NCT00717938

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 390 (actual)
• Sponsor: Lund University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 standard chemotherapy.

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 variants as long as each centre remains consistent to its declared standard chemotherapy regimen. The recommended regimen is carboplatin or cisplatin plus etoposide q3 weeks for 4 cycles but up to 6 cycles is allowed. Local dosages and dose reduction schedules will be used.

Conditions

• Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	cisplatinum or carboplatin and e.g.etoposide.	Standard chemotherapy treatment for patients with small cell lung cancer. Chemotherapy regimen contains a platinum drug and a topoisomerase inhibitor. Numbers of cycles 4-6 according to local variants. Used drugs=cisplatinum or carboplatin and e.g.etoposide. Treatment will be given every three weeks for 4-6 cycles according to local variants.
DRUG	cisplatinum or carboplatin and e.g.etoposide+enoxaparin	Standard chemotherapy treatment for patients with small cell lung cancer. Chemotherapy regimen contains a platinum drug and a topoisomerase inhibitor. Numbers of cycles 4-6 according to local variants. In addition to this, subjects will receive daily subcutaneous injections of enoxaparin during chemotherapy treatment.

Timeline

• Start date: 2008-06-01
• Primary completion: 2017-05-01
• Completion: 2017-05-01
• First posted: 2008-07-18
• Last updated: 2017-08-25

Locations

16 sites across 1 country: Sweden