Clinical trial · Observational
PEI REGIMEN: A Therapeutic Option in Small Cell Lung Cancer? A Monoinstitutional Experience of 46 Consecutive Cases
PEI REGIMEN: A THERAPEUTIC OPTION IN SMALL CELL LUNG CANCER? A MONOINSTITUTIONAL EXPERIENCE OF 46 CONSECUTIVE CASES
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Small Cell Lung Cancer | Lung Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ifosfamide | Drug | Ifosfamide | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- partial response (PR)
- timeFrame
- 1 year
- measure
- complete response (CR)
- timeFrame
- 1 YEAR
Secondary outcomes (2)
- measure
- Median time to progression (TTP)
- timeFrame
- 1 YEAR
- measure
- overall survival (OS)
- timeFrame
- 1 YEAR
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * histologically or cytologically proven SCLC * measurable disease defined by RECIST criteria Exclusion Criteria:
References
Publications (1)
- DERIVEDBoni C, Pagano M, Baldi L, Gnoni R, Braglia L, Savoldi L, Zanelli F. Pei regimen: a therapeutic option in small cell lung cancer? A retrospective monoinstitutional analysis of 46 consecutive cases. J Transl Med. 2015 Apr 24;13:130. doi: 10.1186/s12967-015-0491-3. PMID 25903963