Status:
COMPLETED
A Study of Standard Treatment +/- Enoxaparin in Small Cell Lung Cancer
Lead Sponsor:
Lund University Hospital
Collaborating Sponsors:
Sanofi
Conditions:
Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The endpoint is to investigate if the addition of low molecular heparin - enoxaparin, will result in a significant increase of overall survival in patients with small cell lung cancer, receiving stand...
Detailed Description
Chemotherapy will be given in accordance with local or regional guidelines but shall include a platinum drug + any topoisomerase inhibitor. Within these limits the study will accept different local va...
Eligibility Criteria
Inclusion
- Histologically or cytologically verified SCLC, all stages
- WHO performance status 0, 1, 2 or 3
- Age 18 years or older
- Intention and feasibility to treat with chemotherapy consisting of platinum + topoisomerase inhibitor.
- Platelets \>100 x109 /L
- Signed informed consent
- PK (prothrombin complex) INR and APTT within normal ranges.
Exclusion
- Prior systemic chemotherapy for lung cancer.
- Concomitant anticoagulation treatment, except for ASA or clopidogrel
- Active overt bleeding of clinical importance or at high risk (e.g. earlier observed haemorrhage in a brain metastasis, severe coagulopathy as haemophilia, severe liver dysfunction with impaired coagulation, acute peptic ulcer, and within the last 3 months suffered from intracranial haemorrhage, or surgery in the central nervous system).
- Any other known contraindication for enoxaparine ( e.g. Hypersensitivity against enoxaparine and its derivatives).
- Pregnancy or breast-feeding
- Fertile women not using effective contraceptives or men who do not agree to use effective contraception during the treatment period.
- Treatment with any other investigational agent, or participation in any other clinical trial.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2017
Estimated Enrollment :
390 Patients enrolled
Trial Details
Trial ID
NCT00717938
Start Date
June 1 2008
End Date
May 1 2017
Last Update
August 25 2017
Active Locations (16)
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1
Gävle hospital
Gävle, Sweden, 801 87
2
Sahlgrenska University Hospital
Gothenburg, Sweden, 413 45
3
Helsingborg Hospital
Helsingborg, Sweden
4
Ryhov Hospital, Jönköping
Jönköping, Sweden