Trial results for a study investigating Stereotactic Body Radiation Therapy (SBRT) in patients with intact Pancreatic Cancer were posted on 2025-07-18. The Phase 1/2 study, which enrolled 15 participants, determined a maximum tolerated dose of 45 Gy.
Background
Pancreatic cancer is an aggressive malignancy with a generally poor prognosis, often diagnosed at advanced stages. Treatment options typically include surgery, chemotherapy, and conventional radiation therapy, but outcomes remain challenging. Stereotactic Body Radiation Therapy (SBRT) is a highly precise form of radiation that delivers high doses to a tumor while minimizing exposure to surrounding healthy tissues. This approach aims to improve local control and potentially reduce treatment-related side effects, making the investigation into its optimal dosing and safety profile crucial for patients with intact pancreatic cancer.
Trial design
This completed Phase 1/Phase 2 study enrolled 15 participants with Pancreatic Cancer. The trial's primary objective was to determine the highest tolerated dose of Stereotactic Body Radiation Therapy (SBRT) and identify an appropriate dose for intact pancreatic cancer. The study evaluated different dose levels of SBRT to assess safety and preliminary efficacy.
Key results
The study identified the following key measurements:
- Maximum Tolerated Dose (Phase 1): The maximum tolerated dose for Stereotactic Radiation was determined to be 45 Gy.
- The Number of Patients With Late (>28 Days) Grade 3+ GI Toxicity:
- In the Stereotactic Radiation: 10 Gy x3 group, 2 participants experienced late Grade 3+ GI toxicity.
- In the Stereotactic Radiation: 12.5 Gy x3 group, 0 participants experienced late Grade 3+ GI toxicity.
- In the Stereotactic Radiation: 15 Gy x3 group, 2 participants experienced late Grade 3+ GI toxicity.
- Number of Participants With an Improvement in Patient Reported Pain Score Using Visual Analog Scale:
- In the Stereotactic Radiation: 10 Gy x3 group, 3 Participants showed an improvement in pain score.
- In the Stereotactic Radiation: 12.5 Gy x3 group, 0 Participants showed an improvement in pain score.
- In the Stereotactic Radiation: 15 Gy x3 group, 2 Participants showed an improvement in pain score.
- Number of Patients Eligible for Surgery to Remove Tumor After Treatment:
- In the Stereotactic Radiation: 10 Gy x3 group, 0 participants were eligible for surgery.
- In the Stereotactic Radiation: 12.5 Gy x3 group, 0 participants were eligible for surgery.
- In the Stereotactic Radiation: 15 Gy x3 group, 0 participants were eligible for surgery.
- Number of Patients With Local Disease Control:
- In the Stereotactic Radiation: 10 Gy x3 group, 3 participants achieved local disease control.
- In the Stereotactic Radiation: 12.5 Gy x3 group, 3 participants achieved local disease control.
What this means
The determination of a maximum tolerated dose of 45 Gy for SBRT in intact pancreatic cancer provides crucial information for future clinical trials and treatment planning. The observed late Grade 3+ gastrointestinal toxicity varied across dose groups, with 0 participants experiencing this toxicity in the 12.5 Gy x3 group, compared to 2 participants in both the 10 Gy x3 and 15 Gy x3 groups. While some participants reported pain improvement (3 participants in 10 Gy x3 and 2 participants in 15 Gy x3), no participants across any dose group became eligible for surgical tumor removal after SBRT. Local disease control was achieved in 3 participants in both the 10 Gy x3 and 12.5 Gy x3 groups, suggesting potential efficacy in controlling local tumor growth at these dose levels.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT01342354, titled "Study of Stereotactic Body Radiation Therapy in Patients With Intact Pancreatic Cancer", were posted on 2025-07-18 on clinicaltrials.gov.