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

NCT04881487 | Recruiting

• 3 other identifiers: NL74336.041.2020-80512568
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

Stereotactic body radiation therapy

Outcome Measures

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.

  From the date of PDAC recurrence diagnosis until either death from any cause or last follow-u, whichever came first, assessed up to 24 months

Secondary Outcomes (14)

• Patient reported Quality of Life as assessed using Exocrine Pancreatic Insufficiency (EPI) questionnaire

  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 months

• Patient reported non-disease specific health-related Quality of Life (HRQoL) as assessed using the EQ-5D-5L

  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 months

• Patient reported cancer-specific HRQoL as assessed using the EORTC QLQ-C30

  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 months

• Patient reported tumor-specific HRQoL as assessed using the EORTC LQPAN26

  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 months

• Patient reported chemotherapy-induced peripheral neuropathy as assessed using the EORTC QLQ-CIPN20

  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 months

Study Arms (2)

Additional stereotactic body radiation therapy

EXPERIMENTAL

SBRT in addition to standard of care.

Radiation: Additional stereotactic body radiation therapy

Standard of care

NO INTERVENTION

Treatment according to current clinical practice.

Interventions

Additional stereotactic body radiation therapy RADIATION

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

Additional stereotactic body radiation therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• UMC Utrecht: lead
• Dutch Pancreatic Cancer Group (DPCG): collaborator

Study Sites (3)

Amsterdam University Medical Center, VUmc

Amsterdam, North Holland, 1081 HV, Netherlands

RECRUITING

Erasmus University Medical Center

Rotterdam, South Holland, 3015 GD, Netherlands

RECRUITING

University Medical Center Utrecht

Utrecht, Utrecht, 3584 CX, Netherlands

RECRUITING

Related Publications (1)

• van Goor IWJM, Daamen LA, Besselink MG, Bruynzeel AME, Busch OR, Cirkel GA, Groot Koerkamp B, Haj Mohammed N, Heerkens HD, van Laarhoven HWM, Meijer GJ, Nuyttens J, van Santvoort HC, van Tienhoven G, Verkooijen HM, Wilmink JW, Molenaar IQ, Intven MPW; Dutch Pancreatic Cancer Group. A nationwide randomized controlled trial on additional treatment for isolated local pancreatic cancer recurrence using stereotactic body radiation therapy (ARCADE). Trials. 2022 Oct 28;23(1):913. doi: 10.1186/s13063-022-06829-1.

  PMID: 36307892 DERIVED

Study Officials

• M. P.W. Intven, MD, PhD

  Regional Academic Cancer Center Utrecht (RACU)

  PRINCIPAL INVESTIGATOR

• A. M.E. Bruynzeel, MD, PhD

  Amsterdam University Medical Center, VUmc

  PRINCIPAL INVESTIGATOR

• J. Nuyttens, MD, PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

• I. Q. Molenaar, MD, PhD

  Regional Academic Cancer Center Utrecht (RACU)

  PRINCIPAL INVESTIGATOR

• M. G.H. Besselink, MD, PhD

  Amsterdam University Medical Center, AMC

  PRINCIPAL INVESTIGATOR

• B. Groot Koerkamp, MD, PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

M. P.W. Intven, MD PhD

CONTACT

0630866525; m.intven@umcutrecht.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Trials within Cohorts (TwiCs)

Study Record Dates

• First Submitted: March 25, 2021
• First Posted: May 11, 2021
• Study Start: July 5, 2021
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): February 1, 2028
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Access Criteria: Upon request.

Locations

NL (3)