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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)

Primary Purpose

Non-Small Cell Lung Cancer

Status

Completed

Phase

Phase 3

Locations

Belgium

Study Type

Interventional

Intervention

cisplatin + docetaxel

cisplatin + docetaxel + enoxaparin

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Cancer focused on measuring Non-Small Cell Lung Cancer, chemotherapy, Low Molecular Weight Heparin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University Hospital Antwerp
Centre Hospitalier Universitaire Sart Tilman

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm A

Arm B

Arm Description

Chemotherapy without LMWH

Chemotherapy with LMWH

Outcomes

Primary Outcome Measures

Progression Free Survival

Secondary Outcome Measures

Symptom control evaluated with the Lung Cancer Symptoms Scale (LCSS)

Overall Survival

Best Overall Response

Incidence of total documented thromboembolic and hemorrhagic events

Overall safety and tolerability

Full Information

NCT ID

NCT00771563

First Posted

October 10, 2008

Last Updated

June 27, 2013

Sponsor

University Hospital, Antwerp

Collaborators

Universiteit Antwerpen

1. Study Identification

Unique Protocol Identification Number

NCT00771563

Brief Title

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)

Acronym

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

2. Study Status

Record Verification Date

June 2013

Overall Recruitment Status

Completed

Study Start Date

June 2008 (undefined)

Primary Completion Date

October 2012 (Actual)

Study Completion Date

October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University Hospital, Antwerp

Collaborators

Universiteit Antwerpen

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-Small Cell Lung Cancer

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

104 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm A

Arm Type

Active Comparator

Arm Description

Chemotherapy without LMWH

Arm Title

Arm B

Arm Type

Experimental

Arm Description

Chemotherapy with LMWH

Intervention Type

Drug

Intervention Name(s)

cisplatin + docetaxel

Other Intervention Name(s)

Platinol, Taxotere

Intervention Description

docetaxel 75 mg/m2 d1 and cisplatin 75mg/m2 d1 (q 3wks for 4 cycles)

Intervention Type

Drug

Intervention Name(s)

cisplatin + docetaxel + enoxaparin

Other Intervention Name(s)

Platinol, Taxotere, Clexane, LMWH

Intervention Description

cisplatin 75 mg/m2 d1 and docetaxel 75 mg/m2 d1 (q 3 wks for 4 cycles) + daily enoxaparin 1mg/kg/d sc

Primary Outcome Measure Information:

Title

Progression Free Survival

Time Frame