The DISTAL-2 Study: Docetaxel Alone or in Combination in Second-line Treatment of Advanced Non Small-Cell Lung Cancer

Sponsor
National Cancer Institute, Naples
Study ID
NCT00345059
Phase
PHASE3
Status
Terminated

Conditions

  • Advanced Non-Small Cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
N/A - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • docetaxel — DRUG
  • vinorelbine — DRUG
  • gemcitabine — DRUG
  • capecitabine — DRUG

Study Details

The purpose of this study is to compare the overall survival of patients with advanced non small cell lung cancer treated with docetaxel as single therapy versus docetaxel in combination with either gemcitabine or vinorelbine or in combination with capecitabine.

Key Dates

Start date
May 31, 2005
Status verified
Jan 2016
Primary completion
May 31, 2008
Completion
May 31, 2008

Study Design

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

Arms

  • Active Comparator: docetaxel
    single agent docetaxel
  • Experimental: docetaxel + vinorelbine OR gemcitabine
    docetaxel in combination with either vinorelbine or with gemcitabine
  • Experimental: docetaxel + capecitabine
    docetaxel in combination with capecitabine

Primary Outcome Measure

overall survival [ Time Frame: one year ]

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