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

A Randomized Phase III Study of Standard Treatment +/- Enoxaparin in Small Cell Lung Cancer

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.

Study Overview

• Status: Completed
• Conditions: Small Cell Lung Cancer
• Intervention / Treatment: Drug: cisplatinum or carboplatin and e.g.etoposide.; Drug: cisplatinum or carboplatin and e.g.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.

• Study Type: Interventional
• Enrollment (Actual): 390
• Phase: Phase 3

Contacts and Locations

Study Locations

• Sweden
  • Gävle, Sweden, 801 87
    • Gävle Hospital
  • Göteborg, Sweden, 413 45
    • Sahlgrenska University Hospital
  • Helsingborg, Sweden
    • Helsingborg Hospital
  • Jönköping, Sweden
    • Ryhov Hospital, Jönköping
  • Karlskrona, Sweden, 371 85
    • Blekinge Hospital
  • Karlstad, Sweden, 651 85
    • Central Hospital
  • Kristianstad, Sweden, 291 85
    • Central Hospital
  • Linköping, Sweden, 581 85
    • University Hospital Linköping
  • Lund, Sweden, 221 85
    • University Hospital Department of Respiratory Medicine
  • Malmö, Sweden, 205 02
    • University Hospital MAS
  • Stockholm, Sweden, 171 76
    • Karolinska University Hospital
  • Umeå, Sweden
    • Norrlands University Hospital
  • Uppsala, Sweden, 751 85
    • Akademiska Hospital Uppsala
  • Växjö, Sweden, 351 85
    • Central Hospital
  • Ystad, Sweden, 271 82
    • Ystad Hospital
  • Örebro, Sweden
    • University Hospital, Örebro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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: enoxaparin; cisplatinum; carboplatin; etoposide

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Significant increase of overall survival	At follow up 1 year after treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
Toxicity	During treatment

Collaborators and Investigators

• Sponsor: Lund University Hospital
• Collaborators: Sanofi
• Investigators: Principal Investigator: Lars Ek, MD, University Hospital, Lund; Study Director: Jan Sundberg, RN, University Hospital, Lund

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: July 16, 2008
• First Submitted That Met QC Criteria: July 16, 2008
• First Posted (Estimate): July 18, 2008

Study Record Updates

• Last Update Posted (Actual): August 25, 2017
• Last Update Submitted That Met QC Criteria: August 24, 2017
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Fibrinolytic Agents; Fibrin Modulating Agents; Antineoplastic Agents; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anticoagulants; Carboplatin; Etoposide; Etoposide phosphate; Cisplatin; Enoxaparin; Enoxaparin sodium
• Other Study ID Numbers: EudraCT number 2007-006033-14