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PEI REGIMEN: A Therapeutic Option in Small Cell Lung Cancer? A Monoinstitutional Experience of 46 Consecutive Cases

NCT02324296 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 46

Last updated 2025-06-11

No results posted yet for this study

Summary

ABSTRACT Objectives Combination chemotherapy is very active in small cell lung cancer (SCLC), although no improvement in overall survival (OS) has been done in the last 25 years , with Cisplatin-Etoposide (PE) still considered the world-wide standard, with an average median survival of about 7-8 months in patients with extended disease (ED).

In 1995, a randomized trial of the Hoosier Group in 171 ED patients showed a significant advantage in overall survival in patients treated with PEI (Cisplatin, Etoposide and Ifosfamide), compared to PE. Despite that, PEI regimen has not become a commonly used regimen in SCLC.

Materials and Methods Here we present a series of 46 consecutive patients (30 males and 16 females) with SCLC that were treated at our Institution with PEI regimen: Cisplatin 20mg/m2, Etoposide 75mg/m2 and Ifosfamide 1200mg/m2, day 1 to 4, every 3 weeks.

Patients received a total of 219 cycles of chemotherapy, with a mean of 4,7 cycles per patient. Median age was 63 (range 59-70); performance status (PS) was 0 in 29 patients (63%), 1 in 13 patients (28%) and 2 in 4 patients (9%).

Conditions

Interventions

DRUG

ifosfamide

PEI regimen may be a possible therapeutic option, with high activity and an acceptable toxicity profile.

Sponsors & Collaborators

  • Azienda USL Reggio Emilia - IRCCS

    lead OTHER_GOV

Eligibility

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

Timeline & Regulatory

Start
1998-12-31
Primary Completion
2009-01-31
Completion
2010-12-31

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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 NCT02324296 on ClinicalTrials.gov