Non-Small Cell Lung CancerPhase 3SYRINGESNCT00771563
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)
A Phase 3 study testing cisplatin + docetaxel and cisplatin + docetaxel + enoxaparin in people with Non-Small Cell Lung Cancer, run by University Hospital, Antwerp at 2 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- cisplatin + docetaxel and cisplatin + docetaxel + enoxaparin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 2 sitesBelgium
- Study dates
- Jun 2008to Oct 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
University Hospital Antwerp
Edegem, Antwerp, 2650
Centre Hospitalier Universitaire Sart Tilman
Liège, Liège, 4000
About this study
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
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.
Read the 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.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- cisplatin + docetaxel, cisplatin + docetaxel + enoxaparin
- Keywords
- Non-Small Cell Lung Cancer, chemotherapy, Low Molecular Weight Heparin
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cisplatin + docetaxelDrug
Also called Platinol, Taxotere
docetaxel 75 mg/m2 d1 and cisplatin 75mg/m2 d1 (q 3wks for 4 cycles)
cisplatin + docetaxel + enoxaparinDrug
Also called Platinol, Taxotere, Clexane, LMWH
cisplatin 75 mg/m2 d1 and docetaxel 75 mg/m2 d1 (q 3 wks for 4 cycles) + daily enoxaparin 1mg/kg/d sc
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Active comparator | Chemotherapy without LMWH Receives: Drug: cisplatin + docetaxel |
| Arm B | Experimental | Chemotherapy with LMWH Receives: Drug: cisplatin + docetaxel + enoxaparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
Measured: during chemotherapy and follow-up
Secondary outcomes (5)
Symptom control evaluated with the Lung Cancer Symptoms Scale (LCSS)
Measured: during chemotherapy and follow-up
Overall Survival
Measured: during chemotherapy and follow-up
Best Overall Response
Measured: during chemotherapy and follow-up
Incidence of total documented thromboembolic and hemorrhagic events
Measured: during chemotherapy and follow-up
Overall safety and tolerability
Measured: during chemotherapy and follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2008 (estimated)
- Study startJun 2008
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Collaborators
- Universiteit Antwerpen
- Responsible party
- Principal investigator, Ethisch Comité UZ Antwerpen, University Hospital, Antwerp
- Investigators
- Paul R Germonpre, MD PhD, Principal investigator, Universiteit Antwerpen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00771563
- Sponsor's protocol ID
- TOGA 0601
- Other IDs
- EudraCT 2007-007696-16
- Acronym
- SYRINGES
- Status last verified
- Jun 2013
- First submitted
- 10 Oct 2008
- Last updated
- 28 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 33337539
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00771563
- Acronym / sponsor ID
- SYRINGES / TOGA 0601
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- Non-Small Cell Lung Cancer, chemotherapy, Low Molecular Weight Heparin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Collaborators
- Universiteit Antwerpen
- Study start
- Jun 2008
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 13 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Active comparator | Drug: cisplatin + docetaxelChemotherapy without LMWH |
| Arm B | Experimental | Drug: cisplatin + docetaxel + enoxaparinChemotherapy with LMWH |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cisplatin + docetaxelAlso: Platinol, Taxoteredocetaxel 75 mg/m2 d1 and cisplatin 75mg/m2 d1 (q 3wks for 4 cycles) | Drug | Arm A |
| cisplatin + docetaxel + enoxaparinAlso: Platinol, Taxotere, Clexane, LMWHcisplatin 75 mg/m2 d1 and docetaxel 75 mg/m2 d1 (q 3 wks for 4 cycles) + daily enoxaparin 1mg/kg/d sc | Drug | Arm B |
Primary outcome
Progression Free Survival
Time frame: during chemotherapy and follow-up
5 secondary outcomes
Symptom control evaluated with the Lung Cancer Symptoms Scale (LCSS)
Time frame: during chemotherapy and follow-up
Overall Survival
Time frame: during chemotherapy and follow-up
Best Overall Response
Time frame: during chemotherapy and follow-up
Incidence of total documented thromboembolic and hemorrhagic events
Time frame: during chemotherapy and follow-up
Overall safety and tolerability
Time frame: during chemotherapy and follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2013.
- Derived from this study: PubMed 33337539Rutjes 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul R Germonpre, MD PhD principal investigator
Universiteit Antwerpen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing cisplatin + docetaxel and cisplatin + docetaxel + enoxaparin in people with Non-Small Cell Lung Cancer, run by University Hospital, Antwerp at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (time frame: during chemotherapy and follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00771563, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2013.