Stereotactic Body Radiation Therapy for Inoperable Non-metastasized Pancreatic Adenocarcinoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCancer Research Antwerp
About this trial
This is a multicenter randomized phase II trial that aims to include 160 patients with a non-metastatic (localized), inoperable pancreatic tumor. The study will take place at multiple centers across Europe. The primary objective of the study is to demonstrate superiority in progression free survival (PFS) by adding stereotactic body radiation therapy (SBRT) to chemotherapy for patients with an inoperable non-metastasized pancreatic tumor. SBRT is a radiotherapy technique (i.e. destroying cancer cells by means of ionizing irradiation) in which tumors can be irradiated with a high radiation dose. Surrounding healthy tissue is thus spared to the maximum extent. The primary endpoint of the TORPEDO study is 2-year PFS defined as the percentage of patients who are free of disease progression at 110 weeks after the date when the patients were drawn into 2 treatment groups (i.e. randomization). Secondary outcomes are, among others, quality of life, acute and late toxicity (i.e. adverse events), metastasis-free survival, local progression-free survival, overall survival, subsequent resectability, R0 resection and surgical morbidity.
During the study, patients without disease progression after 3 months of induction chemotherapy will be randomized 1:1 to either treatment with chemotherapy or treatment with a combination of chemotherapy and SBRT (5 x 8 Gy). After randomization, ten-weekly follow-up visits will occur during two years to evaluate the quality of life, general blood parameters and general health condition of the patient. Moreover, toxicity will be evaluated as well as efficiency and safety of the treatment (e.g. by means of imaging). At any time during this follow-up period, imaging (CT scan, MRI scan) will be used to determine whether surgery can still be performed to improve patient survival.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participant must be over 18 years of age.
Participant is able and willing to provide written informed consent which includes compliance with and ability to undergo all study procedures and attend the scheduled follow-up visits per protocol.
Either locally advanced or borderline resectable pancreatic adenocarcinoma, as confirmed by diagnostic images (CT, MRI or PET-CT scan) and based on vessel involvement according to the NCCN guidelines. Only borderline resectable pancreatic cancer (BRPC) patients who are medically unfit for surgery or refusing surgery can be included.
Adequate bone marrow function: absolute neutrophil count ≥1500/mm^3, platelet count ≥100000/mm^3 and hemoglobin ≥9 g/dl
Disqualifiers
Extrapancreatic metastatic disease as defined on diagnostic imaging (CT, MRI or PET-CT scan) or laparoscopy, including distal nodal involvement beyond the peripancreatic tissues and/or distant metastases.
Massive gastric or intestinal invasion as assessed on imaging and/or endoscopy. Direct invasion of the duodenal mucosa as visible on endoscopic ultrasound (EUS).
Prior radiation therapy that could hamper adequate dose delivery
Contraindication to magnetic resonance imaging (MRI)
Trial design
Design model
Parallel
Treatments tested in this trial
Stereotactic Body Radiation Therapy (SBRT)
RadiationSBRT (5 x 8 Gy)
Chemotherapy
DrugStandard of care: mFOLFIRINOX or gemcitabine/nab-paclitaxel
Treatment groups
160 Participants
are divided into 2 treatment groupsGroup A: Arm A: Chemotherapy aloneActive comparator 1 intervention
Group B: Arm B: Chemotherapy with SBRTExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
2-year progression-free survival
2-year progression-free survival (PFS): defined as the percentage of patients who are free of disease progression at 110 weeks (+/- 1 week) after the date of randomization. Events considered as progression are: * Disease progression per RECIST 1.1 with the exception of cases determined as pseudoprogression at the first response assessment (i.e. at 10w +/- 1w after randomization). * Discovery of hepatic or peritoneal carcinomatosis during surgical exploration * Recurrent disease following R0/R1 resection * Death due to any cause
Time frame
From randomization until 110 weeks (+/- 1 week) after the date of randomization, assessed up to 110 weeks (+/- 1 week).Secondary outcomes
1
Metastasis-free survival (MFS)
Survival without metastases
Time frame
Measured from the date of randomization to time of distant metastasis, assessed up to 110 weeks (+/- 1 week)2
Local progression-free survival (LPFS)
Locoregional progression is defined as any progressive or recurrent pancreatic tumor at the original tumor location or the N1-2 lymph node areas (with the only exception of cases determined as pseudoprogression at the first restaging post SBRT).
Time frame
Measured from the date of randomization to locoregional progression, assessed up to 110 weeks (+/- 1 week).3
Overall survival (OS)
Overall survival
Time frame
Measured from the date of randomization to the date of death or last known follow-up date, assessed up to 6 years4
R0 resection rate
R0 resection rate is measured as the percentage of patients undergoing R0 resection. R0-resection is defined as a tumor-free margin of at least 1mm from the resection margins, with the exception for the anterior resection margin for which R0-resection is defined as the absence of tumor cells in the inked surface of the resection specimen.
Time frame
Measured at the moment surgery took place (if surgery took place)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Cancer Research Antwerp
Lead sponsor
Kom Op Tegen Kanker
Collaborator
Naslund Medical AB
Collaborator
Varian Medical Systems
Collaborator
Source ClinicalTrials.gov