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

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.

Interventions

• Additional stereotactic body radiation therapy · RADIATION

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

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

Inclusion Criteria:

* 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

Exclusion Criteria:

* Distant metastases
* Expected lifespan \< 3 months
* Ineligibility for MRI or CT according to the protocol of the local radiology department;
* Highly selective cases with resectable, isolated local recurrence without the need for either systemic or local ablative induction therapy, eligible for re-resection according to the expert panel.

Sites (3)

• Amsterdam University Medical Center, VUmc, Amsterdam, North Holland, Netherlands · RECRUITING
• Erasmus University Medical Center, Rotterdam, South Holland, Netherlands · RECRUITING
• University Medical Center Utrecht, Utrecht, Utrecht, Netherlands · RECRUITING