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

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Lund University Hospital
ClinicalTrials.gov Identifier:
NCT00717938
First received: July 16, 2008
Last updated: August 24, 2017
Last verified: September 2016
  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
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

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 ]

Secondary Outcome Measures:
  • Toxicity [ Time Frame: During treatment ]

Enrollment: 390
Study Start Date: June 2008
Study Completion Date: May 2017
Primary Completion Date: May 2017 (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   (Adult, Senior)
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
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

Locations
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
Principal Investigator: Lars Ek, MD University Hospital, Lund
Study Director: Jan Sundberg, RN University Hospital, Lund
  More Information

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: August 24, 2017

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
Carboplatin
Etoposide
Cisplatin
Topoisomerase Inhibitors
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 21, 2017