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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Lund University Hospital
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Lund University Hospital
ClinicalTrials.gov Identifier:
NCT00717938
First received: July 16, 2008
Last updated: April 25, 2014
Last verified: April 2014
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Phase III Study of Standard Treatment +/- Enoxaparin in Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Lund University Hospital:

Primary Outcome Measures:
  • Significant increase of overall survival [ Time Frame: At follow up 1 year after treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Toxicity [ Time Frame: During treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 390
Study Start Date: June 2008
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00717938

Contacts
Contact: Lars Ek, MD +46 46 17 73 40 lars.ek@skane.se
Contact: Jan Sundberg, RN +46 46 17 70 34 jan.sundberg@skane.se

Locations
Sweden
Gävle hospital Recruiting
Gävle, Sweden, 801 87
Contact: Hirsh Koyi, MD       hirsh.koyi@lg.se   
Principal Investigator: Hirsh Koyi, MD         
Sahlgrenska University Hospital Recruiting
Göteborg, Sweden, 413 45
Contact: Bengt Bergman, MD       bengt.bergman@lungall.gu.se   
Principal Investigator: Bengt Bergman, MD         
Helsingborg Hospital Recruiting
Helsingborg, Sweden
Contact: Mats Lagerstedt, MD       mats.lagerstedt@skane.se   
Principal Investigator: Mats Lagerstedt, MD         
Ryhov Hospital, Jönköping Recruiting
Jönköping, Sweden
Contact: Magnus Kentson, MD       magnus.kentson@lj.se   
Principal Investigator: Magnus Kentson, MD         
Blekinge Hospital Recruiting
Karlskrona, Sweden, 371 85
Contact: Bengt Dahlander, MD       bengt.dahlander@ltblekinge.se   
Principal Investigator: Bengt Dahlander, MD         
Central Hospital Recruiting
Karlstad, Sweden, 651 85
Contact: Martin Rydin, MD       martin.rydin@liv.se   
Principal Investigator: Martin Rydin, MD         
Central Hospital Recruiting
Kristianstad, Sweden, 291 85
Contact: Inga Svensson, MD       inga.n.svensson@skane.se   
Principal Investigator: Inga Svensson, MD         
University Hospital Linköping Recruiting
Linköping, Sweden, 581 85
Contact: Christer Cederholm, MD       christer.cederholm@lio.se   
Principal Investigator: Christer Cederholm, MD         
University Hospital Department of Respiratory Medicine Recruiting
Lund, Sweden, 221 85
Contact: Lars Ek, MD    +46 46 17 7340    lars.ek@skane.se   
Contact: Jan Sundberg, RN    +46 46 17 70 34    jan.sundberg@skane.se   
Principal Investigator: Lars EK, MD         
University Hospital MAS Recruiting
Malmö, Sweden, 205 02
Contact: Jaroslaw Kosieradzki, MD       jaroslaw.kosieradzki@skane.se   
Principal Investigator: Jaroslaw Kosieradzki, MD         
Karolinska University Hospital Recruiting
Stockholm, Sweden, 171 76
Contact: Karl-Gustav Kölbeck, MD       karl.kolbeck@karolinska.se   
Principal Investigator: Karl-Gustav Kölbeck, MD         
Norrlands University Hospital Recruiting
Umeå, Sweden
Contact: Annelie Behndig, MD       annelie.behndig@lung.umu.se   
Principal Investigator: Annelie Behndig, MD         
Akademiska hospital Uppsala Recruiting
Uppsala, Sweden, 751 85
Contact: Kristina Lamberg, MD       kristina.lamberg@akademiska.se   
Principal Investigator: Kristina Lamberg, MD         
Central Hospital Recruiting
Växjö, Sweden, 351 85
Contact: Gunilla Lindström, MD       gunilla.lindstrom@ltkronoberg.se   
Principal Investigator: Gunilla Lindström, MD         
Ystad hospital Recruiting
Ystad, Sweden, 271 82
Contact: Kerstin Andersson, MD       kerstin.e.andersson@skane.se   
Principal Investigator: Kerstin Andersson, MD         
University Hospital, Örebro Recruiting
Örebro, Sweden
Contact: Lars Thaning, MD       lars.thaning@orebroll.se   
Principal Investigator: Lars Thaning, MD         
Sponsors and Collaborators
Lund University Hospital
Sanofi
Investigators
Principal Investigator: Lars Ek, MD University Hospital, Lund
Study Director: Jan Sundberg, RN University Hospital, Lund
  More Information

No publications provided

Responsible Party: Lund University Hospital
ClinicalTrials.gov Identifier: NCT00717938     History of Changes
Other Study ID Numbers: EudraCT number 2007-006033-14
Study First Received: July 16, 2008
Last Updated: April 25, 2014
Health Authority: Sweden: Medical Products Agency

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Etoposide phosphate
Cisplatin
Etoposide
Carboplatin
Enoxaparin
Topoisomerase Inhibitors
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Anticoagulants
Hematologic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 28, 2014