The clinical hypothesis of this study is that the addition of Panitumumab to the first line treatment combination of docetaxel plus cisplatin will provide benefit to patients with advanced gastric or gastroesophageal junction adenocarcinoma.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
55
Panitumumab, docetaxel and cisplatin combination treatment will be administered for 6 months or until disease progression (PD) according to investigator's criteria unacceptable toxicity or consent withdrawal.
Complejo Hospitalario Universitario de A Coruña
A Coruña, La Coruña, Spain
Centro Oncológico de Galícia
A Coruña, La Coruña, Spain
Hospital Arquitecto Mercide
Ferrol, La Coruña, Spain
Complejo Hospitalario Universitario de Santiago (CHUS)
Objective response rate
To estimate the objective response rate in patients treated with docetaxel, cisplatin and panitumumab as first-line treatment in advanced gastric or gastroesophageal junction adenocarcinoma.
Time frame: 3 years
Disease control rate
Time frame: 3 years
Duration of response
Time frame: 3 years
Time to response
Time frame: 3 years
Time to progression
Time frame: 3 years
Time to treatment failure
Time frame: 3 years
Duration of stable disease
Time frame: 3 years
Progression free survival
Time frame: 3 years
Overall survival
Time frame: 3 years
Safety profile
To describe the safety profile of this combination therapy in the 1st-line setting including the incidence of AE's and changes in laboratory parameters.
Time frame: 3 years
Exploratory Objectives
To investigate the predictive potential of different biomarkers on efficacy and/or safety endpoints.
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Santiago de Compostela, La Coruña, Spain
Hospital Universitario Lucus Augusti
Lugo, Lugo, Spain
Complejo Hospitalario Ourense
Ourense, Ourense, Spain
Hospital de Pontevedra
Pontevedra, Pontevedra, Spain
Complejo Hospitalario Universitario de Vigo (Xeral Cies)
Vigo, Pontevedra, Spain
Policlínica de Vigo S.A.
Vigo, Pontevedra, Spain
Time frame: 3 years