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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)

This study has been completed.
Universiteit Antwerpen
Information provided by (Responsible Party):
Ethisch Comité UZ Antwerpen, University Hospital, Antwerp Identifier:
First received: October 10, 2008
Last updated: June 27, 2013
Last verified: June 2013

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 Intervention Phase
Non-Small Cell Lung Cancer Drug: cisplatin + docetaxel Drug: cisplatin + docetaxel + enoxaparin Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Ethisch Comité UZ Antwerpen, University Hospital, Antwerp:

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

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

Enrollment: 104
Study Start Date: June 2008
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00771563

University Hospital Antwerp
Edegem, Antwerp, Belgium, 2650
Centre Hospitalier Universitaire Sart Tilman
Liège, Belgium, 4000
Sponsors and Collaborators
University Hospital, Antwerp
Universiteit Antwerpen
Principal Investigator: Paul R Germonpre, MD PhD Universiteit Antwerpen
  More Information

Responsible Party: Ethisch Comité UZ Antwerpen, Thoracale Oncologie Groep Antwerpen, University Hospital, Antwerp Identifier: NCT00771563     History of Changes
Other Study ID Numbers: TOGA 0601
EudraCT 2007-007696-16
Study First Received: October 10, 2008
Last Updated: June 27, 2013

Keywords provided by Ethisch Comité UZ Antwerpen, University Hospital, Antwerp:
Non-Small Cell Lung Cancer
Low Molecular Weight Heparin

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Calcium heparin
Heparin, Low-Molecular-Weight
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Fibrinolytic Agents
Fibrin Modulating Agents processed this record on August 16, 2017