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Span-C-SBRT for Pancreatic Cancer (Span-C)

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ClinicalTrials.gov Identifier: NCT03505229
Recruitment Status : Recruiting
First Posted : April 23, 2018
Last Update Posted : January 24, 2019
Sponsor:
Information provided by (Responsible Party):
Royal North Shore Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
High Risk Localised Pancreatic Cancer Radiation: Stereotactic Body Radiotherapy (SBRT) Not Applicable

Detailed Description:

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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Intervention Model Description: non randomised-single arm phase II
Masking: None (Open Label)
Masking Description: no masking
Primary Purpose: Treatment
Official Title: Stereotactic Body Radiotherapy [SBRT] for High Risk Localised Pancreatic Cancer: a Phase II Study of the Department of Radiation Oncology Royal North Shore Hospital (Span-C - SBRT for Pancreatic Cancer)
Actual Study Start Date : December 18, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/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.




Primary Outcome Measures :
  1. freedom of local failure [ Time Frame: 12 months from end of radiotherapy ]
    patient who do no have local failure


Secondary Outcome Measures :
  1. Incidence of SBRT treatment related adverse events in this group of patients [ Time Frame: Acute toxicity-from start of SBRT up to 3 months after SBRT. Late RT toxicity: from 3 months to 2 years after SBRT. ]
    assess acute and late radiotherapy toxicity using CTCAE version 4.3, to compare toxicity with conventional treatment

  2. Response to neoadjuvant treatments [ Time Frame: from date of surgery through to 24 months post surgery ]
    Determine by pathology and radiological response rates after neoadjuvant treatment,

  3. Feasibility of internal-external correlation model (MATT) [ Time Frame: during SBRT radiotherapy treatment ]
    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.

  4. Surgical complications [ Time Frame: 30 to 90 days post surgery ]
    To assess surgical complications

  5. Duration of hospital admission after surgery [ Time Frame: from date of surgery through study completion (ie 24 months) ]
    to assess extended stay in the hospital after surgery

  6. margin negative (R0) resection rate [ Time Frame: through study completion, average of 2 years ]
    to assess margin negative resection rate (i.e. response to treatment)

  7. median overall survival (OS) [ Time Frame: 12 months after treatment ]
    To assess median overall survival after treatment

  8. progression free survival (PFS) [ Time Frame: 12 months after treatment ]
    To assess the PFS rate after treatment

  9. Feasibility of Using Kilovoltage Intra-fraction Monitoring (KIM) to determine pancreas motion [ Time Frame: during SBRT radiotherapy treatment ]
    Determine 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.



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Ages Eligible for Study:   18 Years to 86 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03505229


Contacts
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Contact: Carol Kwong +61 2 9463 1339 carolyn.kwong@health.nsw.gov.au
Contact: Clare Banks +61 2 9463 1345 clare.banks@health.nsw.gov.au

Locations
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Australia, New South Wales
Royal North Shore Hospital Recruiting
St Leonards, New South Wales, Australia, 2065
Contact: Carol Kwong, RN    +6129463 1339    carolyn.kwong@health.nsw.gov.au   
Contact: Clare Banks, B.Sc(HIM)MPH    +6129463 1345    clare.banks@health.nsw.gov.au   
Sponsors and Collaborators
Royal North Shore Hospital
Investigators
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Principal Investigator: George Hruby, FRANZCR Northern Sydney Local Health District

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Responsible Party: Royal North Shore Hospital
ClinicalTrials.gov Identifier: NCT03505229     History of Changes
Other Study ID Numbers: Span-C
First Posted: April 23, 2018    Key Record Dates
Last Update Posted: January 24, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: aim to present study data in conferences and medical journals
Supporting Materials: Clinical Study Report (CSR)
Time Frame: end of trial after analysis

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases