Irinotecan Combined With Cisplatin as 1st Line Treatment for Esophageal Squamous Cell Cancer : a Single Center Prospective Clinical Trial

Sponsor
Peking University
Study ID
NCT01051765
Phase
PHASE2
Status
Unknown

Conditions

  • Advanced Esophageal Squamous Carcinoma

Eligibility Criteria

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

Interventions

Study Details

Irinotecan, as one new agent used in advanced esophageal carcinoma, has been shown to be effective and safe in western studies. Different with westerns, squamous carcinoma is the main pathological type in china patients. The investigators then initiated a prospective phase II clinical trial with irinotecan/cisplatin as the 1st line treatment in advanced esophageal carcinoma to observe the efficacy and safety of the combination.

Key Dates

Start date
Aug 31, 2009
Status verified
May 2009
Primary completion
Aug 31, 2011
Completion
Aug 31, 2012

Study Design

Enrollment
60 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: irinotecan/cisplatin
    irinotecan 130mg/m2 d1 cisplatin: 30mg/m2, d1,d2 every three weeks

Primary Outcome Measure

overall survival [ Time Frame: 2 year ]

Central Contacts