RecruitingPhase 2Phase 3NCT06037980

CisPlatin plUs Gemcitabine and Nabpaclitaxel (GAP) as pReoperative Chemotherapy Versus Immediate Resection in patIents With resecTable BiliarY Tract Cancers (BTC) at High Risk for Recurrence

A Phase II/III Randomized Clinical Trial of CisPlatin plUs Gemcitabine and Nabpaclitaxel (GAP) as pReoperative Chemotherapy Versus Immediate Resection in patIents With resecTable BiliarY Tract Cancers (BTC) at High Risk for Recurrence: PURITY Study


Sponsor

Gruppo Oncologico del Nord-Ovest

Enrollment

300 participants

Start Date

Nov 7, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

PURITY is a multicentre, randomized adaptive phase II/III trial aimed at comparing the triplet combination of gemcitabine, cisplatin and nabpaclitaxel as neoadjuvant treatment (ARM A) versus standard upfront surgery (ARM B) in terms of 12-month PFS rate (phase II part) and PFS (phase III part) in patients with resectable BTC at high risk for recurrence.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two approaches for treating bile duct and gallbladder cancers that can be surgically removed: giving chemotherapy before surgery (to shrink the tumor first) versus going directly to surgery. The chemotherapy regimen being tested is a combination of cisplatin, gemcitabine, and nab-paclitaxel. **You may be eligible if...** - You are 18–74 years old - You have confirmed bile duct cancer (cholangiocarcinoma) or gallbladder cancer that has not spread to other organs and can be surgically removed - You have not had prior surgery for this cancer - Scans confirm no distant spread of disease - You are in generally good health (ECOG status 0–1) **You may NOT be eligible if...** - Your cancer has spread to distant organs - You have mixed tumor types involving liver cancer or ampullary cancer - You have had previous treatment for bile duct or gallbladder cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGemcitabine

◦ Gemcitabine 800 mg/mq iv, day 1 and 8 of 21-day cycles, for 3 cycles

DRUGNab paclitaxel

◦ Nab-paclitaxel 100 mg/mq, day 1 and 8 of 21-day cycles, for 3 cycles

DRUGCisplatin

◦ Cisplatin 25 mg/mq iv, day 1 and 8 of 21-day cycles, for 3 cycles

PROCEDURECurative Surgery

Curative surgery on primary tumor

DRUGCapecitabine

1250 mg/m2 given orally twice daily on days 1 to 14 of a 3 weekly cycle for a total of 8 cycles


Locations(19)

Ospedali Riuniti di Ancona

Ancona, Italy

ASST Papa Giovanni XXIII

Bergamo, Italy

Oncologia Medica Policlinico Sant'Orsola - Malpighi

Bologna, Italy

ASST Spedali Civili

Brescia, Italy

Azienda Ospedaliera S. Croce e Carle

Cuneo, Italy

IRST Dino Amadori

Meldola, Italy

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Italy

Humanitas Cancer Center

Milan, Italy

Ospedale Niguarda Cancer Center

Milan, Italy

Ospedale San Raffaele

Milan, Italy

Università di Modena

Modena, Italy

Ospedale S. Gerardo

Monza, Italy

IOV

Padova, Italy

Policlinico San Matteo

Pavia, Italy

Azienda Ospedaliera Universitaria Pisa

Pisa, Italy

IRST (Cesena-Forlì-Meldola)

Ravenna, Italy

Policlinico Gemelli

Rome, Italy

Azienda Ospedaliera Ordine Mauriziano

Turin, Italy

AOUI Verona - Policlinico "G.B. Rossi"

Verona, Italy

View Full Details on ClinicalTrials.gov

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NCT06037980


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