The primary objective is to evaluate six months survival rate and quality of life at 4 months of ramucirumab alone or in combination with paclitaxel in patients aged 70 years or more who have stomach or GEJ adenocarcinoma and whose first line of fluoropyrimidine- and platinumcontaining treatment has failed. The co-primary endpoints are the following: * Six months survival rate * Quality of life at 4 months as assessed by the following three target dimensions of the EORTC QLQ-ELD14 questionnaire: mobility, illness burden and worries about the future
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
112
IV ramucirumab at 8 mg/kg on D1 and D15
IV paclitaxel at 80 mg/m² on D1, D8 and D15
CH -
Abbeville, France
CH - Albi
Albi, France
PRIVEE - L'Europe
Amiens, France
CAC - ICO Site Paul Papin
Angers, France
Privee - Hopital Prive
Antony, France
Ch - Victor Dupouy
Argenteuil, France
Patient survival rate at 6 months
Rate of patients alive
Time frame: at 6 months
Quality of life at 4 months as assessed by the following dimension of the EORTC QLQ-ELD14 questionnaire: mobility
Derived from items 31,33 and 34of the ELD14 questionnaire. The score is from 0 to 100. The endpoint is defined as the difference of at least 10 points (clinical significance) between baseline score and 4-months score.
Time frame: at 4 months
Quality of life at 4 months as assessed by the following dimension of the EORTC QLQ-ELD14 questionnaire: worries about the future
Derived from items 31,33 and 34of the ELD14 questionnaire. The score is from 0 to 100. The endpoint is defined as the difference of at least 10 points (clinical significance) between baseline score and 4-months score.
Time frame: at 4 months
Quality of life at 4 months as assessed by the following dimension of the EORTC QLQ-ELD14 questionnaire: illness burden
Derived from items 43 and 44of the ELD14 questionnaire. The score is from 0 to 100. The endpoint is defined as the difference of at least 10 points (clinical significance) between baseline score and 4-months score
Time frame: at 4 months
Overall survival
Defined as time to death (whatever cause is) or for patients alive time to last news.
Time frame: 6 months
Time to treatment failure
Time between randomization and disease progression, treatment interruption or death
Time frame: 6 months
Progression-free survival
Progression-free survival (clinical and/or radiological) determined by the investigator based on RECIST V1.1
Time frame: 6 months
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Ch - Metz Thionville Mercy
Ars-Laquenexy, France
Ch - Ght Unyon Auxerre
Auxerre, France
Privee - Institut Du Cancer Avignon Provence
Avignon, France
Ch - Cote Basque
Bayonne, France
...and 28 more locations