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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03505229
Ethics application status
Date submitted
5/03/2018
Date registered
23/04/2018

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
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
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
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)
Timepoint [3] 0 0
during SBRT radiotherapy treatment
Secondary outcome [4] 0 0
Surgical complications
Timepoint [4] 0 0
30 to 90 days post surgery
Secondary outcome [5] 0 0
Duration of hospital admission 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
Timepoint [6] 0 0
through study completion, average of 2 years
Secondary outcome [7] 0 0
median overall survival (OS)
Timepoint [7] 0 0
12 months after treatment
Secondary outcome [8] 0 0
progression free survival (PFS)
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
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
Sex
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
NA
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
NA
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
18/12/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
5/10/2028
Actual
Sample size
Target
40
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
Trial website
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
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
aim to present study data in conferences and medical journals

Supporting document/s available: Clinical study report (CSR)
When will data be available (start and end dates)?
end of trial after analysis
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03505229