Randomized Study of Cisplatin-Etoposide Versus an Etoposide Regimen Without Cisplatin in Extensive Small-Cell Lung Cancer

Condition(s) targeted: Small Cell Lung Carcinoma, Extensive Disease

Intervention: Cisplatin + etoposide (Drug); Epirubicin + ifosfamide + etoposide (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: European Lung Cancer Working Party

Official(s) and/or principal investigator(s):
Jean-Paul Sculier, MD, PhD, Study Chair, Affiliation: European Lung Cancer Working Party

Overall contact:
Nathalie Leclercq, RN, Phone: 32-2-539-0496, Email: nathalie.leclercq@bordet.be

The purpose of this study is to determine if a cisplatin-etoposide regimen improves survival in comparison to a regimen containing etoposide and without platinum derivative.

Official title: A Phase III Randomized Study Comparing A Chemotherapy With Cisplatin And Etoposide To A Etoposide Regimen Without Cisplatin For Patients With Extensive Small-Cell Lung Cancer

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Survival

Secondary outcome:

Response rate

Toxicity

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Histological or cytological diagnosis of small-cell lung cancer

- Extensive disease (i. e. a disease with distant metastases or that cannot be included

in a single irradiation field incorporating primary tumour, mediastinum and supraclavicular lymph node(s))

- Availability for participating in the detailed follow-up of the protocol

- Presence of an evaluable or measurable lesion

- Informed consent

Exclusion Criteria:

- Prior treatment with chemotherapy, radiotherapy or surgery

- Performance status < 60 on the Karnofsky scale

- A history of prior malignant tumor, except non-melanoma skin cancer or in situ

carcinoma of the cervix or a cured cancer (defined as a disease-free interval > 5 years)

- White blood cells < 4000/mm3

- Platelets < 100000/mm3

- Serum bilirubin > 1. 5 mg/100 ml

- Serum creatinine > 1. 3 mg/100 ml and creatinine clearance <60 ml/min

- Recent myocardial infarction (less than 3 months prior to date of diagnosis)

- Congestive cardiac failure or cardiac arrhythmia uncontrolled by medical treatment

- Uncontrolled infectious disease

- Serious medical or psychological factors which may prevent adherence to the treatment

schedule

Nathalie Leclercq, RN, Phone: 32-2-539-0496, Email: nathalie.leclercq@bordet.be

Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet, Brussels 1000, Belgium; Recruiting
Jean-Paul Sculier, MD, PhD, Principal Investigator

Department of Pneumology CHRU Lille, Lille, France; Recruiting
Arnaud Scherpereel, MD, PhD, Phone: 33-32-044-4998
Arnaud Scherpereel, MD, PhD, Principal Investigator

Hellenic Cancer Institute - St Savas Oncology Hospital, Athens, Greece; Recruiting
Anna Efremidis, MD, Principal Investigator

Medical Oncology Hospital de Sagunto, Valencia, Spain; Recruiting
Vicente Giner, MD, Principal Investigator

Click here for more information on the protocol

Trials registry of the French National Cancer Institute

Starting date: April 2000
Last updated: January 28, 2013