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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03505229




Registration number
NCT03505229
Ethics application status
Date submitted
5/03/2018
Date registered
16/04/2018
Date last updated
22/01/2019

Titles & IDs
Public title
Span-C-SBRT for Pancreatic Cancer
Scientific 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)
Secondary ID [1] 0 0
Span-C
Universal Trial Number (UTN)
Trial acronym
Span-C
Linked study record

Health condition
Health condition(s) or problem(s) studied:
High Risk Localised Pancreatic Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Pancreatic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Stereotactic Body Radiotherapy (SBRT)

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.


Treatment: Other: Stereotactic Body Radiotherapy (SBRT)
Stereotactic Body Radiotherapy (SBRT) 30-45 gray in 5 fractions over 2 weeks will be given to all eligible patients.

Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
freedom of local failure - patient who do no have local failure
Timepoint [1] 0 0
12 months from end of radiotherapy
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
Acute toxicity-from start of SBRT up to 3 months after SBRT. Late RT toxicity: from 3 months to 2 years after SBRT.
Secondary outcome [2] 0 0
Response to neoadjuvant treatments - Determine by pathology and radiological response rates after neoadjuvant treatment,
Timepoint [2] 0 0
from date of surgery through to 24 months post surgery
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
during SBRT radiotherapy treatment
Secondary outcome [4] 0 0
Surgical complications - To assess surgical complications
Timepoint [4] 0 0
30 to 90 days post surgery
Secondary outcome [5] 0 0
Duration of hospital admission after surgery - to assess extended stay in the hospital after surgery
Timepoint [5] 0 0
from date of surgery through study completion (ie 24 months)
Secondary outcome [6] 0 0
margin negative (R0) resection rate - to assess margin negative resection rate (i.e. response to treatment)
Timepoint [6] 0 0
through study completion, average of 2 years
Secondary outcome [7] 0 0
median overall survival (OS) - To assess median overall survival after treatment
Timepoint [7] 0 0
12 months after treatment
Secondary outcome [8] 0 0
progression free survival (PFS) - To assess the PFS rate after treatment
Timepoint [8] 0 0
12 months after treatment
Secondary outcome [9] 0 0
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.
Timepoint [9] 0 0
during SBRT radiotherapy treatment

Eligibility
Key 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
Minimum age
18 Years
Maximum age
86 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 0 0
2065 - St Leonards

Funding & Sponsors
Primary sponsor type
Other
Name
Royal North Shore Hospital
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT03505229
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
George Hruby, FRANZCR
Address 0 0
Northern Sydney Local Health District
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Carol Kwong
Address 0 0
Country 0 0
Phone 0 0
+61 2 9463 1339
Fax 0 0
Email 0 0
carolyn.kwong@health.nsw.gov.au
Contact person for scientific queries

No data has been provided for results reporting
Summary results
Not applicable