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 - SYRINGES

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-007696-16-BE

Enrollment

Unknown

Registered

2008-03-12

Start date

2008-06-02

Completion date

Unknown

Last updated

2017-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non Small Cell Lung Cancer MedDRA version: 9.1 Level: LLT Classification code 10025054 Term: Lung cancer non-small cell stage IIIB MedDRA version: 9.1 Level: LLT Classification code 10025055 Term: Lung cancer non-small cell stage IV

Interventions

Product Name: docetaxel Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: docetaxel CAS Number: 114977-28-5 Concentration unit: mg/ml milligram(s)/millilitre Concentratio

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Locally advanced or metastatic NSCLC (stage IIIB-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 (KPS 100-70) -Age =18 years. -Adequate haematological, renal and liver function -Written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: -Previous chemotherapy for NSCLC -Brain metastasis -history of cerebral haemorrhage, neurosurgery within 3 previous months or Surgery within the past 6 weeks -Indication for anticoagulant therapy or thrombolytic therapy -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 do not permit study treatment or follow up required to comply with the study protocol

Design outcomes

Primary

Measure	Time frame
Main Objective: The aim of this study is to determine the potential beneficial antitumoral effect of enoxaparin in patients with advanced NSCLC treated with cisplatin-based chemotherapy. Primary endpoint: Progression Free Survival (PFS) ;Secondary Objective: Main secondary objective: Symptom control evaluated with the Lung Cancer Symptoms Scale (LCSS) Other secondary objectives: -Overall Survival (OS) -Best Overall Response (OR) -Incidence of total documented thromboembolic and hemorrhagic events -Overall safety and tolerability ;Primary end point(s): Progression Free Survival (PFS)	—

Measure

Time frame

Main Objective: The aim of this study is to determine the potential beneficial antitumoral effect of enoxaparin in patients with advanced NSCLC treated with cisplatin-based chemotherapy. Primary endpoint: Progression Free Survival (PFS) ;Secondary Objective: Main secondary objective: Symptom control evaluated with the Lung Cancer Symptoms Scale (LCSS) Other secondary objectives: -Overall Survival (OS) -Best Overall Response (OR) -Incidence of total documented thromboembolic and hemorrhagic events -Overall safety and tolerability ;Primary end point(s): Progression Free Survival (PFS)

—

Countries

Belgium

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026