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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00658580
• Date of registration: 11/04/2008
• Prospective Registration: No
• Primary sponsor: European Lung Cancer Working Party
• Public title: Randomized Study of Cisplatin-Etoposide Versus an Etoposide Regimen Without Cisplatin in Extensive Small-Cell Lung Cancer
• Scientific 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
• Date of first enrolment: April 2000
• Target sample size: 361
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00658580
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Belgium, France, Greece, Spain

Contacts

• Name: Jean-Paul Sculier, MD, PhD
• Affiliation: European Lung Cancer Working Party

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Small Cell Lung Carcinoma, Extensive Disease

Intervention(s)

Drug: Epirubicin + ifosfamide + etoposide

Drug: Cisplatin + etoposide

Primary Outcome(s)

Survival [Time Frame: Survival will be dated from the day of randomisation until death or last follow up]

Secondary Outcome(s)

Response rate [Time Frame: Every 3 cycles of chemotherapy]

Toxicity [Time Frame: After every cycle of chemotherapy]

Secondary ID(s)

ELCWP 01994

Source(s) of Monetary Support

Please refer to primary and secondary sponsors