Randomized, Phase III-b, Multi-centre, Open-label, Parallel study of Enoxaparin (low molecular weight heparin) given concomitantly with chemotherapy vs chemotherapy alone in patients with inoperable gastric and gastro-oesophageal cancer.

Thrombosis Research Institute0 sites740 target enrollmentTBD

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional

Sponsor

•1\. Signed written informed consent
•2\. Male or Female of age 18\-75 years
•3\. Histologically confirmed gastric or gastro\-oesophageal carcinoma.
•4\. Adenocarcinoma of the stomach stage III or IV considered inoperable at presentation.
•5\. ECOG performance status \< 1
•6\. Criteria for chemotherapy fulfilled (haematological, hepatic, renal).
•7\. Ability to receive daily injection (self\-injection or by patient relative).
•8\. Urine\-Pregnancy test negative.
•9\. Consent to the use of Contraceptive for women of child bearing age group

•1\. History of previous malignancy within the previous 5 years (except curatively treated carcinoma in situ of the uterine cervix, or basal cell carcinoma of the skin), or concomitant malignancy.
•2\. Prior treatment with chemotherapy or radiotherapy if relapse less than 6 months
•3\. Non\-epithelial gastric tumours, borderline tumours.
•4\. Medically unstable patients, including but not limited to those with active infection, acute hepatitis, gastrointestinal bleeding, uncontrolled cardiac arrhythmias, interstitial lung disease, inflammatory bowel disease, uncontrolled angina, uncontrolled hypercalcaemia, uncompensated congestive heart failure, uncontrolled diabetes, persistent renal failure, dementia, seizures, superior vena cava syndrome.
•5\. Persistent renal failure (persistent value of the calculated creatinine clearance \< 30 mL/min defined as a documented value \< 30 mL/min on at least 2 occasions \> 3 days prior entry into the study).
•6\. Prosthetic heart valves.
•7\. Any evidence of active bleeding disorder or risk of bleeding identified on fibroscopy done as a routine investigation before the consent for the trial. Fibroscopy is not mandatory to be done for the trial
•8\. Current, objectively\-verified DVT, PE or other clinically significant thrombosis.
•9\. Documented previous episode of heparin\-induced thrombocytopenia and/or thrombosis (HIT, HAT, or HITTS).
•10\. Contraindications to anticoagulation

Not specified