NCT03006432.
Trial name or title | ASE III randomised trial to evaluate folfox with or without docetaxel (TFOX) as 1st line chemotherapy for locally advanced or metastatic oesophago‐gastric carcinoma (GASTFOX) |
Methods | Phase 3 Allocation: Randomised Intervention Model: Parallel assignment Masking: No masking Primary Purpose: Treatment |
Participants | N = 506 Gastric or gastro‐oesophageal junction adenocarcinoma (all Siewert), histologically proven (on primary tumour or metastatic lesion), HER2 negative (positive HER2 status is defined by a positive IHC test of 3+ or IHC of 2+ with positive FISH) Metastatic or non‐resectable (locally advanced) disease |
Interventions | Active Comparator: FOLFOX Cycles every 15 days until progression disease Experimental: TFOX Cycles every 15 days until progression disease Interventions: Drug: oxaliplatin
|
Outcomes | Progression‐free survival [Time frame: 12 months after last randomisation] Overall survival toxicity events (adverse events) according to NCI‐CTC v4.0 [Time frame: 12 months after last randomisation] Objective response rate [Time frame: 12 months after last randomisation] Toxicity events according to NCI‐CTC v4.0 [Time frame: 12 months after last randomisation] |
Starting date | December 2016 |
Contact information | Contact: Marie MOREAU +33 (0)380393404 marie.moreau@u‐bourgogne.fr |
Notes | PRODIGE 51 |