The primary aim of this study is to determine if the addition of valproic acid to a combination of adriamycin, cyclophosphamide and vindesine could increase progression-free survival in patients relapsing after first-line chemotherapy including platinum derivatives, cisplatin or carboplatin, and etoposide.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
64
Adriamycin 45 mg/m² day 1 IV Cyclophosphamide 1 g/m² day 1 IV Vindesine 3 mg/m² day 1 IV Valproic acid 20-30 mg/kg/day from day -7 until the end of treatment, orally
Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet
Brussels, Belgium
Department of Pneumology CHU Charleroi
Charleroi, Belgium
Department of Pneumology Hôpital Saint-Joseph
Gilly, Belgium
Hôpital Ambroise Paré
Mons, Belgium
Six-months progression-free survival
Time frame: The period between the day of registration and the date of first progression
Survival
Time frame: Survival will be dated from the date of registration
Response rate
Time frame: Every three cycles of chemotherapy
Toxicity
Time frame: After each course of chemotherapy and at the end of treatment
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Department of Pneumology Centre Hospitalier de Mouscron
Mouscron, Belgium