Irinotecan as 3rd Line Therapy in Gastric Cancer

Sponsor
Fudan University
Study ID
NCT02662959
Phase
PHASE2
Status
Unknown

Conditions

  • Stomach Neoplasms

Eligibility Criteria

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

Interventions

  • Irinotecan — DRUG
    180 mg/m2, IV (in the vein) on day 1 of each 14 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.

Study Details

Gastric cancer is the leading cause of cancer death in China. Most patients are unresectable or metastatic disease at the time of diagnosis. Systemic therapy was required for the patients with advanced stage. Platinum combined with fluoropyrimidines always were considered as first line treatment. After failure of initial therapy, single agent of taxanes was used as second line treatment. However, there is no relative standard chemotherapeutic regimen in the third therapy except oral anti-angiogenesis drug-Apatinib. So this study was designed to explore the role of single agent with irinotecan as third line treatment in patients with metastatic gastric cancer in China.

Key Dates

Start date
Apr 30, 2015
Status verified
Nov 2015
Primary completion
May 31, 2018

Study Design

Enrollment
93 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Irinotecan
    In the experimental arm, patients receive single agent of irinotecan as third line treatment in metastatic gastric cancer.

Primary Outcome Measure

Overall Survival [ Time Frame: 1 year ]

Central Contacts

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