Locally Advanced Pancreatic AdenocarcinomaLAPSTARNCT06272162
Locally Advanced Pancreatic Cancer After Systemic Therapy: Ablative MR-guided Radiotherapy
A study testing MR guided radiotherapy in people with Locally Advanced Pancreatic Adenocarcinoma, run by UMC Utrecht at 4 sites in Netherlands.
Trial summary
A randomized controlled trial comparing the effect of local ablative MR-guided radiotherapy (MRgRT) after systemic therapy with current standard treatment alone, on health-related quality of life in patients with locally advanced pancreatic cancer (LAPC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Pancreatic Adenocarcinoma
- What is being tested?
- MR guided radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 4 sitesNetherlands
- Study dates
- Feb 2024to Jan 2030
- 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
- Pathology proven pancreatic ductal adenocarcinoma (PDAC);
- At least two (preferably four) months systemic therapy with (m)FOLFIRINOX and/or gemcitabine + nab-paclitaxel; or eligibility for chemotherapy but no initiation of chemotherapy based on patients' wish;
- No option for surgical resection, either because anatomical irresectability based on the surgeon's judgement (assessed on imaging or during explorative laparotomy) and/or frailty (unfit for surgery or chemotherapy) and/or no surgery based on patient's wish.
- No evidence of distant metastatic disease progression, evaluated by CT Thorax / Abdomen / Pelvis and/or PET-CT scan;
- Performance status WHO 0-2.
Who cannot join
- Contra-indications for MRI or CT with an intravenous contrast agent according to the protocol of the local radiology and/or radiotherapy departments
- Contraindications for MRgRT, as determined by the involved expert radiation oncologists of the Consortium
- <18 years old
- Pregnancy
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands4 sites
Amsterdam University Medical Center, VUmc
Amsterdam, North Holland, 1081 HV
J. C.M. Scheepens, MD, j.c.m.scheepens-7@umcutrecht.nl
A. M.E. Bruynzeel, MD, PhD
Catharina Hospital
Eindhoven, North Brabant, 5623 EJ
J. C.M. Scheepens, MD, j.c.m.scheepens-7@umcutrecht.nl
H. M.U. Peulen, MD, PhD
Radboud University Medical Center
Nijmegen, 6525 GA
J. C.M. Scheepens, MD, j.c.m.scheepens-7@umcutrecht.nl
H. D. Heerkens, MD, PhD
University Medical Center Utrecht
Utrecht, 3584CX
J. C.M. Scheepens, MD, j.c.m.scheepens-7@umcutrecht.nl
L. A. Daamen, MD, PhD
About this study
Official title: Locally Advanced Pancreatic Cancer After Systemic Therapy: Ablative MR-guided Radiotherapy, a Randomized Controlled Trial
A randomized controlled trial comparing the effect of local ablative MR-guided radiotherapy (MRgRT) after systemic therapy with current standard treatment alone, on health-related quality of life in patients with locally advanced pancreatic cancer (LAPC).
Read the detailed description
Rationale: About 40% of patients with pancreatic cancer are diagnosed with locally advanced pancreatic cancer (LAPC). Recommended treatment consists of chemotherapy to prevent disease dissemination and prolong survival. Nevertheless, local tumor growth often causes severe morbidity, including pain, gastrointestinal obstruction, and malnutrition. This has a substantial negative impact on health-related quality of life (HRQoL). Eventually, one-third of patients die due to local tumor growth rather than from systemic disease spread. For palliation of symptoms and improved local tumor control, potentially prolonging survival, minimally-invasive ablative therapies may be effective. Online adaptive stereotactic Magnetic Resonance-guided radiotherapy (MRgRT) is an innovative treatment modality that enables high-precision ablative radiotherapy for pancreatic tumors. This potentially improves RT efficacy without increasing the risk of RT-related toxicity. Consequently, MRgRT holds promise for the treatment of pancreatic cancer.
Objective: To investigate the efficacy of stereotactic MRgRT on HRQoL deterioration-free survival, including death as an event, in patients with LAPC after systemic chemotherapy.
Study design: Nationwide randomized controlled trial (1:1 randomization).
Study population: Patients with LAPC according to Dutch Pancreatic Cancer Group (DPCG) criteria who are not eligible for tumor resection after at least two months of chemotherapy (sample size 150 patients). Also, patients with LAPC who are eligible but choose to refrain from chemotherapy and/or surgery can participate in this trial.
Intervention: Patients in the intervention arm receive 50Gy MRgRT in five fractions over two weeks in one of the four Consortium Centers, followed by standard care, either consisting of continuation of chemotherapy or best supportive care. Patients in the control arm continue standard care without ablative MRgRT.
Main study endpoints: The primary outcome is HRQoL deterioration-free survival from the time of randomization, defined as the Time Until Definitive Deterioration (TUDD) including death as an event. HRQoL is evaluated using the EORTC QLQ-C30 Summary Score. The TUDD is defined as a 10-point minimal clinically important difference compared to baseline, with no further improvement of ≥10 points afterwards. All patients will be offered home monitoring using the Trial@home platform to decrease the burden of trial participation.
- Being tested
- MR guided radiotherapy
- Keywords
- MR guided radiation therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR guided radiotherapyRadiation
5 fractions of 10 Gray MRgRT in addition to standard of care
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | Patients in the intervention arm will receive locally ablative stereotactic MRgRT in addition to standard of care, consisting of 5 times 10 Gy MR guided radiotherapy. Receives: Radiation: MR guided radiotherapy |
| Control arm | No intervention | Patients randomized to the control arm will continue standard of care as described without additional local treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
HRQoL deterioration-free survival
HRQoL deterioration-free survival is defined as the Time Until Definitive Deterioration (TUDD) including death from any cause, calculated from the time of randomization. HRQoL is primarily assessed using the EORTC QLQ-C30 (version 3.0) Summary Score.
Measured: Through study completion, an average of 18 months
Secondary outcomes (15)
Overall survival
The time interval between LAPC diagnosis and either death from any cause or last follow-up
Measured: From the date of LAPC diagnosis untill either death from any cause or last follow-up, whichever came first, assessed up to 18 months
Patient reported Quality of Life EORTC QLQ-PAN26
Part of the Patient Reported Outcome Measures (PROMs) using EORTC QLQ-PAN26
Measured: At baseline and at 2,4, weeks and subsequently every 2 months. Assessed through study completion, up to 18 months
Patient reported Quality of Life EORTC QLQ-C30
Part of the Patient Reported Outcome Measures (PROMs) using EORTC QLQ-C30
Measured: At baseline and at 2,4, weeks and subsequently every 2 months. Assessed through study completion, up to 18 months
Patient reported Quality of Life EQ5D-5L
Part of the Patient Reported Outcome Measures (PROMs) using EQ5D-5L
Measured: At baseline and at 2,4, weeks and subsequently every 2 months. Assessed through study completion, up to 18 months
The need of subsequent treatments
To assess continuation of systemic therapy and/or administration of subsequent treatments (e.g., surgery, second-line systemic treatment, experimental treatment in clinical studies etc.), recommendations from multidisciplinary team meetings, reasons for refraining from recommended therapy, and reasons for discontinuation of therapy (i.e., start of best supportive care)
Measured: Through study completion, an average of 18 months
Treatment response assessed on CT-imaging (graded according to RECIST guidelines)
To assess tumor response on imaging according to RECIST criteria in patients who received imaging procedures during follow-up (no part of the trial follow-up)
Measured: with available imaging during 18 months follow-up
CA 19.9 response
To assess serum CA 19-9 response in patients in whom serum CA 19-9 is measured (no part of the trial follow-up)
Measured: Through study completion, an average of 18 months
Trial@home monitoring related outcome: feasibility Withings Steel HR smartwatch
To assess the feasibility of the Trial@home monitoring via the Withings Steel HR smartwatch for home monitoring of pancreatic cancer patients.
Compliance Withings Steel HR smartwatch (wear-time): amount of time (hours) in a day that the participant wears the smartwatch. This is calculated by the amount of time the device registers a heart rate. Patients wearing the device for >50% of the observation period will be considered as feasible.
Measured: Through study completion, an average of 18 months
Trial@home monitoring related outcome: feasibility Body+ scale
To assess the feasibility of the Trial@home monitoring via the Body+ scale for home monitoring of pancreatic cancer patients.
Compliance rates Body+ scale: compliance with weekly weight measurements is calculated by the number of completed weight measurements divided by the total amount of weeks in the observation period. A compliance rate of at least 75% will be considered as feasible.
Measured: Through study completion, an average of 18 months
Trial@home monitoring related outcome: feasibility Whitings Sleep
To assess the feasibility of the Trial@home monitoring via the Whitings Sleep for home monitoring of pancreatic cancer patients.
Compliance Whitings Sleep: compliance with daily sleep monitoring is calculated by the number of nights sleep is measured. A compliance rate of at least 75% nights per week will be considered as feasible.
Measured: Through study completion, an average of 18 months
Trial@home monitoring related outcome: feasibility ePRO application
To assess the feasibility of the Trial@home monitoring via the ePRO application for home monitoring of pancreatic cancer patients.
Compliance questionnaires through the ePROapplication: A compliance rate of at least 75% from the scheduled assessments will be considered as feasible.
Measured: Through study completion, an average of 18 months
Trial@home monitoring related outcome: digital biomarkers
To exploratively generate digital biomarkers and quantify the correlation between data obtained from the Trial@home platform (Withings Steel HR smartwatch, a Withings Body+ Scale, a Withings Sleep, ePRO) and clinical endpoints (e.g., unplanned hospitalizations, early signs of adverse events, clinical deterioration, performance status, quality of life)
Measured: Through study completion, an average of 18 months
Intervention arm related outcome toxicity
To assess acute (3 months) RT-related toxicity measured from the start of MRgRT, according to CTCAE v527
Measured: Through study completion, an average of 18 months
Intervention arm related outcome, completion of therapy
To assess completion of therapy
Measured: Through study completion, an average of 18 months
Intervention arm related outcome diffusion weighted images
To assess correlation of diffusion weighted images at each treatment fraction and the possible correlation with outcomes for patients treated on a 1.5T MR-Linac
Measured: Through study completion, an average of 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2024
- Study startFeb 2024 (estimated)
- Primary completionJan 2030 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Pancreatic AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- RCT
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- Amsterdam UMC, location VUmc, Radboud University Medical Center, Catharina Ziekenhuis Eindhoven, Centre for Human Drug Research, Netherlands, Dutch Pancreatic Cancer Group (DPCG)
- Responsible party
- Principal investigator, Lois Daamen, UMC Utrecht
- Investigators
- L. A. Daamen, MD, PhD, Principal investigator, Regional Academic Cancer Center Utrecht (RACU)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, VUmcH. D. Heerkens, MD, PhD, Principal investigator, Radboud University Medical CenterH. M.U. Peulen, MD, PhD, Principal investigator, Catharina Ziekenhuis EindhovenJ. J. Bosch, Principal investigator, Centre of Human Drug Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06272162
- Sponsor's protocol ID
- NL85622.041.24
- Other IDs
- 15030, 23U-0725
- Acronym
- LAPSTAR
- Status last verified
- Feb 2024
- First submitted
- 8 Jan 2024
- Last updated
- 22 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-dentified data generated during the LAPSTAR trial will be made available to other researchers upon request from L.A. Daamen
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Locally Advanced Pancreatic Cancer After Systemic Therapy: Ablative MR-guided Radiotherapy, a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06272162
- Acronym / sponsor ID
- LAPSTAR / NL85622.041.24
- Keywords
- MR guided radiation therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- Amsterdam UMC, location VUmc, Radboud University Medical Center, Catharina Ziekenhuis Eindhoven, Centre for Human Drug Research, Netherlands, Dutch Pancreatic Cancer Group (DPCG)
- Study start
- Feb 2024 (estimated)
- Primary completion
- Jan 2030 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 22 Feb 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.
A randomized controlled trial comparing the effect of local ablative MR-guided radiotherapy (MRgRT) after systemic therapy with current standard treatment alone, on health-related quality of life in patients with locally advanced pancreatic cancer (LAPC).
Detailed description
Rationale: About 40% of patients with pancreatic cancer are diagnosed with locally advanced pancreatic cancer (LAPC). Recommended treatment consists of chemotherapy to prevent disease dissemination and prolong survival. Nevertheless, local tumor growth often causes severe morbidity, including pain, gastrointestinal obstruction, and malnutrition. This has a substantial negative impact on health-related quality of life (HRQoL). Eventually, one-third of patients die due to local tumor growth rather than from systemic disease spread. For palliation of symptoms and improved local tumor control, potentially prolonging survival, minimally-invasive ablative therapies may be effective. Online adaptive stereotactic Magnetic Resonance-guided radiotherapy (MRgRT) is an innovative treatment modality that enables high-precision ablative radiotherapy for pancreatic tumors. This potentially improves RT efficacy without increasing the risk of RT-related toxicity. Consequently, MRgRT holds promise for the treatment of pancreatic cancer.
Objective: To investigate the efficacy of stereotactic MRgRT on HRQoL deterioration-free survival, including death as an event, in patients with LAPC after systemic chemotherapy.
Study design: Nationwide randomized controlled trial (1:1 randomization).
Study population: Patients with LAPC according to Dutch Pancreatic Cancer Group (DPCG) criteria who are not eligible for tumor resection after at least two months of chemotherapy (sample size 150 patients). Also, patients with LAPC who are eligible but choose to refrain from chemotherapy and/or surgery can participate in this trial.
Intervention: Patients in the intervention arm receive 50Gy MRgRT in five fractions over two weeks in one of the four Consortium Centers, followed by standard care, either consisting of continuation of chemotherapy or best supportive care. Patients in the control arm continue standard care without ablative MRgRT.
Main study endpoints: The primary outcome is HRQoL deterioration-free survival from the time of randomization, defined as the Time Until Definitive Deterioration (TUDD) including death as an event. HRQoL is evaluated using the EORTC QLQ-C30 Summary Score. The TUDD is defined as a 10-point minimal clinically important difference compared to baseline, with no further improvement of ≥10 points afterwards. All patients will be offered home monitoring using the Trial@home platform to decrease the burden of trial participation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- RCT
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Radiation: MR guided radiotherapyPatients in the intervention arm will receive locally ablative stereotactic MRgRT in addition to standard of care, consisting of 5 times 10 Gy MR guided radiotherapy. |
| Control arm | No intervention | –Patients randomized to the control arm will continue standard of care as described without additional local treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Pathology proven pancreatic ductal adenocarcinoma (PDAC);
- At least two (preferably four) months systemic therapy with (m)FOLFIRINOX and/or gemcitabine + nab-paclitaxel; or eligibility for chemotherapy but no initiation of chemotherapy based on patients' wish;
- No option for surgical resection, either because anatomical irresectability based on the surgeon's judgement (assessed on imaging or during explorative laparotomy) and/or frailty (unfit for surgery or chemotherapy) and/or no surgery based on patient's wish.
- No evidence of distant metastatic disease progression, evaluated by CT Thorax / Abdomen / Pelvis and/or PET-CT scan;
- Performance status WHO 0-2.
Key exclusion criteria (4 listed)
- Contra-indications for MRI or CT with an intravenous contrast agent according to the protocol of the local radiology and/or radiotherapy departments
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 |
|---|---|---|
| MR guided radiotherapy5 fractions of 10 Gray MRgRT in addition to standard of care | Radiation | Intervention arm |
Primary outcome
HRQoL deterioration-free survival
Time frame: Through study completion, an average of 18 months
HRQoL deterioration-free survival is defined as the Time Until Definitive Deterioration (TUDD) including death from any cause, calculated from the time of randomization. HRQoL is primarily assessed using the EORTC QLQ-C30 (version 3.0) Summary Score.
15 secondary outcomes
Overall survival
Time frame: From the date of LAPC diagnosis untill either death from any cause or last follow-up, whichever came first, assessed up to 18 months
Patient reported Quality of Life EORTC QLQ-PAN26
Time frame: At baseline and at 2,4, weeks and subsequently every 2 months. Assessed through study completion, up to 18 months
Patient reported Quality of Life EORTC QLQ-C30
Time frame: At baseline and at 2,4, weeks and subsequently every 2 months. Assessed through study completion, up to 18 months
Patient reported Quality of Life EQ5D-5L
Time frame: At baseline and at 2,4, weeks and subsequently every 2 months. Assessed through study completion, up to 18 months
The need of subsequent treatments
Time frame: Through study completion, an average of 18 months
Treatment response assessed on CT-imaging (graded according to RECIST guidelines)
Time frame: with available imaging during 18 months follow-up
CA 19.9 response
Time frame: Through study completion, an average of 18 months
Trial@home monitoring related outcome: feasibility Withings Steel HR smartwatch
Time frame: Through study completion, an average of 18 months
Trial@home monitoring related outcome: feasibility Body+ scale
Time frame: Through study completion, an average of 18 months
Trial@home monitoring related outcome: feasibility Whitings Sleep
Time frame: Through study completion, an average of 18 months
Trial@home monitoring related outcome: feasibility ePRO application
Time frame: Through study completion, an average of 18 months
Trial@home monitoring related outcome: digital biomarkers
Time frame: Through study completion, an average of 18 months
Intervention arm related outcome toxicity
Time frame: Through study completion, an average of 18 months
Intervention arm related outcome, completion of therapy
Time frame: Through study completion, an average of 18 months
Intervention arm related outcome diffusion weighted images
Time frame: Through study completion, an average of 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 22 Feb 2024.
- Individual participant dataSharing planned: Yes. De-dentified data generated during the LAPSTAR trial will be made available to other researchers upon request from L.A. Daamen
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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.
L. A. Daamen, MD, PhD principal investigator
Regional Academic Cancer Center Utrecht (RACU)
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
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MR guided radiotherapy in people with Locally Advanced Pancreatic Adenocarcinoma, run by UMC Utrecht at 4 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 5 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: opening soon, as of the sponsor's last update on 22 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 Lois Daamen, MD, PhD (+ 316 51223276, L.a.daamen-3@umcutrecht.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HRQoL deterioration-free survival (time frame: Through study completion, an average of 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2024.