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

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Brief Title

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

Official Title

Prospective Phase II Study of Stereotactic Magnetic Resonance Imaging (MRI) Guided On-table Adaptive Radiation Therapy (SMART) for Patients With Borderline or Inoperable Locally Advanced Pancreatic Cancer

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.
    

Detailed Description

      Prior stereotactic body radiotherapy (SBRT) experiences for treatment of locally advanced
      pancreatic cancer entailed either single-fraction or multi-fraction approaches delivering 33
      Gray (Gy) in 5 fractions. Excellent tolerance and tumor control has been demonstrated, but
      median survival remained approximately 14 months. This highlights the strengths and
      limitations of SBRT to current radiation doses for pancreatic cancer. A prior Washington
      University institutional study and retrospective review has shown the safety of delivering
      67.5 Gy in 15 fractions for inoperable pancreatic cancer using a strict 'isotoxicity'
      approach of limiting the gastrointestinal (GI) organs at risk (stomach, duodenum, small bowel
      and large bowel) to 45 Gy to 0.5 cm3 or less. This regimen resulted in no grade 3 or higher
      GI toxicities, and only one death in the 19 patients with a median follow-up of 15 months.
      This is significantly improved from prior experiences, where approximately 15 months
      represents the median survival for most studies of inoperable pancreatic cancer.

      A recent retrospective analysis of 42 locally advanced pancreatic cancer patients treated by
      magnetic resonance imaging (MRI) guided radiation therapy at four institutions (University of
      California, Los Angeles, University of Wisconsin, Vrije Universiteit Medical Center (VUmc),
      Amsterdam, and Washington University, St. Louis) demonstrated that high-dose stereotactic
      body radiotherapy (SBRT) or hypofractionated radiation therapy delivered using daily ADAPTIVE
      dose planning on an MRI-guided radiotherapy system (MRIdian, ViewRay Inc.) has the potential
      to further improve overall survival. A control group of 19 patients treated to more
      conventional radiation doses without frequent dose adaptation showed a median survival of
      14.8 months, while patients treated to high radiation doses (n=23, maximum biologically
      equivalent dose at alpha/beta = 10 Gy, or BED10 of > 90 Gy) under daily or almost daily
      adaptive re-planning had an estimated median survival of 27.8 months (p=0.005).
      Interestingly, increased radiation dose delivery using daily dose adaptation was correlated
      with less grade 3 toxicity (0% in the high dose group vs 15.8% in patients treated to lower
      radiation doses without dose adaptation).

      The compelling data of this retrospective study prompted the development of this current
      prospective clinical trial designed to assess the primary objective of grade 3 or greater GI
      toxicity at 90 days for patients with borderline resectable or inoperable locally advanced
      pancreatic cancer treated with MRI-guided on-table adaptive radiation therapy and soft tissue
      tracking with radiation beam gating to 50 Gy in 5 fractions. Secondary objectives include
      assessment of (1) overall survival at 2 years, (2) distant progression free survival at 6
      months, and (3) changes in patient-reported quality of life (QOL) from pre-treatment to 3 and
      12 months post-treatment.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

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

Secondary Outcome

 Overall survival

Condition

Pancreatic Cancer

Intervention

Stereotactic MRI-guided On-table Adaptive Radiation Therapy


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Radiation

Estimated Enrollment

133

Start Date

January 1, 2019

Completion Date

January 2026

Primary Completion Date

May 2021

Eligibility Criteria

        Inclusion Criteria:

          1. 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.

          2. Greater than or equal to 3 months of systemic chemotherapy

          3. At least 18 years of age.

          4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1

          5. Normal bone marrow and organ function as defined below:

               1. Absolute neutrophil count ≥ 500/mcL (microliters)

               2. Platelets ≥ 50,000/mcL

               3. Hemoglobin ≥ 8.0 g/dL (deciliters)

               4. Total bilirubin ≤ 1.5 x IULN

               5. Aspartate Aminotransferase AST(SGOT) / Alanine Aminotransferase ALT(SGPT) ≤ 3.0 x
                  Institutional Upper Limit of Normal (IULN)

          6. 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.

          7. 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).

        Exclusion Criteria:

          1. 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

          2. Carbohydrate antigen (CA19.9) > 500 U/ml.

          3. Prior radiotherapy to the region of the study cancer that would result in overlap of
             radiation therapy fields.

          4. Currently receiving any other investigational agents.

          5. Major surgery within 4 weeks prior to first day of treatment.

          6. Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac
             arrhythmia.

          7. Pregnant and/or breastfeeding. Women of childbearing potential must have a negative
             pregnancy test within 14 days of study entry.

          8. Medical/psychological contraindication to magnetic resonance imaging (MRI).
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Parag J Parikh, MD, 612-412-7389, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03621644

Organization ID

VR C2T2 - SMART - LAPC/BRPC 1


Responsible Party

Sponsor

Study Sponsor

Viewray Inc.


Study Sponsor

Parag J Parikh, MD, Principal Investigator, Henry Ford Health System


Verification Date

January 2020