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

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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON55290

Enrollment

120

Registered

2021-02-18

Start date

2021-07-05

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pancreatic cancer pancreatic ductal adenocarcinoma

Interventions

Local ablative therapy (SBRT) in addition to standard of care, consisting of 5 times 8 Gy SBRT.

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: PACAP-participants with isolated local PDAC recurrence are eligible for randomization if they meet all of the following criteria: - Isolated local PDAC recurrence after primary resection; - ECOG performance score 0-2; - Written informed consent for being randomized in future studies.

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - Age

Design outcomes

Primary

Measure	Time frame
Primarily, the effect of SBRT in addition to standard of care compared to standard of care alone on survival after recurrence is investigated.	—

Secondary

Measure	Time frame
Secondary outcomes are: patient-reported quality of life, treatment response assessed by CT-imaging, acute and late toxicity, overall survival, progression-free survival, local progression-free survival, distant metastasis free survival.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)