Open-label clinical trial of Enoxaparin (low molecular weight heparin) given concomitantly with chemotherapy vs chemotherapy alone in patients with inoperable gastric and gastro-oesophageal cancer.
- Registration Number
- CTRI/2009/091/000885
- Lead Sponsor
- Thrombosis Research Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 740
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
Coagulopathies (acquired or inherited)
Prior history of cerebral hemorrhage or neurosurgery within the previous month
Bacterial endocarditis
Uncontrolled arterial hypertension (systolic BP >200 mmHg or diastolic BP >110 mmHg) at 2 successive readings
Haemostatic abnormalities: circulating anticoagulant, baseline platelet count <50 000/mm3, activated partial thromboplastin time (aPTT) value 1.5 x the upper limit of normal, or International Normalized Ratio (INR) >1.5. The laboratory test valid would be no earlier than 14 days for this criterion.
Indication for thrombolytic therapy
Any long-term anticoagulant therapy for medical condition.
11. Immunocompromised subjects, such as subjects with known HIV and those who have either had an AIDS-defining condition (e.g. Kaposi?s sarcoma, Pneumocystitis carinii pneumonia) or have CD4 + T-lymphocyte count < 200 /mm3.
12. Known hypersensitivity to heparin, or LMWH, or pork derived products.
13. Body weight >100 kg.
14. Pregnant or lactating women.
15. Women of childbearing potential not protected by effective contraceptive method of birth control and/or who are unwilling to be tested for pregnancy (pregnancy status should be checked by serum or urine pregnancy testing prior to exposure to the investigational product
16. Participation in another clinical trial (study medications / study devices) within the previous 30 days. (Surgical trials are allowed).
17. Psychiatric disorders of altered mentation that would preclude understanding of the informed consent process.
18. Psychological, familial, sociological, or geographical conditions, which do not permit treatment and/or medical follow-up required to comply with the study protocol
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Event Free Survival (EFS)<br>[Composite endpoint of 1 year Survival and 1 year free of SVTE]Timepoint: Composite endpoint of 1 year Survival and 1 year free of SVTE
- Secondary Outcome Measures
Name Time Method Efficacy<br>Incidence of SVTE<br>Overall survival<br>All causes of death<br>Safety:<br>Major and minor haemorrhages during study treatment period and up to 30 days after last dose.<br>Serious adverse events,<br>All reported adverse events<br>HITTimepoint: Major and minor haemorrhages during study treatment period and up to 30 days after last dose.