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

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ClinicalTrials.gov Identifier: NCT00717938
Recruitment Status : Completed
First Posted : July 18, 2008
Last Update Posted : August 25, 2017
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Lund University Hospital

Tracking Information
First Submitted Date  ICMJE July 16, 2008
First Posted Date  ICMJE July 18, 2008
Last Update Posted Date August 25, 2017
Study Start Date  ICMJE June 2008
Actual Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 16, 2008)
Significant increase of overall survival [ Time Frame: At follow up 1 year after treatment ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00717938 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 16, 2008)
Toxicity [ Time Frame: During treatment ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Standard Treatment +/- Enoxaparin in Small Cell Lung Cancer
Official Title  ICMJE A Randomized Phase III Study of Standard Treatment +/- Enoxaparin in Small Cell Lung Cancer
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Small Cell Lung Cancer
Intervention  ICMJE
  • 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.
    Other Names:
    • cisplatinum
    • carboplatin
    • etoposide
  • 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.
    Other Names:
    • cisplatinum
    • carboplatin
    • etoposide
    • enoxaparin
Study Arms  ICMJE
  • A
    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.
    Intervention: Drug: cisplatinum or carboplatin and e.g.etoposide.
  • Experimental: B
    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.
    Intervention: Drug: cisplatinum or carboplatin and e.g.etoposide+enoxaparin
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 16, 2008)
390
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2017
Actual Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00717938
Other Study ID Numbers  ICMJE EudraCT number 2007-006033-14
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lund University Hospital
Study Sponsor  ICMJE Lund University Hospital
Collaborators  ICMJE Sanofi
Investigators  ICMJE
Principal Investigator: Lars Ek, MD University Hospital, Lund
Study Director: Jan Sundberg, RN University Hospital, Lund
PRS Account Lund University Hospital
Verification Date September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP