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Stereotactic PAncreatic RadioTherapy Adjuvant Therapy

Study acronym: SPARTA
StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record status
This record was last updated April 30, 2026 (before its estimated May 31, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Primary and study completion dates: Jul 2025 to May 31, 2026v5
  2. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    • Collaborators expanded, about 3 words
    v4
  3. Study arms: 0 to 1v3
  4. Primary endpoint revised
    • Secondary endpoints: 1 to 2
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
While surgery is considered the only potentially curative therapy for pancreatic cancer, 5-year overall survival (OS) is typically \<25%. Following surgical resection of pancreatic cancer, adjuvant conventionally fractionated RT (CRT, delivering 45-54 Gy in 1.8-2.0 Gy per fraction) with 5-FU chemotherapy is recommended in high-risk patients (positive lymph nodes and/or R1-R2 resection margin status). However, the benefit of CRT in this setting is controversial due to lack of prospective positive data. Moreover, duration of treatment course (delaying initiation of more effective chemotherapy schedules), insufficient dose delivery due potential radiation-related severe toxicity to proximity organs represents a serious limitation to treatment efficacy. Stereotactic Body Radiotherapy (SBRT) is a novel radiotherapy technique consisting of highly focused irradiation with a steep dose gradient, thus allowing the delivery of ablative radiation doses and significant sparing of proximity critical structures. Higher doses per fraction allows for more intensive treatments and shorter duration of the radiation course.
Trial Details
NCT Number NCT05043857
Lead Sponsor Istituto Clinico Humanitas
Collaborators: Varian Medical Systems
Conditions
(from sponsor)		 Pancreas Cancer
Related terms Pancreatic Neoplasms
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov