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

ConditionsPancreatic CancerCirculating Tumor CellPredictive Cancer Model
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-99
SponsorElisabethinen Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Informed consent

>18 years old

localized pancreatic cancer to go for upfront surgery

Disqualifiers

synchronous secondary malignancy

pregnancy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Neoadjuvant chemotherapy instead of upfront surgery

    Procedure/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

    Procedure/Surgery

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

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: ctDNA guidedExperimental treatment 1 intervention
Group B: Standard of careOther 1 intervention

Trial outcomes

Primary outcomes

1

DFS

Disease free survival

Time frame
After 12 months

Secondary outcomes

1

OS

Overall survival

Time frame
After 12 months
2

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

Time frame
Preoperatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Elisabethinen Hospital

Lead sponsor

Krankenhaus Barmherzige Schwestern Linz

Sponsor institution

Medical University Innsbruck

Collaborator

Source ClinicalTrials.gov
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