Clinical trial · Interventional
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
NCT00717938CI-TRIAL-00029283RASTENcompletedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Small Cell Lung Cancer | Lung Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatinum or carboplatin and e.g.etoposide. | Drug | — | UNRESOLVED |
| cisplatinum or carboplatin and e.g.etoposide+enoxaparin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- A
- description
- 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.
- interventionNames
- Drug: cisplatinum or carboplatin and e.g.etoposide.
- type
- EXPERIMENTAL
- label
- B
- description
- 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.
- interventionNames
- Drug: cisplatinum or carboplatin and e.g.etoposide+enoxaparin
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDEk 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. PMID 29106448