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NCT Number: NCT05585554

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Treatment and study plan

MRIdian

Radiation

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

Primary outcomes

  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 outcomes

  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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hailey Austin

CONTACT

[email protected]

719-924-2494

Sponsors and collaborators

Lead sponsor

Viewray Inc.

Industry

Registry information

Official study title

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

Acronym: LAP-ABLATE

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Oct 19, 2022
Registry last updated
Oct 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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