:1) to 8 cycles of neoadjuvant mFOLFIRINOX followed by surgery and 4 cycles of adjuvant mFOLFIRINOX (arm 1) or to upfront surgery followed by 12 cycles of adjuvant mFOLFIRINOX (arm 2).
The primary objective of the trial is to determine whether perioperative mFOLFIRINOX improves overall survival compared with adjuvant mFOLFIRINOX in patients with resectable pancreatic cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Perioperative mFOLFIRINOX | Experimental | Drug: Leucovorin Calcium, Drug: Fluorouracil, Drug: Irinotecan Hydrochloride, Drug: Oxaliplatin, Procedure: ResectionPatients in the intervention arm (arm 1) start with neoadjuvant mFOLFIRINOX (consisting of oxaliplatin 85 mg/m², irinotecan 150 mg/m², leucovorin 400 mg/m², all at day 1, and fluorouracil continuous IV infusion 2.4 g/m² over 46 hours). Cycles are repeated every 14 days. After eight cycles, surgical resection is performed in the absence of unresectable or metastatic disease. After resection, four cycles of adjuvant mFOLFIRINOX are scheduled. |
| Arm 2: Adjuvant mFOLFIRINOX | Active comparator | Drug: Leucovorin Calcium, Drug: Fluorouracil, Drug: Irinotecan Hydrochloride, Drug: Oxaliplatin, Procedure: ResectionPatients in the comparator arm (arm 2) start with surgery. After resection, 12 cycles of adjuvant mFOLFIRINOX (consisting of oxaliplatin 85 mg/m², irinotecan 150 mg/m², leucovorin 400 mg/m², all at day 1, and fluorouracil continuous IV infusion 2.4 g/m² over 46 hours) are scheduled. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Histologically or cytologically (Bethesda 5 or 6) confirmed pancreatic ductal adenocarcinoma.
- Resectable tumor according to Dutch Pancreatic Cancer Group criteria: no arterial contact and venous contact with the superior mesenteric vein or portal vein of 90 degrees or less
- No evidence for metastatic disease
- WHO performance status of 0 or 1
- Ability to undergo surgery and mFOLFIRINOX chemotherapy
Key exclusion criteria (5 listed)
- Prior radiotherapy, chemotherapy, or surgery for pancreatic cancer.
- Prior chemotherapy precluding mFOLFIRINOX.
- Previous malignancy (excluding non-melanoma skin cancer, pancreatic neuroendocrine tumor (pNET) <2cm, and gastrointestinal stromal tumor (GIST) <2cm), unless no evidence of disease and diagnosed more than 3 years before diagnosis of pancreatic cancer, or with a life expectancy of more than 5 years from date of inclusion.
- Pregnancy or lactation.
- 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 |
|---|---|---|
| Leucovorin CalciumIV | Drug | Arm 1: Perioperative mFOLFIRINOX, Arm 2: Adjuvant mFOLFIRINOX |
| FluorouracilIV | Drug | Arm 1: Perioperative mFOLFIRINOX, Arm 2: Adjuvant mFOLFIRINOX |
| Irinotecan HydrochlorideIV | Drug | Arm 1: Perioperative mFOLFIRINOX, Arm 2: Adjuvant mFOLFIRINOX |
| OxaliplatinIV | Drug | Arm 1: Perioperative mFOLFIRINOX, Arm 2: Adjuvant mFOLFIRINOX |
| ResectionOpen or minimally-invasive pancreatectomy. | Procedure or surgery | Arm 1: Perioperative mFOLFIRINOX, Arm 2: Adjuvant mFOLFIRINOX |
Primary outcome
Overall survival
Time frame: Up to 5 years after randomization.
The time between randomization and death from any cause. Patients alive at last follow-up are censored.
27 secondary outcomes
Progression free survival
Time frame: Up to 5 years after randomization.
Distant metastases free survival
Time frame: Up to 5 years after randomization.
Locoregional progression free survival
Time frame: Up to 5 years after randomization.
Distant metastases free interval
Time frame: Up to 5 years after randomization.
Locoregional progression free interval
Time frame: Up to 5 years after randomization.
Chemotherapy start rate
Time frame: 4 months
Number of chemotherapy cycles received.
Time frame: 9 months
Chemotherapy completion rate
Time frame: 9 months
Dose intensity
Time frame: 9 months
Staging laparoscopy rate
Time frame: At the time of surgery.
Laparoscopy yield
Time frame: At the time of surgery.
Surgical exploration rate
Time frame: At the time of surgery.
Resection rate
Time frame: At the time of surgery.
Microscopically margin-negative (R0) resection rate
Time frame: At the time of surgery.
Lymph node-negative (N0) resection rate
Time frame: At the time of surgery.
Pathologic response
Time frame: At the time of surgery.
Adverse events as assessed by the CTCAE version 5.0
Time frame: Until 30 days after last chemotherapy.
Postoperative complications
Time frame: Up to 90 days after surgery.
Serum CA 19-9 and CEA response
Time frame: 9 months
Clinical response rate according to RECIST criteria version 1.1
Time frame: At the time of surgery.
Patient reported cancer-specific health-related Quality of Life (HRQoL) as assessed using the EORTC QLQ-C30
Time frame: Up to 5 years after randomization.
Patient reported non-disease specific HRQoL as assessed using the EQ-5D-5L
Time frame: Up to 5 years after randomization.
Patient reported tumor-specific HRQoL as assessed using the EORTC LQPAN26
Time frame: Up to 5 years after randomization.
Patient reported Quality of Life as assessed using the worry of progression of cancer scale (WOPS)
Time frame: Up to 5 years after randomization.
Patient reported chemotherapy-induced peripheral neuropathy as assessed using the EORTC QLQ-CIPN20
Time frame: Up to 5 years after randomization.
Patient reported Quality of Life as assessed using the happiness, hospital, anxiety and depression scale (HADS)
Time frame: Up to 5 years after randomization.
Patient reported Quality of Life as assessed using Exocrine Pancreatic Insufficiency (EPI) questionnaire
Time frame: Up to 5 years after randomization.
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 May 2026.
- Background: PubMed 37550634van Dam JL, Verkolf EMM, Dekker EN, Bonsing BA, Bratlie SO, Brosens LAA, Busch OR, van Driel LMJW, van Eijck CHJ, Feshtali S, Ghorbani P, de Groot DJA, de Groot JWB, Haberkorn BCM, de Hingh IH, van der Holt B, Karsten TM, van der Kolk MB, Labori KJ, Liem MSL, Loosveld OJL, Molenaar IQ, Polee MB, van Santvoort HC, de Vos-Geelen J, Wumkes ML, van Tienhoven G, Homs MYV, Besselink MG, Wilmink JW, Groot Koerkamp B; Dutch Pancreatic Cancer Group. Perioperative or adjuvant mFOLFIRINOX for resectable pancreatic cancer (PREOPANC-3): study protocol for a multicenter randomized controlled trial. BMC Cancer. 2023 Aug 7;23(1):728. doi: 10.1186/s12885-023-11141-5.
- Individual participant dataSharing planned: Yes
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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.
Bas Groot Koerkamp, MD, PhD principal investigator
Erasmus MC University Medical Center
21 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Leucovorin Calcium, Fluorouracil and Irinotecan Hydrochloride in people with Pancreatic Cancer and Pancreatic Ductal Adenocarcinoma, run by Erasmus Medical Center at 21 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 11 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 15 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 21 sites in Netherlands, Sweden. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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: Up to 5 years after randomization.). 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 NCT04927780, 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 May 2026.