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OpenTrials
Completed

NCT Number: NCT02324296

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

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%).

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • histologically or cytologically proven SCLC
  • measurable disease defined by RECIST criteria

Exclusion criteria

Treatment and study plan

ifosfamide

Drug

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

Other names: cisplatin, etoposide

Primary outcomes

  1. partial response (PR)

    Time frame: 1 year

  2. complete response (CR)

    Time frame: 1 YEAR

Secondary outcomes

  1. Median time to progression (TTP)

    Time frame: 1 YEAR

  2. overall survival (OS)

    Time frame: 1 YEAR

Sponsors and collaborators

Lead sponsor

Azienda USL Reggio Emilia - IRCCS

Other Gov

Registry information

Important dates

Study start
1998
Primary completion
2009
Study completion
2010
First posted
Dec 24, 2014
Registry last updated
Jun 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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