Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:45 PM
Ignite Modification Date:
2025-12-24 @ 9:45 PM
NCT ID:
NCT03006432
Eligibility Criteria:
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 (β 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03006432
Study Brief:
Protocol Section:
NCT03006432