Additional Treatment for Isolated Local Pancreatic Cancer Recurrence Using Stereotactic Body Radiation Therapy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUMC Utrecht
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Additional stereotactic body radiation therapy
Radiation5 fractions of 8 Gray stereotactic body radiation therapy in addition to standard of care.
Treatment groups
174 Participants
are divided into 2 treatment groupsGroup A: Additional stereotactic body radiation therapyExperimental treatment 1 intervention
Group B: Standard of careNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Survival after recurrence
The interval between the date of PDAC recurrence diagnosis and either death from any cause or last follow-up.
Time frame
From the date of PDAC recurrence diagnosis until either death from any cause or last follow-u, whichever came first, assessed up to 24 monthsSecondary outcomes
1
Patient reported Quality of Life as assessed using Exocrine Pancreatic Insufficiency (EPI) questionnaire
Part of the Patient Reported Outcome Measures (PROMs) that are being standardly measured in PACAP-participants.
Time frame
At baseline and at 3, 6, 9, 12, 18 and 24 months and every subsequent year after enrollment in the PACAP-cohort. Assessed through study completion, up to 18 months2
Patient reported non-disease specific health-related Quality of Life (HRQoL) as assessed using the EQ-5D-5L
Part of the Patient Reported Outcome Measures (PROMs) that are being standardly measured in PACAP-participants.
Time frame
At baseline and at 3, 6, 9, 12, 18 and 24 months and every subsequent year after enrollment in the PACAP-cohort. Assessed through study completion, up to 18 months3
Patient reported cancer-specific HRQoL as assessed using the EORTC QLQ-C30
Part of the Patient Reported Outcome Measures (PROMs) that are being standardly measured in PACAP-participants.
Time frame
At baseline and at 3, 6, 9, 12, 18 and 24 months and every subsequent year after enrollment in the PACAP-cohort. Assessed through study completion, up to 18 months4
Patient reported tumor-specific HRQoL as assessed using the EORTC LQPAN26
Part of the Patient Reported Outcome Measures (PROMs) that are being standardly measured in PACAP-participants.
Time frame
At baseline and at 3, 6, 9, 12, 18 and 24 months and every subsequent year after enrollment in the PACAP-cohort. Assessed through study completion, up to 18 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
UMC Utrecht
Lead sponsor
Dutch Pancreatic Cancer Group (DPCG)
Collaborator
Source ClinicalTrials.gov