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

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

Tracking Information

• First Submitted Date: July 16, 2008
• First Posted Date: July 18, 2008
• Last Update Posted Date: August 25, 2017
• Study Start Date: June 2008
• Actual Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: July 16, 2008): Significant increase of overall survival [ Time Frame: At follow up 1 year after treatment ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: July 16, 2008): Toxicity [ Time Frame: During treatment ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study of Standard Treatment +/- Enoxaparin in Small Cell Lung Cancer
• Official Title: 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Small Cell Lung Cancer

Intervention

• 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

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 16, 2008): 390
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: May 2017
• Actual Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Sweden

Administrative Information

• NCT Number: NCT00717938
• Other Study ID Numbers: EudraCT number 2007-006033-14
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Lund University Hospital
• Original Responsible Party: Lars Ek, University Hospital Lund, Department of Respiratory Medicine
• Current Study Sponsor: Lund University Hospital
• Original Study Sponsor: Same as current
• Collaborators: Sanofi

Investigators

• 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