Irinotecan Plus Cisplatin Compared With Etoposide Plus Cisplatin for Extensive Stage Small-cell Lung Cancer

Sponsor
Guangdong Association of Clinical Trials
Study ID
NCT02348450
Phase
PHASE4
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • Irinotecan — DRUG
    40mg
  • Etoposide — DRUG
    5ml：0.1g
  • Cisplatin — DRUG
    6ml：30mg

Study Details

This study is aimed to evaluate the progression-free survival(PFS) and also survival of IP and EP (head-to-head) as the first line therapy for extensive stage small-cell lung cancer and to explore the reasonable first-line therapy for Chinese population. An open-label, multi-center study will be conducted with dynamic randomization of approximately 1:1 ratio with an estimation of 308 eligible participants.

Key Dates

Start date
Feb 28, 2015
Status verified
Dec 2016
Primary completion
Feb 28, 2017
Completion
Dec 31, 2018

Study Design

Enrollment
308 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Irinotecan plus Cisplatin
    first line: irinotecan 65mg/m2 d1,8. Cisplatin 30mg/m2，d1,8, 21days/cycle×6 cycles Second-line: etoposide alone OR etoposide plus cisplatin, dosage will be same as first line or on investigator's discretion.
  • Experimental: Etoposide plus Cisplatin
    first line: etoposide 60mg/m2 d1-5 Cisplatin 75mg/m2，d1(recommended), or administer three times with same total daily dose , 21days/cycle×6 cycles Second-line: irinotecan alone or irinotecan plus cisplatin, dosage is same as first line or on investigator's discretion.

Primary Outcome Measure

Progression free survival of first line therapy [ Time Frame: 24 months ]

Central Contacts

Related Studies