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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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Small Cell Lung Carcinoma, Extensive Disease

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Survival

Outcome Time Frame:

Survival will be dated from the day of randomisation until death or last follow up

Safety Issue:

Yes

Principal Investigator

Jean-Paul Sculier, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

European Lung Cancer Working Party

Authority:

Belgium: Federal Agency for Medicinal Products and Health Products

Study ID:

ELCWP 01994

NCT ID:

NCT00658580

Start Date:

April 2000

Completion Date:

June 2014

Related Keywords:

  • Small Cell Lung Carcinoma, Extensive Disease
  • Small cell lung carcinoma
  • Chemotherapy
  • Phase III randomised study
  • Carcinoma
  • Lung Neoplasms
  • Small Cell Lung Carcinoma

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