Pre-operation Chemo and Antibody Therapy Followed by Surgical Resection and Adjuvant Chemoradiation for Gastric Cancer
|ClinicalTrials.gov Identifier: NCT00857246|
Recruitment Status : Completed
First Posted : March 6, 2009
Results First Posted : March 13, 2015
Last Update Posted : December 7, 2015
|Condition or disease||Intervention/treatment||Phase|
|Gastric Cancer Stomach Cancer||Drug: Cetuximab Drug: Irinotecan Drug: Cisplatin Procedure: Surgery Drug: 5-FU Radiation: Radiation||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Neoadjuvant Therapy of Gastric Cancer With Irinotecan, Cisplatin and Cetuximab Followed by Surgical Resection and Adjuvant Chemoradiation|
|Study Start Date :||July 2005|
|Actual Primary Completion Date :||September 2011|
|Actual Study Completion Date :||October 2015|
Experimental: Induction/ surgery/ chemoRT
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
Other Name: Erbitux
Other Name: Platinol-AQ
Other Name: Fluorourocil
- Clinical Response Rate of an Induction Regimen Consisting of Irinotecan, Cisplatin and Cetuximab [ Time Frame: 4 months from the beginning of the induction regimen ]Clinical response rate is defined as the percentage of patients who responded to the induction regimen. The response is determined based on endoscopic ultrasonography (EUS) staging pre-treatment and post-treatment, CT scans pre- and post- operatively, and initial clinical stage (based on these tests) compared with the pathologic stage. Any "down-staging" of T or N stage is considered to be a result of induction therapy and counted as a clinical response.
- Rate of Clearance of Nodal Involvement Among Patients Who Have Received the Induction Therapy [ Time Frame: 4 months from the beginning of the induction treatment ]This is defined as the percentage of patients whose nodal involvement of cancer has been cleared based on surgery results.
- Rate of Potentially Curative Surgery [ Time Frame: 4 months from the beginning of the induction treatment ]This is defined as the percentage of patients who underwent curative surgery (surgery to remove all cancerous tissue).
- Rate of "Down-staging" From Pre-operative Clinical Staging [ Time Frame: 4 months from the beginning of the induction treatment ]This is defined as the percentage of patients who had a reduction from T3/T4 disease.
- Safety of the Induction Regimen [ Time Frame: 4 months from the beginning of the induction ]This describes the number of patients who experienced grade 3 and higher adverse events related to the regimen.
- Median Overall Survival (Induction Treatment and Curative Surgery) [ Time Frame: up to 5 years ]This is the length of time from the start of treatment that half of the patients are still alive.
- Median Overall Survival (Adjuvant Therpary) [ Time Frame: up to 5 years ]This is the length of time from the start of treatment that half of the patients are still alive.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00857246
|United States, New York|
|NYU Cancer Center|
|New York, New York, United States, 10016|
|Principal Investigator:||Theresa Ryan, MD||New York University School of Medicine|