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 : September 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|High Risk Localised Pancreatic Cancer||Radiation: Stereotactic Body Radiotherapy (SBRT)||Not Applicable|
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.
|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|
|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|
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.
- freedom of local failure [ Time Frame: 12 months from end of radiotherapy ]patient who do no have local failure
- 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
- 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,
- 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.
- Surgical complications [ Time Frame: 30 to 90 days post surgery ]To assess surgical complications
- 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
- 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)
- median overall survival (OS) [ Time Frame: 12 months after treatment ]To assess median overall survival after treatment
- progression free survival (PFS) [ Time Frame: 12 months after treatment ]To assess the PFS rate after treatment
- 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.
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
|Contact: Carol Kwong||+61 2 9463 firstname.lastname@example.org|
|Contact: Clare Banks||+61 2 9463 email@example.com|
|Principal Investigator:||George Hruby, FRANZCR||Northern Sydney Local Health District|