Locally Advanced Pancreatic Cancer Treated With ABLAtivE Stereotactic MRI-guided Adaptive Radiation Therapy

Study Overview

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.

N/A

Pancreatic Cancer

RADIATION: MRIdian

LAP-ABLATE

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2022-10-10	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2022-10-14
First Submitted that Met QC Criteria 2022-10-14	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2022-10-19
First Posted (ACTUAL) 2022-10-19	Results First Posted N/A	Last Verified 2022-10

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/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

Participant Group/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

Primary Outcome Measures	Measure Description	Time Frame
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	2-years

Secondary Outcome Measures	Measure Description	Time Frame
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	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	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	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	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.	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.	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.	90 days

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Hailey Austin

Phone Number: 719-924-2494

Email: haustin@viewray.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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.
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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