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A Randomized Controlled Trial on Additional Treatment for Isolated Local Pancreatic Cancer Recurrence Using Stereotactic Body Radiation Therapy

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Participation in the PACAP cohort with written informed consent for being randomized in future studies

• Isolated local recurrence after primary PDAC resection

• Minimum age of 18 years

Locations
Other Locations
Netherlands
Amsterdam University Medical Center, VUmc
RECRUITING
Amsterdam
Erasmus University Medical Center
RECRUITING
Rotterdam
University Medical Center Utrecht
RECRUITING
Utrecht
Contact Information
Primary
M. P.W. Intven, MD PhD
m.intven@umcutrecht.nl
0630866525
Time Frame
Start Date: 2021-07-05
Estimated Completion Date: 2028-02
Participants
Target number of participants: 174
Treatments
Experimental: Additional stereotactic body radiation therapy
SBRT in addition to standard of care.
No_intervention: Standard of care
Treatment according to current clinical practice.
Related Therapeutic Areas
Sponsors
Collaborators: Dutch Pancreatic Cancer Group (DPCG)
Leads: UMC Utrecht

This content was sourced from clinicaltrials.gov