Pancreatic CancerLAP-ABLATENCT05585554
Locally Advanced Pancreatic Cancer Treated With ABLAtivE Stereotactic MRI-guided Adaptive Radiation Therapy
A study testing MRIdian in people with Pancreatic Cancer, run by Viewray Inc..
Trial summary
Ablative dose magnetic resonance imaging (MRI) guided hypofractionated radiation therapy delivered using daily adaptive dose planning has shown to improve overall survival, relative to patients receiving lower radiation doses, in patients with locally advanced pancreatic cancer, without increasing the rate of serious… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- MRIdian
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 267 participants
- Where
- No sites listed yet
- Study dates
- Jul 2023to Dec 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
- Locally advanced pancreatic adenocarcinoma or adenosquamous carcinoma as defined by NCCN guidelines.
- Minimum of 4 months interval from chemotherapy start to administration of the last dose/chemo.
- Minimum 8 cycles of (m)FOLFIRINOX OR 12 doses of gemcitabine/nab - paclitaxel)
- No radiographic evidence of local or distant disease progression at any time prior to study enrollment after starting chemotherapy
- At least 18 years of age
- ECOG performance status ≤ 1
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- Adequate bone marrow and organ function as defined below:
- Absolute neutrophil count ≥ 1,000/mcL
- Platelets ≥ 75,000/mcL
- Hemoglobin ≥ 8.0 g/dL
- Total bilirubin ≤ 1.5 x IULN
- AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN
- Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
- Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).
Who cannot join
- CA19-9 > 180 U/mL within 30 days of randomization.
- Any prior abdominal radiation therapy.
- History of prior malignancy with the exception of: 1) malignancy treated with curative intent and with no known disease for at least 2 years from treatment to study enrollment, 2) adequately treated carcinoma in situ without evidence of disease (i.e. superficial bladder cancer).
- Currently receiving any other investigational agents.
- More than one cytotoxic regimen given for pancreatic cancer.
- Major abdominal surgery within 4 weeks prior to randomization.
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- Definitive surgery for pancreas cancer completed prior to study enrollment (e.g., Whipple procedure).
- Subject with planned or scheduled definitive surgery for pancreas at time of study enrollment
- Grade 3 or greater toxicity during induction chemotherapy that has not resolved to at least grade 2
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
- Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry.
- Medical/psychological contraindication to having an MRI scan.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Locally Advanced Pancreatic Cancer Treated With ABLAtivE Stereotactic MRI-guided Adaptive Radiation Therapy (LAP-ABLATE)
Ablative dose magnetic resonance imaging (MRI) guided hypofractionated radiation therapy delivered using daily adaptive dose planning has shown to improve overall survival, relative to patients receiving lower radiation doses, in patients with locally advanced pancreatic cancer, without increasing the rate of serious gastrointestinal toxicity. The next step is to determine how these results compare to chemotherapy alone.
This is a prospective, randomized controlled trial (2:1) comparing induction chemotherapy followed by ablative Stereotactic MR-guided on-table Adaptive Radiation Therapy (SMART) versus chemotherapy alone in locally advanced pancreatic cancer patients. Overall survival outcomes at 2-years will be evaluated.
- Conditions
- Pancreatic Cancer
- Being tested
- MRIdian
- Keywords
- Locally Advanced Pancreatic Cancer, SBRT, Radiation Therapy, MRIdian, ViewRay
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIdianRadiation
Stereotactic MRI-guided On-table Adaptive Radiation Therapy delivered on MRIdian linac
| Study group | Role | What they receive |
|---|---|---|
| Ablative MRIdian SMART | Experimental | Induction Chemotherapy + MRIdian SMART 50 Gy in 5 fractions Receives: Radiation: MRIdian |
| No ablative MRIdian SMART | No intervention | Induction chemotherapy alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
To demonstrate superior 2-year overall survival from date of randomization in ablative MRIdian SMART versus no ablative MRIdian SMART in locally advanced pancreatic cancer patients without disease progression after induction chemotherapy.
A Kaplan-Meier survival curve will be used to report the fraction of subjects living throughout the study
Measured: 2-years
Secondary outcomes (7)
Progression-Free Survival (PFS)
To demonstrate superior progression-free survival at 2 years from date of randomization in ablative MRIdian SMART therapy versus no ablative MRIdian SMART therapy in locally advanced pancreatic cancer patients without disease progression after induction chemotherapy.
A Kaplan-Meier survival curve will be used to report percentage of patients living with pancreatic cancer without disease progression
Measured: 2-years
Local Control (LC)
To compare local control at 2 years from date of randomization in ablative MRIdian SMART therapy versus no ablative MRIdian SMART therapy in locally advanced pancreatic cancer patients without disease progression after induction chemotherapy.
A Kaplan-Meier curve will be used to report percentage of patients with local control of pancreatic cancer
Measured: 2-years
Regional Control (RC)
To compare regional control at 2 years from date of randomization in ablative MRIdian SMART therapy versus no ablative MRIdian SMART therapy in locally advanced pancreatic cancer patients without disease progression after induction chemotherapy.
A Kaplan-Meier curve will be used to report percentage of patients with regional control of pancreatic cancer
Measured: 2-years
Distant Metastasis Free Survival (DMFS)
To compare distant metastasis free survival at 2 years from date of randomization in ablative MRIdian SMART therapy versus no ablative MRIdian SMART therapy locally advanced pancreatic cancer patients without disease progression after induction chemotherapy
A Kaplan-Meier survival curve will be used to report percentage of patients living with pancreatic cancer without distant metastasis
Measured: 2-years
Patient Reported Quality of Life (QoL) using EORTC QLQ-C30 questionnaire
To determine changes in patient-reported quality of life in patients diagnosed with locally advanced pancreatic cancer randomized post-chemotherapy with no disease progression in both study groups.
The EORTC QLQ-C30 Scoring Manual will be followed for scoring.
The QLQ-C30 consists of 28 four-level Likert items (on a scale of 1 - "Not at all" to 4 - "Very much"), and two seven-level Likert items which are scored according to the EORTC scoring guidelines into the 15 domains (Overall health and quality of life on a scale of 1 - "Very Poor" to "7 - Excellent").
High scores in the 28 four-level Likert items indicate worse symptoms and health related QoL.
High scores in the two seven-level Likert items indicate better health and quality of life related QoL.
Measured: 3-months, 12-months, 24-months
Patient Reported Quality of Life (QoL) using EORTC QLQ-PAN26 questionnaire
To determine changes in patient-reported quality of life in patients diagnosed with locally advanced pancreatic cancer randomized post-chemotherapy with no disease progression in both study groups.
The EORTC QLQ-C30 Scoring Manual will be followed for the supplemental QLQ-PAN26 module.
The QLQ-PAN26 consists of 26 four-level Likert items (on a scale of 1 - "Not at all" to 4 - "Very much") which are scored according to draft scoring procedures supplied by EORTC to obtain seven multi-item scale scores consisting of two to four items and nine single-item scores.
Higher scores indicate worse symptoms, function and health related QoL.
Measured: 3-months, 12-months, 24-months
Treatment-related toxicity
To evaluate acute grade 3 or greater treatment-related toxicity (assessed using Common Terminology Criteria for Adverse Events (CTCAE) v5) from randomization in patients diagnosed with locally advanced pancreatic cancer randomized post-chemotherapy with no disease progression in both study groups.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2022
- Study startJul 2023 (estimated)
- Primary completionAug 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies 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
- Masking
- None (open label)
- Enrolment
- 267 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Viewray Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05585554
- Sponsor's protocol ID
- LAP-ABLATE
- Acronym
- LAP-ABLATE
- Status last verified
- Oct 2022
- First submitted
- 10 Oct 2022
- Last updated
- 19 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Rudra S, Jiang N, Rosenberg SA, Olsen JR, Roach MC, Wan L, Portelance L, Mellon EA, Bruynzeel A, Lagerwaard F, Bassetti MF, Parikh PJ, Lee PP. Using adaptive magnetic resonance image-guided radiation therapy for treatment of inoperable pancreatic cancer. Cancer Med. 2019 May;8(5):2123-2132. doi: 10.1002/cam4.2100. Epub 2019 Apr 1.
PubMed 30932367Eaton AA, Karanicolas P, Johnson MChir CD, Bottomley A, Allen PJ, Gonen M. Psychometric Validation of the EORTC QLQ-PAN26 Pancreatic Cancer Module for Assessing Health Related Quality of Life after Pancreatic Resection. JOP. J Pancreas (Online) 2017; 18(1):19-25.
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Locally Advanced Pancreatic Cancer Treated With ABLAtivE Stereotactic MRI-guided Adaptive Radiation Therapy (LAP-ABLATE)
- ClinicalTrials.gov ID
- NCT05585554
- Acronym / sponsor ID
- LAP-ABLATE / LAP-ABLATE
- Conditions
- Pancreatic Cancer
- Keywords
- Locally Advanced Pancreatic Cancer, SBRT, Radiation Therapy, MRIdian, ViewRay
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 267 participants (estimated)
- Lead sponsor
- Viewray Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2023 (estimated)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 19 Oct 2022 (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.
Ablative dose magnetic resonance imaging (MRI) guided hypofractionated radiation therapy delivered using daily adaptive dose planning has shown to improve overall survival, relative to patients receiving lower radiation doses, in patients with locally advanced pancreatic cancer, without increasing the rate of serious gastrointestinal toxicity. The next step is to determine how these results compare to chemotherapy alone.
This is a prospective, randomized controlled trial (2:1) comparing induction chemotherapy followed by ablative Stereotactic MR-guided on-table Adaptive Radiation Therapy (SMART) versus chemotherapy alone in locally advanced pancreatic cancer patients. Overall survival outcomes at 2-years will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ablative MRIdian SMART | Experimental | Radiation: MRIdianInduction Chemotherapy + MRIdian SMART 50 Gy in 5 fractions |
| No ablative MRIdian SMART | No intervention | –Induction chemotherapy alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Locally advanced pancreatic adenocarcinoma or adenosquamous carcinoma as defined by NCCN guidelines.
- Minimum of 4 months interval from chemotherapy start to administration of the last dose/chemo.
- Minimum 8 cycles of (m)FOLFIRINOX OR 12 doses of gemcitabine/nab - paclitaxel)
- No radiographic evidence of local or distant disease progression at any time prior to study enrollment after starting chemotherapy
- At least 18 years of age
Key exclusion criteria (12 listed)
- CA19-9 > 180 U/mL within 30 days of randomization.
- Any prior abdominal radiation therapy.
- History of prior malignancy with the exception of: 1) malignancy treated with curative intent and with no known disease for at least 2 years from treatment to study enrollment, 2) adequately treated carcinoma in situ without evidence of disease (i.e. superficial bladder cancer).
- Currently receiving any other investigational agents.
- More than one cytotoxic regimen given for pancreatic cancer.
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 |
|---|---|---|
| MRIdianStereotactic MRI-guided On-table Adaptive Radiation Therapy delivered on MRIdian linac | Radiation | Ablative MRIdian SMART |
Primary outcome
Overall Survival (OS)
Time frame: 2-years
To demonstrate superior 2-year overall survival from date of randomization in ablative MRIdian SMART versus no ablative MRIdian SMART in locally advanced pancreatic cancer patients without disease progression after induction chemotherapy. A Kaplan-Meier survival curve will be used to report the fraction of subjects living throughout the study
7 secondary outcomes
Progression-Free Survival (PFS)
Time frame: 2-years
Local Control (LC)
Time frame: 2-years
Regional Control (RC)
Time frame: 2-years
Distant Metastasis Free Survival (DMFS)
Time frame: 2-years
Patient Reported Quality of Life (QoL) using EORTC QLQ-C30 questionnaire
Time frame: 3-months, 12-months, 24-months
Patient Reported Quality of Life (QoL) using EORTC QLQ-PAN26 questionnaire
Time frame: 3-months, 12-months, 24-months
Treatment-related toxicity
Time frame: 90 days
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 19 Oct 2022.
- Background: PubMed 30932367Rudra S, Jiang N, Rosenberg SA, Olsen JR, Roach MC, Wan L, Portelance L, Mellon EA, Bruynzeel A, Lagerwaard F, Bassetti MF, Parikh PJ, Lee PP. Using adaptive magnetic resonance image-guided radiation therapy for treatment of inoperable pancreatic cancer. Cancer Med. 2019 May;8(5):2123-2132. doi: 10.1002/cam4.2100. Epub 2019 Apr 1.
- BackgroundEaton AA, Karanicolas P, Johnson MChir CD, Bottomley A, Allen PJ, Gonen M. Psychometric Validation of the EORTC QLQ-PAN26 Pancreatic Cancer Module for Assessing Health Related Quality of Life after Pancreatic Resection. JOP. J Pancreas (Online) 2017; 18(1):19-25.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing MRIdian in people with Pancreatic Cancer, run by Viewray Inc..
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 14 inclusion and 12 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 19 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
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 Hailey Austin (719-924-2494, haustin@viewray.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) (time frame: 2-years). 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 NCT05585554, which also lists 2 linked publications.
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 Oct 2022.