Enoxaparin Low Molecular Weight Heparin (LMWH) in Advanced Non Small Cell Lung Cancer: Effect on Survival and Symptom Control in Patients Undergoing First Line Chemotherapy (SYRINGES)
NCT ID: NCT00771563
Last Updated: 2013-06-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
104 participants
INTERVENTIONAL
2008-06-30
2012-10-31
Brief Summary
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First line treatment of advanced NSCLC patients with the Cisplatin + Docetaxel combination has been widely studied, and is amongst the most active treatments currently available. The occurrence of grade 3/4 thrombopenia in several phase III trials was in the 0-3% range, making it an ideal chemotherapy regimen to combine with LMWHs in the treatment of advanced NSCLC.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A
Chemotherapy without LMWH
cisplatin + docetaxel
docetaxel 75 mg/m2 d1 and cisplatin 75mg/m2 d1 (q 3wks for 4 cycles)
Arm B
Chemotherapy with LMWH
cisplatin + docetaxel + enoxaparin
cisplatin 75 mg/m2 d1 and docetaxel 75 mg/m2 d1 (q 3 wks for 4 cycles) + daily enoxaparin 1mg/kg/d sc
Interventions
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cisplatin + docetaxel
docetaxel 75 mg/m2 d1 and cisplatin 75mg/m2 d1 (q 3wks for 4 cycles)
cisplatin + docetaxel + enoxaparin
cisplatin 75 mg/m2 d1 and docetaxel 75 mg/m2 d1 (q 3 wks for 4 cycles) + daily enoxaparin 1mg/kg/d sc
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients who are not candidates for radical combined modality treatments or high-dose radiation therapy
* At least one measurable lesion according to RECIST criteria
* Good performance status
* Adequate haematological, renal and liver function
* Written informed consent
Exclusion Criteria
* Brain metastasis
* History of cerebral haemorrhage, neurosurgery within 3 previous months or surgery within the past 6 months
* Indication for anticoagulant therapy, thrombolytic therapy or antiplatelet therapy for cardiovascular disease
* Concomitant therapy with an anti-angiogenesis agent
* Contra-indication for LMWH
* Life expectancy of \< 3 months
* Serious concomitant systemic disease, uncontrolled arterial hypertension, active peptic ulcer or other condition which does not permit study treatment or follow-up required to comply with the study protocol
18 Years
ALL
No
Sponsors
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Universiteit Antwerpen
OTHER
University Hospital, Antwerp
OTHER
Responsible Party
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Ethisch Comité UZ Antwerpen
Thoracale Oncologie Groep Antwerpen
Principal Investigators
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Paul R Germonpre, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Universiteit Antwerpen
Locations
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University Hospital Antwerp
Edegem, Antwerp, Belgium
Centre Hospitalier Universitaire Sart Tilman
Liège, Liège, Belgium
Countries
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References
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Rutjes AW, Porreca E, Candeloro M, Valeriani E, Di Nisio M. Primary prophylaxis for venous thromboembolism in ambulatory cancer patients receiving chemotherapy. Cochrane Database Syst Rev. 2020 Dec 18;12(12):CD008500. doi: 10.1002/14651858.CD008500.pub5.
Other Identifiers
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EudraCT 2007-007696-16
Identifier Type: -
Identifier Source: secondary_id
TOGA 0601
Identifier Type: -
Identifier Source: org_study_id
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