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Stereotactic PAncreatic RadioTherapy Adjuvant Therapy

NCT05043857 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-04-30

No results posted yet for this study

Summary

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.

Conditions

  • Pancreas Cancer

Interventions

RADIATION

Stereotactic Body Radiotherapy (SBRT)

Postoperative Stereotactic Body Radiation Therapy (SBRT) after tumor resection targeting 2 volumes * CTV1 (clips+isotropic 5mm expansion, edited on anatomic barriers): receiving 40 Gy in 5 fractions of 8 Gy * CTV2 (CTV1+ anisotropic 10-15 mm expansion including corresponding vessels, retroperitoneum posterior to the SMV/SMA or celiac axis, edited on anatomic barriers): receiving 30 Gy in 5 fractions of 6 Gy.

Sponsors & Collaborators

  • Varian Medical Systems

    collaborator INDUSTRY

  • Istituto Clinico Humanitas

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-06
Primary Completion
2026-05-31
Completion
2026-05-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05043857 on ClinicalTrials.gov