A Study of Standard Treatment +/- Enoxaparin in Small Cell Lung Cancer
RASTEN
A Randomized Phase III Study of Standard Treatment +/- Enoxaparin in Small Cell Lung Cancer
1 other identifier
interventional
390
1 country
16
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 standard chemotherapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2008
Longer than P75 for phase_3
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 16, 2008
CompletedFirst Posted
Study publicly available on registry
July 18, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2017
CompletedAugust 25, 2017
September 1, 2016
8.9 years
July 16, 2008
August 24, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Significant increase of overall survival
At follow up 1 year after treatment
Secondary Outcomes (1)
Toxicity
During treatment
Study Arms (2)
A
OTHERStandard 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
EXPERIMENTALStandard 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Lund University Hospitallead
- Sanoficollaborator
Study Sites (16)
Gävle hospital
Gävle, 801 87, Sweden
Sahlgrenska University Hospital
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
Malmo, 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
Related Publications (1)
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.
PMID: 29106448DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lars Ek, MD
University Hospital, Lund
- STUDY DIRECTOR
Jan Sundberg, RN
University Hospital, Lund
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 16, 2008
First Posted
July 18, 2008
Study Start
June 1, 2008
Primary Completion
May 1, 2017
Study Completion
May 1, 2017
Last Updated
August 25, 2017
Record last verified: 2016-09