NCT05585554

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
267

participants targeted

Target at P75+ for not_applicable pancreatic-cancer

Timeline
31mo left

Started Jul 2023

Longer than P75 for not_applicable pancreatic-cancer

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress53%
Jul 2023Dec 2028

First Submitted

Initial submission to the registry

October 10, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 19, 2022

Completed
9 months until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2028

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

October 19, 2022

Status Verified

October 1, 2022

Enrollment Period

5.1 years

First QC Date

October 10, 2022

Last Update Submit

October 14, 2022

Conditions

Pancreatic Cancer

Keywords

Locally Advanced Pancreatic CancerSBRTRadiation TherapyMRIdianViewRay

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Progression-Free Survival (PFS)

    2-years

  • Local Control (LC)

    2-years

  • Regional Control (RC)

    2-years

  • Distant Metastasis Free Survival (DMFS)

    2-years

  • Patient Reported Quality of Life (QoL) using EORTC QLQ-C30 questionnaire

    3-months, 12-months, 24-months

  • +2 more secondary outcomes

Study Arms (2)

Ablative MRIdian SMART

EXPERIMENTAL

Induction Chemotherapy + MRIdian SMART 50 Gy in 5 fractions

Radiation: MRIdian

No ablative MRIdian SMART

NO INTERVENTION

Induction chemotherapy alone

Interventions

MRIdianRADIATION

Stereotactic MRI-guided On-table Adaptive Radiation Therapy delivered on MRIdian linac

Ablative MRIdian SMART

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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).

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 30932367BACKGROUND

  • 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.

    BACKGROUND

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Central Study Contacts

Hailey Austin

CONTACT

719-924-2494haustin@viewray.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2022

First Posted

October 19, 2022

Study Start

July 1, 2023

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

October 19, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share