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A Randomized Prospective Multicenter Trial of Belotecan/Cisplatin Versus Etoposide/Cisplatin in Patients With Previously Untreated, Extensive-stage Small-cell Lung Cancer


Phase 3
19 Years
80 Years
Open (Enrolling)
Both
Carcinoma, Small Cell

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Trial Information

A Randomized Prospective Multicenter Trial of Belotecan/Cisplatin Versus Etoposide/Cisplatin in Patients With Previously Untreated, Extensive-stage Small-cell Lung Cancer


Inclusion Criteria:



- ECOG Performance status 0~2(those with performance status 2 must have been stable
with no deterioration over the previous 2 weeks)

- Histologically or cytologically confirmed small cell lung cancer Patient without
chemotherapy and radiotherapy

- Measurable lesion according to RECIST with at least one measurable lesion not
previously irradiated, unless disease progression has been documented at that site

- Life expectancy of at least 3 months

- Provision of written informed consent

Exclusion Criteria:

- As judged by the investigator, any evidence of severe or uncontrolled systemic
disease

- Serum bilirubin greater than 3 times the upper limit of reference range(ULRR)

- Aspartate aminotransferase (AST/SGOT) or alanine aminotransferase (ALT/SGPT)greater
than 2.5 times ULN if no demonstrable liver metastases (or > 5 times in presence of
liver metastases)

- Evidence of any other significant clinical disorder or laboratory finding that makes
it undesirable for the subject to participate in the study

- Pregnancy or breast-feeding women(women of child-bearing potential). Women of
childbearing potential must practice acceptable methods of birth control to prevent
pregnancy

- Evidence of brain metastasis

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:

To assess the response Rate of Belotecan/Cisplatin versus Etoposide/Cisplatin in patients with previously untreated, extensive-stage small cell lung cancer

Outcome Time Frame:

two years

Safety Issue:

No

Principal Investigator

In-Jae Oh, M.D.,Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Chonnam National University Hospital

Authority:

South Korea: Institutional Review Board

Study ID:

CSCLC-0810

NCT ID:

NCT00826644

Start Date:

January 2009

Completion Date:

December 2012

Related Keywords:

  • Carcinoma, Small Cell
  • Small cell lung cancer
  • Camptothecin
  • Response rate
  • Carcinoma
  • Lung Neoplasms
  • Small Cell Lung Carcinoma
  • Carcinoma, Small Cell

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