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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Small Cell Lung Cancer Drug: cisplatinum or carboplatin and e.g.etoposide. Drug: cisplatinum or carboplatin and e.g.etoposide+enoxaparin Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 390 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase III Study of Standard Treatment +/- Enoxaparin in Small Cell Lung Cancer
Study Start Date : June 2008
Actual Primary Completion Date : May 2017
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arms and Interventions
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Arm Intervention/treatment
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.
 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
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.
 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


Outcome Measures
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Primary Outcome Measures :
  1. Significant increase of overall survival [ Time Frame: At follow up 1 year after treatment ]

Secondary Outcome Measures :
  1. Toxicity [ Time Frame: During treatment ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00717938


Locations
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Sweden
Gävle hospital
Gävle, Sweden, 801 87
Sahlgrenska University Hospital
Göteborg, Sweden, 413 45
Helsingborg Hospital
Helsingborg, Sweden
Ryhov Hospital, Jönköping
Jönköping, Sweden
Blekinge Hospital
Karlskrona, Sweden, 371 85
Central Hospital
Karlstad, Sweden, 651 85
Central Hospital
Kristianstad, Sweden, 291 85
University Hospital Linköping
Linköping, Sweden, 581 85
University Hospital Department of Respiratory Medicine
Lund, Sweden, 221 85
University Hospital MAS
Malmö, Sweden, 205 02
Karolinska University Hospital
Stockholm, Sweden, 171 76
Norrlands University Hospital
Umeå, Sweden
Akademiska hospital Uppsala
Uppsala, Sweden, 751 85
Central Hospital
Växjö, Sweden, 351 85
Ystad hospital
Ystad, Sweden, 271 82
University Hospital, Örebro
Örebro, Sweden
Sponsors and Collaborators
Lund University Hospital
Sanofi
Investigators
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Principal Investigator: Lars Ek, MD University Hospital, Lund
Study Director: Jan Sundberg, RN University Hospital, Lund
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Lund University Hospital
ClinicalTrials.gov Identifier: NCT00717938    
Other Study ID Numbers: EudraCT number 2007-006033-14
First Posted: July 18, 2008    Key Record Dates
Last Update Posted: August 25, 2017
Last Verified: September 2016
Additional relevant MeSH terms:
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Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Carboplatin
Etoposide
Etoposide phosphate
 Cisplatin
Enoxaparin
Enoxaparin sodium
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents