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A Study of Standard Treatment +/- Enoxaparin in Small Cell Lung Cancer

CompletedPhase 3

Sponsor: Lund University Hospital

Conditions: Small Cell Lung Cancer

Interventions: cisplatinum or carboplatin and e.g.etoposide., cisplatinum or carboplatin and e.g.etoposide+enoxaparin

Countries: Sweden

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 standard chemotherapy.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

1. Histologically or cytologically verified SCLC, all stages
2. WHO performance status 0, 1, 2 or 3
3. Age 18 years or older
4. Intention and feasibility to treat with chemotherapy consisting of platinum + topoisomerase inhibitor.
5. Platelets \>100 x109 /L
6. Signed informed consent
7. PK (prothrombin complex) INR and APTT within normal ranges.

Exclusion Criteria:

1. Prior systemic chemotherapy for lung cancer.
2. Concomitant anticoagulation treatment, except for ASA or clopidogrel
3. 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).
4. Any other known contraindication for enoxaparine ( e.g. Hypersensitivity against enoxaparine and its derivatives).
5. Pregnancy or breast-feeding
6. Fertile women not using effective contraceptives or men who do not agree to use effective contraception during the treatment period.
7. Treatment with any other investigational agent, or participation in any other clinical trial.

Locations (16)

Gävle, Sweden
Gothenburg, Sweden
Helsingborg, Sweden
Jönköping, Sweden
Karlskrona, Sweden
Karlstad, Sweden
Kristianstad, Sweden
Linköping, Sweden
Lund, Sweden
Malmö, Sweden
Örebro, Sweden
Stockholm, Sweden
Umeå, Sweden
Uppsala, Sweden
Vaxjo, Sweden
Ystad, Sweden