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PAXG Out in the Country

NCT04480268 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 175

Last updated 2021-02-10

No results posted yet for this study

Summary

The objective of this study is to assess the reproducibility of PAXG regimen as first-line/primary chemotherapy in daily clinical practice in Pancreatic Ductal Adenocarcinoma (PDAC) borderline resectable, locally advanced or metastatic patients out of a large volume center.

Conditions

Interventions

DRUG

PAXG regimen (cisplatin, nab-paclitaxel, capecitabine, gemcitabine) chemotherapy

The PAXG regimen includes: * nab-paclitaxel 150 mg/m2 on day 1 and 15 of each cycle; * cisplatin 30 mg/m2 on day 1 and 15 of each cycle; * capecitabine 1250 mg/m2 on 1 day to 28 of each cycle; * gemcitabine 800 mg/m2 on day 1 and 15 of each cycle. Each cycle lasts 28 days. Patients are treated until maximal response, disease progression or unacceptable toxicity.

Sponsors & Collaborators

  • IRCCS San Raffaele

    lead OTHER

Principal Investigators

  • Michele Reni, MD · IRCCS Ospedale San Raffaele

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2020-07-08
Primary Completion
2022-01-01
Completion
2026-01-01

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

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 NCT04480268 on ClinicalTrials.gov