search
Back to results

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

Primary Purpose

High Risk Localised Pancreatic Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Stereotactic Body Radiotherapy (SBRT)
Sponsored by
Royal North Shore Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for High Risk Localised Pancreatic Cancer

Eligibility Criteria

18 Years - 86 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Royal North Shore HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Stereotactic Body Radiotherapy (SBRT)

Arm Description

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.

Outcomes

Primary Outcome Measures

freedom of local failure
patient who do no have local failure

Secondary Outcome Measures

Incidence of SBRT treatment related adverse events in this group of patients
assess acute and late radiotherapy toxicity using CTCAE version 4.3, to compare toxicity with conventional treatment
Response to neoadjuvant treatments
Determine by pathology and radiological response rates after neoadjuvant treatment,
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.
Surgical complications
To assess surgical complications
Duration of hospital admission after surgery
to assess extended stay in the hospital after surgery
margin negative (R0) resection rate
to assess margin negative resection rate (i.e. response to treatment)
median overall survival (OS)
To assess median overall survival after treatment
progression free survival (PFS)
To assess the PFS rate after treatment
Feasibility of Using Kilovoltage Intra-fraction Monitoring (KIM) to determine pancreas motion
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.

Full Information

First Posted
March 5, 2018
Last Updated
October 25, 2022
Sponsor
Royal North Shore Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT03505229
Brief Title
Span-C-SBRT for Pancreatic Cancer
Acronym
Span-C
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 18, 2018 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Royal North Shore Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
High Risk Localised Pancreatic Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
non randomised-single arm phase II
Masking
None (Open Label)
Masking Description
no masking
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stereotactic Body Radiotherapy (SBRT)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
Stereotactic Body Radiotherapy (SBRT)
Intervention Description
Stereotactic Body Radiotherapy (SBRT) 30-45 gray in 5 fractions over 2 weeks will be given to all eligible patients.
Primary Outcome Measure Information:
Title
freedom of local failure
Description
patient who do no have local failure
Time Frame
12 months from end of radiotherapy
Secondary Outcome Measure Information:
Title
Incidence of SBRT treatment related adverse events in this group of patients
Description
assess acute and late radiotherapy toxicity using CTCAE version 4.3, to compare toxicity with conventional treatment
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.
Title
Response to neoadjuvant treatments
Description
Determine by pathology and radiological response rates after neoadjuvant treatment,
Time Frame
from date of surgery through to 24 months post surgery
Title
Feasibility of internal-external correlation model (MATT)
Description
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.
Time Frame
during SBRT radiotherapy treatment
Title
Surgical complications
Description
To assess surgical complications
Time Frame
30 to 90 days post surgery
Title
Duration of hospital admission after surgery
Description
to assess extended stay in the hospital after surgery
Time Frame
from date of surgery through study completion (ie 24 months)
Title
margin negative (R0) resection rate
Description
to assess margin negative resection rate (i.e. response to treatment)
Time Frame
through study completion, average of 2 years
Title
median overall survival (OS)
Description
To assess median overall survival after treatment
Time Frame
12 months after treatment
Title
progression free survival (PFS)
Description
To assess the PFS rate after treatment
Time Frame
12 months after treatment
Title
Feasibility of Using Kilovoltage Intra-fraction Monitoring (KIM) to determine pancreas motion
Description
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.
Time Frame
during SBRT radiotherapy treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
86 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carol Kwong
Phone
+61 2 9463 1339
Email
carolyn.kwong@health.nsw.gov.au
First Name & Middle Initial & Last Name or Official Title & Degree
Heidi Tsang
Phone
+61 2 9463 1340
Email
heidi.tsang@health.nsw.gov.au
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George Hruby, FRANZCR
Organizational Affiliation
Northern Sydney Local Health District
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal North Shore Hospital
City
St Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carol Kwong, RN
Phone
+6129463 1339
Email
carolyn.kwong@health.nsw.gov.au
First Name & Middle Initial & Last Name & Degree
Heidi Tsang, RN
Phone
+61294631340
Email
heidi.tsang@health.nsw.gov.au

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
aim to present study data in conferences and medical journals
IPD Sharing Time Frame
end of trial after analysis

Learn more about this trial

Span-C-SBRT for Pancreatic Cancer

We'll reach out to this number within 24 hrs