Phase II Study of Irinotecan and Cisplatin in Extensive-stage Small Cell Lung Cancer

Sponsor
Chinese Academy of Medical Sciences
Study ID
NCT02323737
Phase
PHASE2
Status
Completed

Conditions

  • Extensive-stage Small Cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

Patients with untreated extensive-stage small cell lung cancer(SCLC) were randomly assigned to receive either irinotecan/cisplatin (IP) or etoposide/cisplatin(EP), The association of efficacy and toxicity of IP regimen was analyzed.

Key Dates

Start date
Jul 31, 2010
Status verified
Dec 2014
Primary completion
Jun 30, 2011
Completion
Jun 30, 2012

Study Design

Enrollment
62 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Irinotecan and cisplatin
    The IP regimen consisted of at most 6 cycles of irinotecan 65 mg/m2 of body-surface area on days 1, 8 and cisplatin 75mg/m2 of body-surface area on day 1.
  • Active Comparator: Etoposide and Cisplatin
    The EP regimen consisted of at most 6 cycles of etoposide 100 mg/m2 of body-surface area from day 1 to 3 and cisplatin 75mg/m2 of body-surface area on day 1.

Primary Outcome Measure

progression-free survival [ Time Frame: 1 month ]

Related Studies