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Additional Treatment for Isolated Local Pancreatic Cancer Recurrence Using Stereotactic Body Radiation Therapy

NCT04881487 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 174

Last updated 2026-05-05

No results posted yet for this study

Summary

A randomized controlled trial, nested within an existing prospective cohort (Dutch Pancreatic Cancer Project; PACAP) according to the 'trials within cohorts' (TwiCs) design in which the effect of additional local ablative therapy compared to current standard of care alone, on survival after recurrence in patients with isolated local pancreatic ductal adenocarcinoma (PDAC) recurrence. The most important secondary endpoint is quality of life. Other secondary endpoints are treatment response, acute and late toxicity, overall survival, progression-free survival, local progression-free survival, distant metastases free survival and reasons for non-eligibility or exclusion.

Conditions

  • Recurrent Pancreatic Ductal Adenocarcinoma

Interventions

RADIATION

Additional stereotactic body radiation therapy

5 fractions of 8 Gray stereotactic body radiation therapy in addition to standard of care.

Sponsors & Collaborators

  • Dutch Pancreatic Cancer Group (DPCG)

    collaborator UNKNOWN

  • UMC Utrecht

    lead OTHER

Principal Investigators

  • M. P.W. Intven, MD, PhD · Regional Academic Cancer Center Utrecht (RACU)

  • A. M.E. Bruynzeel, MD, PhD · Amsterdam University Medical Center, VUmc

  • J. Nuyttens, MD, PhD · Erasmus Medical Center

  • I. Q. Molenaar, MD, PhD · Regional Academic Cancer Center Utrecht (RACU)

  • M. G.H. Besselink, MD, PhD · Amsterdam University Medical Center, AMC

  • B. Groot Koerkamp, MD, PhD · Erasmus Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-05
Primary Completion
2026-08-31
Completion
2028-02-29

Countries

  • Netherlands

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 NCT04881487 on ClinicalTrials.gov