Clinical trial NCT00658580: Randomized Study of Cisplatin-Etoposide Versus an Etoposide Regimen Without Cisplatin in Extensive Small-Cell Lung Cancer
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Small Cell Lung Carcinoma, Extensive Disease
Keywords: Small cell lung carcinoma
Chemotherapy
Phase III randomised study
Lead sponsor: European Lung Cancer Working Party
Sponsor class: OTHER
First posted: 2008-04-15
Enrollment: 361
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Survival
timeFrame: Survival will be dated from the day of randomisation until death or last follow up
Secondary outcomes:
measure: Response rate
timeFrame: Every 3 cycles of chemotherapy
measure: Toxicity
timeFrame: After every cycle of chemotherapy
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet
city: Lille
country: France
facility: Department of Pneumology CHRU Lille
city: Athens
country: Greece
facility: Hellenic Cancer Institute - St Savas Oncology Hospital
city: Valencia
country: Spain
facility: Medical Oncology Hospital de Sagunto
Study officials:
affiliation: European Lung Cancer Working Party
name: Jean-Paul Sculier, MD, PhD
role: STUDY_CHAIR
References:
citation: Berghmans T, Scherpereel A, Meert AP, Giner V, Lecomte J, Lafitte JJ, Leclercq N, Paesmans M, Sculier JP; European Lung Cancer Working Party (ELCWP). 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. Front Oncol. 2017 Sep 19;7:217. doi: 10.3389/fonc.2017.00217. eCollection 2017.