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 @ 3:29 PM
Ignite Modification Date:
2025-12-24 @ 3:29 PM
NCT ID:
NCT01710592
Eligibility Criteria:
Inclusion Criteria:
* Unresectable or metastatic, histologically confirmed adenocarcinoma of the stomach, gastro-oesophageal junction or lower third of the oesophagus with measurable disease on CT scanning (see RECIST Criteria, Appendix C of the protocol for definition of measureable disease).
* No previous treatment for advanced disease (previous adjuvant/neo-adjuvant treatment acceptable if \>12 months previously).
* Absence of serious concomitant illness (i.e. MI within previous 6 months), uncontrolled angina, uncontrolled hypertension, severe COPD (\>3 admissions for infective exacerbation in past 12 months) etc.
* ECOG performance status ≤ 2.
* Age ≥ to 18.
* Life expectancy ≥ 3 months
* Adequate renal, hepatic and bone marrow function
* Creatinine clearance ≥ 50 ml/min as calculated using the Cockcroft and Gault formula (see Appendix L).
* Liver function tests:
Bilirubin ≤ 1.0 x ULN, AST ≤ 1.5 x ULN, ALT ≤ 1.5 x ULN,Haemoglobin \> 10.0 g/dl, Absolute neutrophil count \>1.5 x 109 /L, Platelet count \> 100 x109/L.
•Before randomisation, written informed consent must be given according to ICH/GCP, and national/local regulations.
Exclusion Criteria:
* Symptoms or signs of peripheral neuropathy.
* Patients known to have second or third degree heart block.
* Previous or concurrent malignancy, with the exception of basal cell carcinoma of the skin or in-situ neoplasia of the uterine cervix.
* Known hypersensitivity to taxanes, oxaliplatin, or fluoropyrimidines.
* Pregnant or nursing.
* Female of child-bearing potential, or male partner of female of child bearing potential not taking adequate contraceptive precautions.
* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01710592
Study Brief:
Protocol Section:
NCT01710592