Pre-operation Chemo and Antibody Therapy Followed by Surgical Resection and Adjuvant Chemoradiation for Gastric Cancer
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|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: ErbituxDrug: Irinotecan
Other Names:Drug: Cisplatin
Other Name: Platinol-AQProcedure: Surgery Drug: 5-FU
Other Name: FluorourocilRadiation: Radiation
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|