Study to Compare Irinotecan Combined With Cisplatin (IP) Versus Etoposide Combined With Cisplatin (EP) in Advanced and Metastatic Gastrointestinal Pancreatic and Esophageal Neuroendocrine Carcinoma

Sponsor
Peking University
Study ID
NCT03168594
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • irinotecan cisplatin — DRUG
    Irinotecan：60mg/m2 ，iv drip for 90min，d1,8 q3W cisplatin: 60mg/m2 ，iv drip for 120min，d1 q3W
  • Etoposide cisplatin — DRUG
    Etoposide：100mg/m2 ，iv drip for 60min，d1-3 q3W cisplatin: 75mg/m2 ，iv drip for 120min，d1 q3W

Study Details

The study will be conducted to compare the safety and efficacy of irinotecan combined with cisplatin (IP regimen) and etoposide combined with cisplatin (EP regimen) in advanced or metastatic gastrointestinal pancreatic and esophageal neuroendocrine carcinoma. In this prospective randomized phase II study, the investigators aim to compare the survival benefit as well as the safety for irinotecan combined with cisplatin (IP regimen) versus etoposide combined with cisplatin (EP regimen) in advanced or metastatic gastrointestinal pancreatic and esophageal neuroendocrine carcinoma.

Key Dates

Start date
Apr 29, 2017
Status verified
Jan 2020
Primary completion
Feb 20, 2019
Completion
Sep 20, 2019

Study Design

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

Arms

  • Experimental: A:Irinotecan combined with cisplatin (IP regimen)
    patients in arm A will receive chemotherapy of IP regimen: Irinotecan：60mg/m2 ，iv drip for 90min，d1,8 q3W cisplatin: 60mg/m2 ，iv drip for 120min，d1 q3W
  • Experimental: B:Etoposide combined with cisplatin (EP regimen)
    patients in arm B will receive chemotherapy of EP regimen: Etoposide：100mg/m2 ，iv drip for 60min，d1-3 q3W cisplatin: 75mg/m2 ，iv drip for 120min，d1 q3W

Primary Outcome Measure

Overall response rate (ORR) [ Time Frame: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months ]

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