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A Phase III Randomised Study Comparing Three Combination Chemotherapy Regimens in Patients With Non Pre-treated Advanced Non-small Cell Lung Cancer


Phase 3
18 Years
N/A
Not Enrolling
Both
Carcinoma, Non-Small-Cell Lung

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Trial Information

A Phase III Randomised Study Comparing Three Combination Chemotherapy Regimens in Patients With Non Pre-treated Advanced Non-small Cell Lung Cancer


Inclusion Criteria:



- Histological or cytological diagnosis of non-small cell lung cancer

- Advanced (unresectable or functionally inoperable) stage III or stage IV disease

- 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

- Operable patient with resectable tumour

- Performance status < 60 on the Karnofsky scale

- A history of prior malignant tumour, except non-melanoma skin cancer or in situ
carcinoma of the cervix and cured malignant tumour (more than 5-year disease free
interval)

- Polynuclear cells < 2,000/mm³

- Platelet cells < 100,000/mm³

- Serum bilirubin >1.5 mg/100 ml

- Serum creatinine > 1.5 mg/100 ml and/or creatinine clearance < 60 ml/min

- Perception hypoacousia

- Peripheral neuropathy

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

- Congestive cardiac failure requiring medical therapy or uncontrolled cardiac
arrhythmia

- 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 first day of registration 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-01041

NCT ID:

NCT00622349

Start Date:

February 2004

Completion Date:

December 2009

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • Randomised phase III
  • Chemotherapy
  • Advanced non-small cell lung carcinoma
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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