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Randomized Phase III Trial of Topotecan and Cisplatin Versus Etoposide and Carboplatin in the Treatment of Patients With Previously Untreated Small Cell Lung Cancer and Extensive Disease


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Extensive Disease, First-Line, Small Cell Lung Cancer

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Trial Information

Randomized Phase III Trial of Topotecan and Cisplatin Versus Etoposide and Carboplatin in the Treatment of Patients With Previously Untreated Small Cell Lung Cancer and Extensive Disease


Inclusion Criteria:



- Histologically confirmed SCLC

- Extensive stage

- No prior chemotherapy

- WHO PS 0-3

- Adequate organ function (liver, kidney)

- Adequate hematology (bone marrow)

- Informed consent

Exclusion Criteria:

- PS 4

- Inadequate organ function

- Uncontrolled infection

- Concomitant major medical contraindications

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

2 years survival

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

Seppo W Langer, MD PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dept. of Oncology, Rigshospitalet, Copenhagen

Authority:

Denmark: Danish Medicines Agency

Study ID:

DOLG7

NCT ID:

NCT00812266

Start Date:

January 2006

Completion Date:

January 2015

Related Keywords:

  • Extensive Disease
  • First-Line
  • Small Cell Lung Cancer
  • SCLC
  • Extensive disease
  • topotecan
  • Lung Neoplasms
  • Small Cell Lung Carcinoma

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