Stereotactic MRI-guided On-table Adaptive Radiation Therapy (SMART) for Locally Advanced Pancreatic Cancer

NCT03621644 | Active Not Recruiting DMC FDA Device

• 1 other identifier: VR C2T2 - SMART - LAPC/BRPC 1
• Study Type: interventional
• Target: 133
• Locations: 2 countries
• Sites: 13

Brief Summary

High-dose magnetic resonance imaging (MRI) guided hypofractionated radiation therapy delivered using daily adaptive dose planning has been shown in a retrospective study to result in improved 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 goal of the proposed trial is to investigative in a controlled, prospective manner the robustness of this outcome, and to track quality of life over a 5-year trial period.

Conditions

Pancreatic Cancer

Keywords

Pancreatic Cancer; Radiation Therapy; SBRT

Outcome Measures

Primary Outcomes (1)

• Gastrointestinal toxicity assessed using Common Terminology Criteria for Adverse Events (CTCAE) v5

  Grade 3 or higher gastrointestinal toxicity assessed using Common Terminology Criteria for Adverse Events (CTCAE) v5 within 90 days of completion of radiation therapy

  90 days

Secondary Outcomes (3)

• Overall survival

  2 years

• Distant progression-free survival

  6 months

• Patient-reported quality of life (QOL)

  3 and 12 months

Study Arms (1)

Ablative MRIdian SMART

EXPERIMENTAL

Radiation: Stereotactic MRI-guided On-table Adaptive Radiation Therapy 50 Gy in 5 fractions

Radiation: Stereotactic MRI-guided On-table Adaptive Radiation Therapy

Interventions

Stereotactic MRI-guided On-table Adaptive Radiation Therapy RADIATION

Radiation therapy will be delivered with an integrated magnetic resonance imaging (MRI)-guided radiotherapy delivery system (ViewRay MRIdian or MRIdian Linac). The prescribed dose will be 50 Gray (Gy) in 5 fractions. Stereotactic body radiotherapy (SBRT) fractions will be delivered at least twice per week, and with at least 18 hours between fractions. Each participant will be aligned in the treatment system with MRI image-guidance. On-table adaptive re-planning will be used when clinically indicated. In all patients, real-time MRI imaging will be used throughout treatment delivery to monitor the target location and control the radiation beam as necessary.

Ablative MRIdian SMART

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed locally advanced adenocarcinoma of the pancreas that is considered unresectable or borderline resectable on institutional standardized criteria of unresectability or medical inoperability. Patients with and without regional adenopathy are eligible as long as lymph nodes are adjacent to primary tumor.
• Greater than or equal to 3 months of systemic chemotherapy
• At least 18 years of age.
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
• Normal bone marrow and organ function as defined below:
• Absolute neutrophil count ≥ 500/mcL (microliters)
• Platelets ≥ 50,000/mcL
• Hemoglobin ≥ 8.0 g/dL (deciliters)
• Total bilirubin ≤ 1.5 x IULN
• Aspartate Aminotransferase AST(SGOT) / Alanine Aminotransferase ALT(SGPT) ≤ 3.0 x Institutional Upper Limit of Normal (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 Institutional Review Board (IRB) approved written informed consent document (or that of legally authorized representative, if applicable).

You may not qualify if:

• Distant metastatic disease as assessed by staging positron emission tomography / computed tomography (PET/CT) or CT of the chest and abdomen within 6 weeks of starting radiation therapy
• Carbohydrate antigen (CA19.9) \> 500 U/ml.
• Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields.
• Currently receiving any other investigational agents.
• Major surgery within 4 weeks prior to first day of treatment.
• 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 magnetic resonance imaging (MRI).

Sponsors & Collaborators

• Viewray Inc.: lead

Study Sites (13)

UCLA

Los Angeles, California, 90095, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

Miami Cancer Institute

Miami, Florida, 33176, United States

Location

Orlando Health

Orlando, Florida, 32806, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Henry Ford Health Sciences

Detroit, Michigan, 48202, United States

Location

Washington University

St Louis, Missouri, 63108, United States

Location

Dartmouth-Hitchcock

Lebanon, New Hampshire, 03756, United States

Location

Cornell University

New York, New York, 10065, United States

Location

Providence Portland Cancer Center

Portland, Oregon, 97213, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

University of Wisconisin

Madison, Wisconsin, 53792, United States

Location

Assuta Medical Center

Tel Aviv, Israel

Location

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: 30932367 BACKGROUND

• Parikh PJ, Lee P, Low DA, Kim J, Mittauer KE, Bassetti MF, Glide-Hurst CK, Raldow AC, Yang Y, Portelance L, Padgett KR, Zaki B, Zhang R, Kim H, Henke LE, Price AT, Mancias JD, Williams CL, Ng J, Pennell R, Pfeffer MR, Levin D, Mueller AC, Mooney KE, Kelly P, Shah AP, Boldrini L, Placidi L, Fuss M, Chuong MD. A Multi-Institutional Phase 2 Trial of Ablative 5-Fraction Stereotactic Magnetic Resonance-Guided On-Table Adaptive Radiation Therapy for Borderline Resectable and Locally Advanced Pancreatic Cancer. Int J Radiat Oncol Biol Phys. 2023 Nov 15;117(4):799-808. doi: 10.1016/j.ijrobp.2023.05.023. Epub 2023 May 19.

  PMID: 37210048 DERIVED

Related Links

• Parag Parikh, MD: Improving Pancreatic Cancer Survival by using MR Guided Adaptive Radiation

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Parag J Parikh, MD

  Henry Ford Health System

  PRINCIPAL INVESTIGATOR

• Percy Lee, MD

  MD Anderson

  PRINCIPAL INVESTIGATOR

• Daniel Low, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

• Michael Chuong, MD

  Miami Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2018
• First Posted: August 8, 2018
• Study Start: January 1, 2019
• Primary Completion: August 3, 2022
• Study Completion (Estimated): January 1, 2027
• Last Updated: October 14, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (12); IL (1)