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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Other | 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. |
|
| B | Experimental | 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. In addition to this, subjects will receive daily subcutaneous injections of enoxaparin during chemotherapy treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cisplatinum or carboplatin and e.g.etoposide. | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Significant increase of overall survival | At follow up 1 year after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity | During treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lars Ek, MD | University Hospital, Lund | Principal Investigator |
| Jan Sundberg, RN | University Hospital, Lund | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gävle hospital | Gävle | 801 87 | Sweden | |||
| Sahlgrenska University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29106448 | Derived | Ek L, Gezelius E, Bergman B, Bendahl PO, Anderson H, Sundberg J, Wallberg M, Falkmer U, Verma S, Belting M; Swedish Lung Cancer Study Group (SLUSG). Randomized phase III trial of low-molecular-weight heparin enoxaparin in addition to standard treatment in small-cell lung cancer: the RASTEN trial. Ann Oncol. 2018 Feb 1;29(2):398-404. doi: 10.1093/annonc/mdx716. |
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|
|
| cisplatinum or carboplatin and e.g.etoposide+enoxaparin | Drug | 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. |
|
|
| Gothenburg |
| 413 45 |
| Sweden |
| Helsingborg Hospital | Helsingborg | Sweden |
| Ryhov Hospital, Jönköping | Jönköping | Sweden |
| Blekinge Hospital | Karlskrona | 371 85 | Sweden |
| Central Hospital | Karlstad | 651 85 | Sweden |
| Central Hospital | Kristianstad | 291 85 | Sweden |
| University Hospital Linköping | Linköping | 581 85 | Sweden |
| University Hospital Department of Respiratory Medicine | Lund | 221 85 | Sweden |
| University Hospital MAS | Malmö | 205 02 | Sweden |
| University Hospital, Örebro | Örebro | Sweden |
| Karolinska University Hospital | Stockholm | 171 76 | Sweden |
| Norrlands University Hospital | Umeå | Sweden |
| Akademiska hospital Uppsala | Uppsala | 751 85 | Sweden |
| Central Hospital | Vaxjo | 351 85 | Sweden |
| Ystad hospital | Ystad | 271 82 | Sweden |
| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D002945 | Cisplatin |
| D016190 | Carboplatin |
| D005047 | Etoposide |
| D017984 | Enoxaparin |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D006495 | Heparin, Low-Molecular-Weight |
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
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