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)
This study is ongoing, but not recruiting participants.
Sponsor:
University Hospital, Antwerp
Collaborator:
Universiteit Antwerpen
Information provided by (Responsible Party):
Ethisch Comité UZ Antwerpen, University Hospital, Antwerp
ClinicalTrials.gov Identifier:
NCT00771563
First received: October 10, 2008
Last updated: January 16, 2012
Last verified: January 2012
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Purpose
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 Endpoint Classification: Safety/Efficacy Study 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 University Hospital, Antwerp:
Primary Outcome Measures:
- Progression Free Survival [ Time Frame: during chemotherapy and follow-up ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Symptom control evaluated with the Lung Cancer Symptoms Scale (LCSS) [ Time Frame: during chemotherapy and follow-up ] [ Designated as safety issue: No ]
- Overall Survival [ Time Frame: during chemotherapy and follow-up ] [ Designated as safety issue: No ]
- Best Overall Response [ Time Frame: during chemotherapy and follow-up ] [ Designated as safety issue: No ]
- Incidence of total documented thromboembolic and hemorrhagic events [ Time Frame: during chemotherapy and follow-up ] [ Designated as safety issue: Yes ]
- Overall safety and tolerability [ Time Frame: during chemotherapy and follow-up ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 360 |
| Study Start Date: | June 2008 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 2013 (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:
|
|
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:
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00771563
Locations
| Belgium | |
| University Hospital Antwerp | |
| Edegem, Antwerp, Belgium, 2650 | |
| Centre Hospitalier Universitaire Sart Tilman | |
| Liège, Belgium, 4000 | |
Sponsors and Collaborators
University Hospital, Antwerp
Universiteit Antwerpen
Investigators
| Principal Investigator: | Paul R Germonpre, MD PhD | Universiteit Antwerpen |
More Information
No publications provided
| Responsible Party: | Ethisch Comité UZ Antwerpen, Thoracale Oncologie Groep Antwerpen, University Hospital, Antwerp |
| ClinicalTrials.gov Identifier: | NCT00771563 History of Changes |
| Other Study ID Numbers: | TOGA 0601, EudraCT 2007-007696-16 |
| Study First Received: | October 10, 2008 |
| Last Updated: | January 16, 2012 |
| Health Authority: | Belgium: Federal Agency for Medicinal Products and Health Products |
Keywords provided by University Hospital, Antwerp:
|
Non-Small Cell Lung Cancer chemotherapy Low Molecular Weight Heparin |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Docetaxel Cisplatin Heparin Heparin, Low-Molecular-Weight |
Dalteparin Enoxaparin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Anticoagulants Hematologic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 19, 2013