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. 2017 Aug 29;2017(8):CD004064. doi: 10.1002/14651858.CD004064.pub4

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
  1. Drug: 5Fluorouracil bolus

  2. Drug: 5Fluorouracil continuous

  3. Drug: docetaxel

  4. Drug: folinic Acid

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