Clinical trial · Interventional
Overall Survival of Inoperable Gastric/GastroOesophageal Cancer Subjects on Treating With LMWH + Chemotherapy(CT) vs Standard CT
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Due to evidence available both in terms of efficacy and safety of low molecular weight heparin, its use for the prevention of thromboembolic disease in cancer patients undergoing surgical intervention, and its extended use in higher doses for the prevention of recurrent thromboembolism in cancer patients with established thrombosis, with a view that the potential benefits for survival in cancer patients from low molecular weight heparin therapy comes because of a biological activity, the dose of 1mg/Kg (50% of the full treatment dose) for a period of 6 months coincident with 6 cycles of chemotherapy, has been chosen for this study.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Gastroesophageal Cancer | Gastric Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Enoxaparin | Drug | — | UNRESOLVED |
| Standard Chemotherapy | Drug | Chemotherapy | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- B
- description
- Standard Chemotherapy (upto 6 cycles)
- interventionNames
- Drug: Standard Chemotherapy
- type
- EXPERIMENTAL
- label
- A
- description
- Enoxaparin: 1 mg/kg once daily in addition to standard chemotherapy up to 6 months
- interventionNames
- Drug: Enoxaparin
Primary outcomes (1)
- measure
- Event Free Survival (EFS) - Composite endpoint of overall survival plus free of symptomatic VTE .
- timeFrame
- up to 1 year from start of treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Signed written informed consent * Male or Female of age 18-75 years * Histologically confirmed gastric or gastro-oesophageal carcinoma. * Adenocarcinoma of the stomach stage III or IV considered inoperable at presentation. * ECOG performance status ≤ 1 * Criteria for chemotherapy fulfilled (haematological, hepatic, renal). * Ability to receive daily injection (self-injection or by patient relative). * Urine-Pregnancy test negative. * Consent to the use of Contraceptive for women of child bearing age group Exclusion Criteria: * 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. * Prior treatment with chemotherapy or radiotherapy if relapse less than 6 months * Non-epithelial gastric tumours, borderline tumours. * 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. * 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). * Prosthetic heart valves. * 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 * Current, objectively-verified DVT, PE or other clinically significant thrombosis. * Documented previous episode of heparin-induced thrombocytopenia and/or thrombosis (HIT, HAT, or HITTS). * 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. * 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. * Known hypersensitivity to heparin, or LMWH, or pork derived products. * Body weight \>100 kg. * Pregnant or lactating women. * 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 * Participation in another clinical trial (study medications / study devices) within the previous 30 days. (Surgical trials are allowed). * Psychiatric disorders of altered mentation that would preclude understanding of the informed consent process. * Psychological, familial, sociological, or geographical conditions, which do not permit treatment and/or medical follow-up required to comply with the study protocol.
References
Publications (18)
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- BACKGROUNDGreenlee RT, Murray T, Bolden S, Wingo PA. Cancer statistics, 2000. CA Cancer J Clin. 2000 Jan-Feb;50(1):7-33. doi: 10.3322/canjclin.50.1.7. PMID 10735013
- BACKGROUNDCohen AT, Wagner MB, Mohamed MS. Risk factors for bleeding in major abdominal surgery using heparin thromboprophylaxis. Am J Surg. 1997 Jul;174(1):1-5. doi: 10.1016/S0002-9610(97)00050-0. PMID 9240942
- BACKGROUNDAjani JA. Chemotherapy for gastric carcinoma: new and old options. Oncology (Williston Park). 1998 Oct;12(10 Suppl 7):44-7. PMID 9830625
- BACKGROUNDPanzini I, Gianni L, Fattori PP, Tassinari D, Imola M, Fabbri P, Arcangeli V, Drudi G, Canuti D, Fochessati F, Ravaioli A. Adjuvant chemotherapy in gastric cancer: a meta-analysis of randomized trials and a comparison with previous meta-analyses. Tumori. 2002 Jan-Feb;88(1):21-7. PMID 12004845
- BACKGROUNDPetralia GA, Lemoine NR, Kakkar AK. Mechanisms of disease: the impact of antithrombotic therapy in cancer patients. Nat Clin Pract Oncol. 2005 Jul;2(7):356-63. doi: 10.1038/ncponc0225.