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Span-C-SBRT for Pancreatic Cancer

RECRUITING

To assess the freedom from local failure at 12 months after Stereotactic Body Radiotherapy (SBRT). Also to assess the safety, efficacy and feasibility of SBRT in the treatment of high risk localised pancreatic cancer.

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Study details:

Patients must have histologically or cytologically confirmed high risk localised adenocarcinoma of the pancreas, including patients with extrapancreatic extension (Stage IIA), node positive (Stage IIB), borderline resectable or locally advanced pancreatic cancer as defined by Australasian Gastro-Intestinal Trials Group (AGITG) guidelines. ECOG performance status 0-1, suitable for chemotherapy and radiotherapy. After a minimum of 2 months of neoadjuvant chemotherapy using either an oxaliplatin- based regimen (FOLFOX, FOLFIRINOX, mFOLFIRINOX)+/- immunotherapy/molecular agent or gemcitabine based chemotherapy (eg gemcitabine / gemcitabine/abraxane).

Participants will receive SBRT (30-45Gray in 5 fractions over 2 weeks. Prior to SBRT, fiducial markers will be placed to aid with image guidance during radiation delivery. Four weeks after completion of SBRT participants will have re-staging using positron emission tomography (PET) and computed tomography (CT) scan.

Participants will be discussed in the multidisciplinary team meeting for consideration of surgery. Those considered to be resectable will proceed to have surgery 6-10 weeks post SBRT.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

  • Age ≥ 18 and able to give informed consent
  • Patients with histologically or cytologically confirmed locally advanced adenocarcinoma of the pancreas, including patients with extrapancreatic extension (Stage IIA), node positive (Stage IIB), borderline resectable or locally advanced as defined by AGITG guidelines
  • ECOG performance status 0-1
  • Measurable disease as defined by RECIST 1.1
  • Have received or plan to receive chemotherapy
  • Successful insertion of fiducial markers
  • Exclusion criteria

  • Patients with metastatic pancreas cancer
  • Prior abdominal radiotherapy
  • Active malignancy excluding non melanomatous skin cancer
  • Neuroendocrine pancreatic carcinoma
  • Pregnant or lactating women
  • Tumour size greater then 70mm
  • Age >85
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    Eligibility

    Age eligible for study : 18 and older

    Healthy volunteers accepted : No

    Gender eligible for study: All

    Things to know

    Study dates

    Study start: 2018-12-18

    Primary completion: 2028-10-05

    Study completion finish: 2028-10-05

    study type

    Study type

    TREATMENT

    phase

    Phase

      NA

    trial

    Trial ID

    NCT03505229

    Intervention or treatment

    RADIATION: Stereotactic Body Radiotherapy (SBRT)

    Conditions

    • High Risk Localised Pancreatic Cancer
    Image related to High Risk Localised Pancreatic Cancer
    • Condition: High Risk Localised Pancreatic Cancer

    • RADIATION: Stereotactic Body Radiotherapy (SBRT)

    • St Leonards, New South Wales, Australia

    • Sponsor: Royal North Shore Hospital

    Find a site

    Closest Location:

    Royal North Shore Hospital

    Research sites nearby

    Select from list below to view details:

    • Royal North Shore Hospital

      St Leonards, New South Wales, Australia

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    Study Plan

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

    How is the study designed?

    Participant Group/ArmIntervention/Treatment
    EXPERIMENTAL: Stereotactic Body Radiotherapy (SBRT)
    • Prior to SBRT, fiducial markers will be placed to aid with image guidance during radiation delivery. Fiducials will be inserted endoscopically (preferable) or intraoperatively. After this procedure, patients will have radiotherapy planning. During treatment, the fiducials will be used for registration with the images acquired during treatment (including kV fluoroscopy, MV or optical). The acquired images may be processed to determine fiducial location using KIM or MATT software from University of Sydney. SBRT 30-45Gray in 5 fractions will be given over 2 weeks.
    • Four weeks after completion of SBRT participants will repeat a re-staging PET and CT scans. Those considered to be resectable will proceed to have surgery 6-10 weeks post SBRT.
    RADIATION: Stereotactic Body Radiotherapy (SBRT)
    • Stereotactic Body Radiotherapy (SBRT) 30-45 gray in 5 fractions over 2 weeks will be given to all eligible patients.

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    freedom of local failurepatient who do no have local failure12 months from end of radiotherapy

    Secondary outcome

    Secondary Outcome MeasureSecondary Outcome DescriptionSecondary Outcome Time Frame
    Incidence of SBRT treatment related adverse events in this group of patientsassess acute and late radiotherapy toxicity using CTCAE version 4.3, to compare toxicity with conventional treatmentAcute toxicity-from start of SBRT up to 3 months after SBRT. Late RT toxicity: from 3 months to 2 years after SBRT.
    Response to neoadjuvant treatmentsDetermine by pathology and radiological response rates after neoadjuvant treatment,from date of surgery through to 24 months post surgery
    Feasibility of internal-external correlation model (MATT)Determine the feasibility of the University of Sydney internal-external correlation model (MATT) to determine pancreas motion. Feasibility is determined as predicted motion with MATT is within 2mm of actual motion measured with fluoroscopic x-rays of fiducial markers during treatment.during SBRT radiotherapy treatment
    Surgical complicationsTo assess surgical complications30 to 90 days post surgery
    Duration of hospital admission after surgeryto assess extended stay in the hospital after surgeryfrom date of surgery through study completion (ie 24 months)
    margin negative (R0) resection rateto assess margin negative resection rate (i.e. response to treatment)through study completion, average of 2 years
    median overall survival (OS)To assess median overall survival after treatment12 months after treatment
    progression free survival (PFS)To assess the PFS rate after treatment12 months after treatment
    Feasibility of Using Kilovoltage Intra-fraction Monitoring (KIM) to determine pancreas motionDetermine the feasibility of the University of Sydney Kilovoltage Intra-fraction Monitoring (KIM) software to determine pancreas motion. Feasibility is determined as predicted motion with KIM is within 2mm of actual motion measured with fluoroscopic x-rays of fiducial markers during treatment.during SBRT radiotherapy treatment

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    References

    Clinical Trials Gov: Span-C-SBRT for Pancreatic Cancer

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