LAPSTAR Trial
The LAPSTAR trial (Locally Advanced Pancreatic Cancer After Systemic Therapy: Ablative MR-guided Radiotherapy) is a randomized controlled trial aimed at improving survival and quality of life for patients with locally advanced pancreatic cancer (LAPC). This trial investigates the addition of ablative MRI-guided radiotherapy (MRgRT) to standard chemotherapy treatment.
PI’s: Lois Daamen, Anna Bruynzeel, Martijn Intven
Background
Pancreatic cancer is among the most lethal cancer types, with a 10-year survival rate of only 4%. Approximately 40% of patients are diagnosed with LAPC, where tumors involve surrounding blood vessels, making surgical removal complex. Standard treatment involves chemotherapy to inhibit disease progression; however, the average survival remains around 15 months. Traditional radiotherapy has been challenging due to difficulties in visualizing pancreatic tumors and significant movement in the upper abdomen. MRI-guided radiotherapy addresses these challenges by providing high-precision imaging, allowing for targeted treatment even amidst organ motion.
Study Design
The LAPSTAR trial is a multicenter collaboration involving specialized radiation oncologists from UMC Utrecht, Amsterdam UMC, Radboud UMC, and Catharina Hospital, along with the Dutch Pancreatic Cancer Group and the Centre for Human Drug Research. The study evaluates the efficacy of adding ablative MRgRT (5 sessions of 10 Gy each) to standard chemotherapy in patients with LAPC. The primary outcome is health-related quality of life deterioration-free survival, measured from the time of randomization. Secondary outcomes include overall survival, tumor response, and the feasibility of home monitoring devices for patient follow-up.
Objectives
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Primary Objective: Assess whether the addition of ablative MRgRT to standard chemotherapy improves health-related quality of life deterioration-free survival in LAPC patients.
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Secondary Objectives:
- Evaluate overall survival.
- Assess the need for palliative interventions and subsequent treatments.
- Analyze the cost-effectiveness of the combined treatment approach.
- Explore the feasibility and effectiveness of home monitoring devices in patient follow-up.
Recent Developments
In May 2023, UMC Utrecht announced the initiation of the LAPSTAR trial, highlighting its potential to significantly impact the global treatment of locally advanced pancreatic cancer. The trial is currently recruiting participants, with ethical approval obtained and funding provided by the Dutch Cancer Society (KWF).
Related Research
- Daamen LA, Parikh PJ, Hall WA. The Use of MR-Guided Radiation Therapy for Pancreatic Cancer. Semin Radiat Oncol. 2024;34(1):23-35.
- Eijkelenkamp H, Grimbergen G, Daamen LA, et al. Clinical outcomes after online adaptive MR-guided stereotactic body radiotherapy for pancreatic tumors on a 1.5 T MR-linac. Front Oncol. 2023;13:1040673. Published 2023 Oct 3.
- Daamen LA, de Mol van Otterloo SR, van Goor IWJM, et al. Online adaptive MR-guided stereotactic radiotherapy for unresectable malignancies in the upper abdomen using a 1.5T MR-linac. Acta Oncol. 2022;61(1):111-115.
- Hall WA, Small C, Paulson E, et al. Magnetic Resonance Guided Radiation Therapy for Pancreatic Adenocarcinoma, Advantages, Challenges, Current Approaches, and Future Directions. Front Oncol. 2021;11:628155. Published 2021 May 11.
News and Updates
For more information and updates on the trial, visit ClinicalTrials.gov or New cancer research with MR-Linac and ultrasound. UMC Utrecht News. May 24, 2023.
People
Lois Daamen
Martijn Intven
Guus Grimbergen
