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RECRUITING
NCT06391892
PHASE3

Liquid Biopsy (ctDNA) Guided Treatment in Localized Pancreatic Cancer: Neoadjuvant CTX vs. Upfront Surgery

Sponsor: Elisabethinen Hospital

View on ClinicalTrials.gov

Summary

This study evaluates the clinical prognostic impact (on DFS and OS) of liquid biopsy guided treatment vs. standard of care (physicians choice) in localized pancreatic cancer (despite because of CA 19-9 levels and computed tomography, upfront surgery is recommended by tumor board). ctDNA positive patients will receive neoadjvuant chemotherapy at current gold standard physicians choice instead of upfront surgery, because of assumed high biological risk for early recurrence.

Official title: Liquid Biopsy Guided Treatment in Localized Pancreatic Cancer (LIQUIPANC): Circulating Tumor DNA (ctDNA) as Precision Medicine Tool for Stratification of Neoadjuvant Chemotherapy vs. Upfront Surgery

Key Details

Gender

All

Age Range

18 Years - 99 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2024-01-11

Completion Date

2026-12-31

Last Updated

2024-04-30

Healthy Volunteers

No

Interventions

PROCEDURE

Neoadjuvant chemotherapy instead of upfront surgery

All patients included into the study are recommended to go for upfront surgery (CT and CA19-9) by tumor board. If preoperative ctDNA is positive, the investigators assume high risk for early recurrence (because of systemic tumor burden) and apply neoadjuvant chemotherapy at physicians choice instead. * Apart from blood collection (within the scope of clinical routine), there is no additional diagnostic intervention performed on the patient. * The respective neoadjuvant chemotherapeutical drug will be selected and applied by the treating medical oncologist at physicians choice (unaffected by study participation), usually mFOLFIRINOX or Gemcitabine/nabPaclitaxel at standardized dosage recommended by NCCN and local guidelines. FOLFIRONOX: Folinic acid (also known as leucovorin), F - Fluorouracil (5-FU), IRIN - Irinotecan, OX - Oxaliplatin.

PROCEDURE

Upfront surgery

Standard of care as recommended by tumor board (not affected by study conditions).

Locations (1)

Ordensklinikum Linz Barmherzige Schwestern

Linz, Upper Austria, Austria