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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) (SYRINGES)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00771563
Recruitment Status : Completed
First Posted : October 13, 2008
Last Update Posted : June 28, 2013
Universiteit Antwerpen
Information provided by (Responsible Party):
Ethisch Comité UZ Antwerpen, University Hospital, Antwerp

Brief Summary:

Rationale: a number of recent phase III randomized trials have shown a survival benefit of a treatment with subcutaneous low-molecular weight heparin in patients with advanced solid malignancies. The survival advantages observed in the studies persist for months after the active treatment with LMWHs. Therefore these survival advantages are thought to be due to effects of LMWHs on tumor cell biology.

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.

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Drug: cisplatin + docetaxel Drug: cisplatin + docetaxel + enoxaparin Phase 3

Detailed Description:
Purpose: the aim of this study is to evaluate the potential beneficial antitumoral effect of LMWH enoxaparin in patients with locally advanced or metastatic NSCLC determined by the time to progression, the overall survival and the symptom control. LMWH will be added to a first line cisplatin-based chemotherapy.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Low Molecular Weight Heparin in Advanced Non Small Cell Lung Cancer (NSCLC): a Randomized Open Label Phase III Study Evaluating the Effect of Enoxaparin (Clexane) on Survival and Symptom Control in Patients With Stage IIIB and IV NSCLC Undergoing a Cisplatin Based First Line Chemotherapy: the SYRINGES Trial
Study Start Date : June 2008
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Arm Intervention/treatment
Active Comparator: Arm A
Chemotherapy without LMWH
Drug: cisplatin + docetaxel
docetaxel 75 mg/m2 d1 and cisplatin 75mg/m2 d1 (q 3wks for 4 cycles)
Other Names:
  • Platinol
  • Taxotere

Experimental: Arm B
Chemotherapy with LMWH
Drug: 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 Names:
  • Platinol
  • Taxotere
  • Clexane
  • LMWH

Primary Outcome Measures :
  1. Progression Free Survival [ Time Frame: during chemotherapy and follow-up ]

Secondary Outcome Measures :
  1. Symptom control evaluated with the Lung Cancer Symptoms Scale (LCSS) [ Time Frame: during chemotherapy and follow-up ]
  2. Overall Survival [ Time Frame: during chemotherapy and follow-up ]
  3. Best Overall Response [ Time Frame: during chemotherapy and follow-up ]
  4. Incidence of total documented thromboembolic and hemorrhagic events [ Time Frame: during chemotherapy and follow-up ]
  5. Overall safety and tolerability [ Time Frame: during chemotherapy and follow-up ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Locally advanced or metastatic NSCLC (stage IIIB or IV)
  • 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:

  • Previous chemotherapy for NSCLC
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00771563

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University Hospital Antwerp
Edegem, Antwerp, Belgium, 2650
Centre Hospitalier Universitaire Sart Tilman
Liège, Belgium, 4000
Sponsors and Collaborators
University Hospital, Antwerp
Universiteit Antwerpen
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Principal Investigator: Paul R Germonpre, MD PhD Universiteit Antwerpen
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Ethisch Comité UZ Antwerpen, Thoracale Oncologie Groep Antwerpen, University Hospital, Antwerp Identifier: NCT00771563    
Other Study ID Numbers: TOGA 0601
EudraCT 2007-007696-16
First Posted: October 13, 2008    Key Record Dates
Last Update Posted: June 28, 2013
Last Verified: June 2013
Keywords provided by Ethisch Comité UZ Antwerpen, University Hospital, Antwerp:
Non-Small Cell Lung Cancer
Low Molecular Weight Heparin
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Fibrinolytic Agents
Fibrin Modulating Agents