Clinical trial NCT00771563: 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: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non-Small Cell Lung Cancer
Keywords: Non-Small Cell Lung Cancer
chemotherapy
Low Molecular Weight Heparin
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
Collaborators: name: Universiteit Antwerpen
First posted: 2008-10-13
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Progression Free Survival
timeFrame: during chemotherapy and follow-up
Secondary outcomes:
measure: Symptom control evaluated with the Lung Cancer Symptoms Scale (LCSS)
timeFrame: during chemotherapy and follow-up
measure: Overall Survival
timeFrame: during chemotherapy and follow-up
measure: Best Overall Response
timeFrame: during chemotherapy and follow-up
measure: Incidence of total documented thromboembolic and hemorrhagic events
timeFrame: during chemotherapy and follow-up
measure: Overall safety and tolerability
timeFrame: during chemotherapy and follow-up
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: University Hospital Antwerp
state: Antwerp
city: Liège
country: Belgium
facility: Centre Hospitalier Universitaire Sart Tilman
Study officials:
affiliation: Universiteit Antwerpen
name: Paul R Germonpre, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rutjes AW, Porreca E, Candeloro M, Valeriani E, Di Nisio M. Primary prophylaxis for venous thromboembolism in ambulatory cancer patients receiving chemotherapy. Cochrane Database Syst Rev. 2020 Dec 18;12(12):CD008500. doi: 10.1002/14651858.CD008500.pub5.