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Short-course Versus Long-course Pre-operative Chemotherapy With mFOLFIRINOX or PAXG (CASSANDRA TRIAL)

NCT04793932 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 261

Last updated 2025-04-09

No results posted yet for this study

Summary

The main aim of this study is to compare the efficacy of short-course versus long-course pre-operative chemotherapy with PAXG or mFOLFIRINOX in patients who receive a diagnosis of pancreatic ductal adenocarcinoma (PDAC) resectable or borderline resectable.

Conditions

  • Pancreas Ductal Adenocarcinoma

Interventions

DRUG

PAXG

Nab-paclitaxel, cisplatin and gemcitabine drugs will be administered on day 1 and 15 every 28 days. Capecitabine tablets will be taken orally on days 1 to 28, every 28 days

DRUG

mFOLFIRINOX

Oxaliplatin, folinic acid, irinotecan and 5-Fluoruracil will be administered on day 1 and 15 every 28 days

DRUG

short-course chemotherapy

other two months of chemotherapy after surgery

DRUG

long-course chemotherapy

other two months of chemotherapy before surgery

Sponsors & Collaborators

  • High Research srl

    collaborator UNKNOWN

  • Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente

    collaborator OTHER

  • Associazione Italiana per lo Studio del Pancreas

    lead OTHER

Principal Investigators

  • Michele Reni, MD · IRCCS San Raffaele

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-03
Primary Completion
2025-03-15
Completion
2026-01-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04793932 on ClinicalTrials.gov