Span-C-SBRT for Pancreatic Cancer

Royal North Shore Hospital

Status: Enrolling

Conditions: High Risk Localised Pancreatic Cancer

Treatments: Radiation: Stereotactic Body Radiotherapy (SBRT)

Study type: Interventional

Funder types: Other

Identifiers

NCT03505229

Span-C

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 86 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Stereotactic Body Radiotherapy (SBRT)

Experimental group

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.

Treatment:

Radiation: Stereotactic Body Radiotherapy (SBRT)