Pre-operation Chemo and Antibody Therapy Followed by Surgical Resection and Adjuvant Chemoradiation for Gastric Cancer

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT00857246
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Cetuximab — DRUG
  • Irinotecan — DRUG
  • Cisplatin — DRUG
  • Surgery — PROCEDURE
  • 5-FU — DRUG
  • Radiation — RADIATION

Study Details

This study intends to evaluate the feasibility and treatment efficacy of adding an antibody blocking the epidermal growth factor (EGF) pathway to a neoadjuvant approach with proven efficacy developed at New York University.

Key Dates

Start date
Jul 31, 2005
Status verified
Nov 2015
Primary completion
Sep 30, 2011
Completion
Oct 31, 2015

Study Design

Enrollment
30 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Induction/ surgery/ chemoRT
    1. Induction treatment (3 weeks/cycle x 4 cycles): Cisplatin and Irinotecan on days 1 and 8; Cetuximab on days 1, 8, and 15. 2. Surgery (starts 3-4 weeks after induction treatment). 3. Chemoradiation treatment (starts 4-6 weeks after surgery): weeks 1-19: Cetuximab on day 1 of every week; week 1: 5-FU and Leucovorin (LV) x 5 days; weeks 2-4: recovery; weeks 5-9: radiation, 150 cGy x 5 fractions/week x 5 weeks; week 5: 5-FU+ LV on days 1-4; week 9: 5-FU+ LV on days 1-3; weeks 14 and 19: 5-FU+LV x 5days

Primary Outcome Measure

Clinical Response Rate of an Induction Regimen Consisting of Irinotecan, Cisplatin and Cetuximab [ Time Frame: 4 months from the beginning of the induction regimen ]

Locations (1)

FacilityCityStateZIPSite coordinators
NYU Cancer CenterNew YorkNew York10016-

Find similar trials in New York, NY

By condition
Gastric cancer
By specialty
OncologyGI oncology
By research site
NYU Cancer Center· New York, NY

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