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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Non-Small Cell Lung Cancer

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival

Outcome Time Frame:

during chemotherapy and follow-up

Safety Issue:

No

Principal Investigator

Paul R Germonpre, MD PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Universiteit Antwerpen

Authority:

Belgium: Federal Agency for Medicinal Products and Health Products

Study ID:

TOGA 0601

NCT ID:

NCT00771563

Start Date:

June 2008

Completion Date:

October 2012

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Non-Small Cell Lung Cancer
  • chemotherapy
  • Low Molecular Weight Heparin
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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