Stereotactic Body Radiation Therapy for Inoperable Non-metastasized Pancreatic Adenocarcinoma

Launched by CANCER RESEARCH ANTWERP · Nov 14, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment approach for patients with a specific type of pancreatic cancer that cannot be surgically removed but has not spread to other parts of the body. The study aims to find out if adding a special type of radiation therapy called stereotactic body radiation therapy (SBRT) to standard chemotherapy can help patients live longer without their cancer worsening. The trial will involve about 160 participants from various centers across Europe, who will receive either chemotherapy alone or chemotherapy combined with SBRT.

To be eligible for this trial, participants must be at least 18 years old and have a confirmed diagnosis of unresectable pancreatic cancer. They should also have good overall health, meaning their organs are functioning well, and they can attend regular follow-up visits. Throughout the study, participants will receive treatment and then have imaging tests to check if surgery is possible afterward. They'll be monitored for side effects and their quality of life will be assessed over two years. This trial is important as it may offer new hope for patients facing this challenging diagnosis.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 organ function determined by the following laboratory values:
• • Adequate bone marrow function: absolute neutrophil count ≥1500/mm\^3, platelet count ≥100000/mm\^3 and hemoglobin ≥9 g/dl
• • Adequate renal function: Creatinine ≤1.5 x upper normal limit of normal (ULN) or estimated eGFR more than 45 ml/min
• • Adequate liver function: total bilirubin ≤1.5 ULN (after adequate biliairy stenting with metal stent) and alanine aminotransferase (ALT) ≤5x ULN
• • An Eastern Cooperative Oncology Group (ECOG) performance status grade of 0-2.
• • A life expectancy ≥3 months
• * A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies:
• • Is not a woman of child bearing potential or
• • A woman of child bearing potential must have a negative serum pregnancy test at screening and must use a very effective method of birth control.
• Exclusion Criteria:
• • 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)
• • Diagnosis of another malignancy within 2 years prior to randomization, except non-melanoma skin cancer, non-invasive bladder cancer, carcinoma in situ of the cervix or non-metastatic prostate cancer. Patients with a history of other malignancies are eligible if they have been continuously disease-free for at least 2 years after definitive primary treatment.
• • Any condition for which, in the opinion of the Investigator, participation would not be in the best interest of the subject.
• • Patient already included in another clinical trial that would interfere with the TORPEDO clinical trial, as assessed by the Investigator.
• • Known presence of an active ulcer (i.e. detected during standard of care diagnostic assessments)
• Additional exclusion criteria after restaging (i.e. within 1 week after 3 months of induction chemotherapy) and prior to randomization:
• • Extrapancreatic metastatic disease as defined on diagnostic imaging, 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 EUS.
• • Known presence of an active ulcer (i.e. detected during standard of care diagnostic assessments)