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

NCT06391892 | Recruiting Phase 3

• 1 other identifier: 1199/2023
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pancreatic Cancer; Circulating Tumor Cell; Predictive Cancer Model

Outcome Measures

Primary Outcomes (1)

• DFS

  Disease free survival

  After 12 months

Secondary Outcomes (2)

• OS

  After 12 months

• ctDNA detection rate

  Preoperatively

Study Arms (2)

ctDNA guided

EXPERIMENTAL

All patients included into the study are recommended to go for upfront surgery (localized and resectable tumor in CT and CA19-9 \<500kU/l) by tumor board. If preoperative ctDNA in peripheral blood is positive, we assume high risk for early recurrence (because of systemic tumor burden) and apply neoadjuvant chemotherapy at physicians choice instead.

Procedure: Neoadjuvant chemotherapy instead of upfront surgery

Standard of care

OTHER

Patient get the gold standard treatment at physicians choice, independent to study participation (here the study is just observational).

Procedure: Upfront surgery

Interventions

Neoadjuvant chemotherapy instead of upfront surgery PROCEDURE

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.

Also known as: Experimental

ctDNA guided

Upfront surgery PROCEDURE

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

Also known as: Standard of care

Standard of care

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent
• \>18 years old
• localized pancreatic cancer to go for upfront surgery

You may not qualify if:

• synchronous secondary malignancy
• pregnancy

Sponsors & Collaborators

• Elisabethinen Hospital: lead
• Medical University Innsbruck: collaborator

Study Sites (1)

Ordensklinikum Linz Barmherzige Schwestern

Linz, Upper Austria, 4010, Austria

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms; Neoplastic Cells, Circulating

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Patrick Kirchweger, MD, PhD

  Ordensklinikum Linz, Department of Surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick Kirchweger, MD, PhD

CONTACT

+436644159646; patrick.kirchweger@ordensklinikum.at

Helwig Wundsam, PD, MD

CONTACT

+4373276774562; helwig.wundsam@ordensklinikum.at

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Neoadjuvant chemotherapy (physicians choice) vs. upfront surgery

Study Record Dates

• First Submitted: April 20, 2024
• First Posted: April 30, 2024
• Study Start: January 11, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 30, 2024

Record last verified: 2024-04

Locations

AU (1)