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Locally Advanced Pancreatic Cancer Treated With ABLAtivE Stereotactic MRI-guided Adaptive Radiation Therapy (LAP-ABLATE)

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ClinicalTrials.gov Identifier: NCT05585554
Recruitment Status : Not yet recruiting
First Posted : October 19, 2022
Last Update Posted : October 19, 2022
Sponsor:
Information provided by (Responsible Party):
Viewray Inc.

Study Description
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Brief 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 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.


Condition or disease Intervention/treatment Phase
Pancreatic Cancer Radiation: MRIdian Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 267 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Locally Advanced Pancreatic Cancer Treated With ABLAtivE Stereotactic MRI-guided Adaptive Radiation Therapy (LAP-ABLATE)
Estimated Study Start Date : July 2023
Estimated Primary Completion Date : August 2028
Estimated Study Completion Date : December 2028

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Ablative MRIdian SMART
Induction Chemotherapy + MRIdian SMART 50 Gy in 5 fractions
 Radiation: MRIdian
Stereotactic MRI-guided On-table Adaptive Radiation Therapy delivered on MRIdian linac
No Intervention: No ablative MRIdian SMART
Induction chemotherapy alone


Outcome Measures
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Primary Outcome Measures :
  1. 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



Secondary Outcome Measures :
  1. Progression-Free Survival (PFS) [ Time Frame: 2-years ]

    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


  2. Local Control (LC) [ Time Frame: 2-years ]

    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


  3. Regional Control (RC) [ Time Frame: 2-years ]

    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


  4. Distant Metastasis Free Survival (DMFS) [ Time Frame: 2-years ]

    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


  5. Patient Reported Quality of Life (QoL) using EORTC QLQ-C30 questionnaire [ Time Frame: 3-months, 12-months, 24-months ]

    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.


  6. Patient Reported Quality of Life (QoL) using EORTC QLQ-PAN26 questionnaire [ Time Frame: 3-months, 12-months, 24-months ]

    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.


  7. Treatment-related toxicity [ Time Frame: 90 days ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Locally advanced pancreatic adenocarcinoma or adenosquamous carcinoma as defined by NCCN guidelines.
  2. Minimum of 4 months interval from chemotherapy start to administration of the last dose/chemo.
  3. Minimum 8 cycles of (m)FOLFIRINOX OR 12 doses of gemcitabine/nab - paclitaxel)
  4. No radiographic evidence of local or distant disease progression at any time prior to study enrollment after starting chemotherapy
  5. At least 18 years of age
  6. ECOG performance status ≤ 1

  7. Adequate bone marrow and organ function as defined below:

    1. Absolute neutrophil count ≥ 1,000/mcL
    2. Platelets ≥ 75,000/mcL
    3. Hemoglobin ≥ 8.0 g/dL
    4. Total bilirubin ≤ 1.5 x IULN
    5. AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN
  8. 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.
  9. Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).

Exclusion Criteria:

  1. CA19-9 > 180 U/mL within 30 days of randomization.
  2. Any prior abdominal radiation therapy.
  3. 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).
  4. Currently receiving any other investigational agents.
  5. More than one cytotoxic regimen given for pancreatic cancer.
  6. Major abdominal surgery within 4 weeks prior to randomization.
  7. Definitive surgery for pancreas cancer completed prior to study enrollment (e.g., Whipple procedure).
  8. Subject with planned or scheduled definitive surgery for pancreas at time of study enrollment
  9. Grade 3 or greater toxicity during induction chemotherapy that has not resolved to at least grade 2
  10. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
  11. Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry.
  12. Medical/psychological contraindication to having an MRI scan.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05585554


Contacts
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Contact: Hailey Austin 719-924-2494 haustin@viewray.com

Sponsors and Collaborators
Viewray Inc.
More Information
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Publications:
Eaton 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.

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Responsible Party: Viewray Inc.
ClinicalTrials.gov Identifier: NCT05585554    
Other Study ID Numbers: LAP-ABLATE
First Posted: October 19, 2022    Key Record Dates
Last Update Posted: October 19, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Viewray Inc.:
Locally Advanced Pancreatic Cancer
SBRT
Radiation Therapy
MRIdian
ViewRay
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases