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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06391892
Other study ID # 1199/2023
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date January 11, 2024
Est. completion date December 31, 2026

Study information

Verified date April 2024
Source Elisabethinen Hospital
Contact Patrick Kirchweger, MD, PhD
Phone +436644159646
Email patrick.kirchweger@ordensklinikum.at
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Pancreatic cancer (PC) bears dramatically high relapse rates with consecutive low 5-year survival rates (4.2% over all tumor stages and 0.5% in stage IV disease) despite major improvements of interdisciplinary perioperative management and more aggressive surgical approaches to enable potentially curative pancreatic surgery. PC is estimated to represent the second most cancer associated cause of death by 2030 worldwide. Circulating tumor DNA (ctDNA) has been outpointed to be a promising prognostic marker for several malignant diseases. In precursor studies, the investigators have shown (a) a definitive cut-off (42% decrease from the baseline) for the relative change of ctDNA after only 2 weeks of systemic chemotherapy to reliably (specificity 100%, sensitivity 91.7%) predict response to treatment at a median of 10 weeks earlier (80% faster) than current gold standard (computed tomography after 3 months of treatment) via simple blood collection and consecutive molecular analysis via ddPCR (Kirchweger et al., Frontiers in Oncology, 08/22), which could allow an early change of treatment regimen in the future in order to improve patients survival and decrease the amount of unevaluated cytotoxic agents. Furthermore, the investigators could show (b) that pretherapeutic detectable ctDNA in localized PC could reliably indicate early distant relapse (DFS 3.3 vs. 18.1 months) despite no radiological evidence of advanced or disseminated disease prior to surgery (Kirchweger et al., European Journal of Surgical Oncology, 12/21). All patients in this study suffering from early relapse went through interdisciplinary tumor boards and did not receive neoadjuvant chemotherapy because of radiological resectability and CA 19-9 values within the normal range (<500kU/l). ctDNA on the other hand bears the potential to differentiate localized from disseminated disease. The planned project aims to prove a clinical applicable easily assessable and minimal invasive approach (mere blood collection during clinical routine) of molecular testing in the periphery to distinguish localized from disseminated disease in pancreatic cancer patients to highly individually stratify for neoadjuvant chemotherapy or upfront surgery on a (molecular)-biological base with a high sensitive method to oppose current difficulties of detection rates in PC in addition to current gold standard of radiological staging in the future. The investigators will take approximately 30ml of blood (simple blood puncture) from patients with localized pancreatic cancer who have undergone full staging procedure and have been recommended upfront surgery by interdisciplinary tumor board. ddPCR will be performed by testing KRAS G12/13 and, if negative, KRAS Q61 preoperatively. ctDNA positive patients will be distributed to either observation group (standard of care - upfront surgery) or personalized treatment group (LB informed treatment decisions - neoadjuvant/adjuvant chemotherapy). Treatment groups will be compared for PFS and OS.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 31, 2026
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria: - Informed consent - >18 years old - localized pancreatic cancer to go for upfront surgery Exclusion Criteria: - synchronous secondary malignancy - pregnancy

Study Design


Intervention

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

Locations

Country Name City State
Austria Ordensklinikum Linz Barmherzige Schwestern Linz Upper Austria

Sponsors (2)

Lead Sponsor Collaborator
Elisabethinen Hospital Medical University Innsbruck

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary DFS Disease free survival After 12 months
Secondary OS Overall survival After 12 months
Secondary ctDNA detection rate Detection rate of ctDNA in peripheral blood using a cost-effective and clinical applicable small spectrum ddPCR analysis in order to enable immediate clinical implementation Preoperatively
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