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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)

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ClinicalTrials.gov Identifier: NCT00771563
Recruitment Status : Completed
First Posted : October 13, 2008
Last Update Posted : June 28, 2013
Sponsor:
Collaborator:
Universiteit Antwerpen
Information provided by (Responsible Party):
Ethisch Comité UZ Antwerpen, University Hospital, Antwerp

Tracking Information
First Submitted Date  ICMJE October 10, 2008
First Posted Date  ICMJE October 13, 2008
Last Update Posted Date June 28, 2013
Study Start Date  ICMJE June 2008
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 10, 2008)
Progression Free Survival [ Time Frame: during chemotherapy and follow-up ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 10, 2008)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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)
Official Title  ICMJE 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
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.

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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non-Small Cell Lung Cancer
Intervention  ICMJE
  • Drug: cisplatin + docetaxel
    docetaxel 75 mg/m2 d1 and cisplatin 75mg/m2 d1 (q 3wks for 4 cycles)
    Other Names:
    • Platinol
    • Taxotere
  • 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
Study Arms  ICMJE
  • Active Comparator: Arm A
    Chemotherapy without LMWH
    Intervention: Drug: cisplatin + docetaxel
  • Experimental: Arm B
    Chemotherapy with LMWH
    Intervention: Drug: cisplatin + docetaxel + enoxaparin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 27, 2013)
104
Original Estimated Enrollment  ICMJE
 (submitted: October 10, 2008)
360
Actual Study Completion Date  ICMJE October 2012
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00771563
Other Study ID Numbers  ICMJE TOGA 0601
EudraCT 2007-007696-16
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ethisch Comité UZ Antwerpen, University Hospital, Antwerp
Study Sponsor  ICMJE University Hospital, Antwerp
Collaborators  ICMJE Universiteit Antwerpen
Investigators  ICMJE
Principal Investigator: Paul R Germonpre, MD PhD Universiteit Antwerpen
PRS Account University Hospital, Antwerp
Verification Date June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP