An open labelled phase III adjuvant trial of disease-free survival in patients with resected pancreatic ductal adenocarcinoma randomized to allocation of oxaliplatin- or gemcitabine-based chemotherapy by standard clinical criteria or by a transcriptomic treatment specific stratification signature (ESPAC-6)

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-514682-19-00

Acronym

ESPAC-6

Enrollment

394

Registered

2024-11-06

Start date

Unknown

Completion date

Unknown

Last updated

2025-12-16

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

Conditions

Resected pancreatic ductal adenocarcinoma

Brief summary

Disease free survival, time from randomization to disease recurrence or death from any cause

Detailed description

Overall survival., Metastasis free survival., Overall survival from recurrence., Quality of life (EORTC QLQ C-30)., Assessment of safety: i. Grade 3 and 4 toxicities according to NCI-CTC v.5.0. ii. Adverse and serious adverse events.

Interventions

DRUGFLUOROURACIL

DRUGOXALIPLATIN

DRUGIRINOTECAN

DRUGGEMCITABINE

DRUGCAPECITABINE

DRUGCALCIUM FOLINATE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Disease free survival, time from randomization to disease recurrence or death from any cause	—

Secondary

Measure	Time frame
Overall survival., Metastasis free survival., Overall survival from recurrence., Quality of life (EORTC QLQ C-30)., Assessment of safety: i. Grade 3 and 4 toxicities according to NCI-CTC v.5.0. ii. Adverse and serious adverse events.	—

Countries

Germany, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026