NCT00658580CompletedPhase 3
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
European Lung Cancer Working Party4 sites in 4 countries361 target enrollmentStarted: April 2000Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 361
- Locations
- 4
- Primary Endpoint
- Survival
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
A
Active Comparator
Every 3 weeks intravenous cisplatin plus etoposide
Intervention: Cisplatin + etoposide (Drug)
B
Experimental
Every 3 weeks intravenous epirubicin plus ifosfamide plus etoposide
Intervention: Epirubicin + ifosfamide + etoposide (Drug)
Outcomes
Primary Outcomes
Survival
Time Frame: Survival will be dated from the day of randomisation until death or last follow up
Secondary Outcomes
- Response rate(Every 3 cycles of chemotherapy)
- Toxicity(After every cycle of chemotherapy)
Investigators
Study Sites (4)
Loading locations...
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