Irinotecan Plus S1 Versus S1 in Patients With Previously Treated Advanced Esophageal Cancer: ESWN 01 Trial

Sponsor
Chinese Academy of Medical Sciences
Study ID
NCT02319187
Phase
PHASE3
Status
Unknown

Conditions

  • Esophageal Neoplasms

Eligibility Criteria

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

Interventions

  • S1 — DRUG
    S1 80mg to 120 mg per day on Days 1-14, every 21 days
  • S-1 — DRUG
    S1 80mg to 120 mg per day on Days 1-10, every 14 days;
  • irinotecan — DRUG
    irinotecan 160mg/m2 d1, every 14 days

Study Details

Esophageal cancer is a highly aggressive malignancy with a poor overall outcome. The purpose of this study is to evaluate the progression free survival and safety of irinotecan plus S1 versus S1 alone in the patients with previously treated advanced esophageal cancer

Key Dates

Start date
Dec 31, 2014
Status verified
Apr 2015
Primary completion
Dec 31, 2016
Completion
Jun 30, 2017

Study Design

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

Arms

  • Active Comparator: Arm A
    S1
  • Experimental: Arm B
    S1 and irinotecan

Primary Outcome Measure

progression free survival [ Time Frame: 2 ]

Central Contacts

  • Jing Huang, M.D.
    8610-87788103

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