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Randomized, Open-label, phase3 Trial Comparing Amrubicin Combined With Cisplatin Versus Etoposide-Cisplatin as First-line Treatment in Patients With Extensive Disease SCLC


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Lung Cancer

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Trial Information

Randomized, Open-label, phase3 Trial Comparing Amrubicin Combined With Cisplatin Versus Etoposide-Cisplatin as First-line Treatment in Patients With Extensive Disease SCLC


Inclusion Criteria:



- Histologically/cytologically proven small cell lung cancer

- Extensive disease

- No prior chemotherapy regimen

- Age 18 years or older

- ECOG performance status of 0-1

Exclusion Criteria:

- Brain metastasis requiring treatment

- Treatment (Surgical or radiotherapy)of primary tumor

- Interstitial pneumonia or pulmonary fibrosis

- Abnormal cardiac function or myocardial infraction within 6 months before study
enrollment

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:

Overall survival

Outcome Time Frame:

1.5 years after last subject first visit

Safety Issue:

No

Principal Investigator

Yan Sun, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer hospital, Chinese Academy of Medical Science

Authority:

China: Food and Drug Administration

Study ID:

D0750018

NCT ID:

NCT00660504

Start Date:

April 2008

Completion Date:

March 2012

Related Keywords:

  • Lung Cancer
  • Extensive Disease-Small Cell Lung Cancer
  • Lung Neoplasms
  • Small Cell Lung Carcinoma

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