Last updated on July 2018

PHASE III RANDOMISED TRIAL TO EVALUATE FOLFOX WITH OR WITHOUT DOCETAXEL (TFOX) AS 1st LINE CHEMOTHERAPY FOR LOCALLY ADVANCED OR METASTATIC OESOPHAGO-GASTRIC CARCINOMA


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: OESOPHAGO-GASTRIC CARCINOMA
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

Inclusion Criteria:

  • 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
  • Disease measurable according to RECIST v1.1 criteria (at least one measurable lesion)
  • No major surgical procedure during the 4 weeks prior to randomisation:
  • Patient eligible for a 1st line of chemotherapy based on 5FU, folinic acid and oxaliplatin (FOLFOX) with or without docetaxel (TFOX)
  • WHO: 0-1
  • Age 18
  • BMI > 18
  • Life expectancy > 3 months
  • PNN > 1500/mm3, platelets > 100,000/mm3, Hb > 10 g/dL
  • AST, ALT 3.5 times the UNL, alkaline phosphatase < 6 times the UNL
  • Bilirubin 1.5 times the UNL,
  • Creatinine clearance according to Cockcroft and Gault formula > 50 mL/min
  • Women of childbearing age must have a negative pregnancy test ( HCG) before starting treatment
  • Women of childbearing age and men (who are in a sexual relationship with women of childbearing age) must agree to use effective contraception without interruption for the duration of the treatment and for 6 months after administration of the last dose of treatment
  • Patient affiliated to a social security scheme
  • Patient information and signature of informed consent form

Exclusion Criteria:

  • Presence of cerebral or meningeal metastases
  • Presence of > grade 2 neuropathy according to NCIC-CTC 4.0
  • Known DPD deficiency
  • QT/QTc interval > 450 msec for men and > 470 msec for women
  • K+ < LNL, Mg2+ < LNL, Ca2+ < LNL
  • Any known specific contraindication or allergy to the treatments used in the study (cf RCP Appendix 7)
  • Chemotherapy or radio-chemotherapy in an adjuvant situation finished less than 12 months ago
  • Prior chemotherapy including oxaliplatin (except for adjuvant chemotherapy)
  • Prior chemotherapy including docetaxel
  • Any progressive pathology not stabilised over the past 6 months: liver impairment, renal impairment, respiratory or cardiac failure
  • HIV+ patients
  • Radiotherapy during the 4 weeks prior to randomisation
  • Other concomitant cancer or a history of cancer during the previous 5 years, with the exception of carcinoma in situ of the cervix or basal cell carcinoma or epidermoid cell carcinoma of the skin which is considered to be cured
  • Patient already included in another clinical trial involving an experimental drug
  • Pregnant or breastfeeding woman
  • Persons in custody or under wardship
  • Impossibility of undergoing medical monitoring during the trial for geographical, social or psychological reasons

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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