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

Primary Purpose

Small Cell Lung Cancer

Status
Completed
Phase
Phase 3
Locations
Sweden
Study Type
Interventional
Intervention
cisplatinum or carboplatin and e.g.etoposide.
cisplatinum or carboplatin and e.g.etoposide+enoxaparin
Sponsored by
Lund University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Gävle hospital
  • Sahlgrenska University Hospital
  • Helsingborg Hospital
  • Ryhov Hospital, Jönköping
  • Blekinge Hospital
  • Central Hospital
  • Central Hospital
  • University Hospital Linköping
  • University Hospital Department of Respiratory Medicine
  • University Hospital MAS
  • Karolinska University Hospital
  • Norrlands University Hospital
  • Akademiska hospital Uppsala
  • Central Hospital
  • Ystad hospital
  • University Hospital, Örebro

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

A

B

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Significant increase of overall survival

Secondary Outcome Measures

Toxicity

Full Information

First Posted
July 16, 2008
Last Updated
August 24, 2017
Sponsor
Lund University Hospital
Collaborators
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00717938
Brief Title
A Study of Standard Treatment +/- Enoxaparin in Small Cell Lung Cancer
Acronym
RASTEN
Official Title
A Randomized Phase III Study of Standard Treatment +/- Enoxaparin in Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lund University Hospital
Collaborators
Sanofi

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
390 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Other
Arm Description
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.
Arm Title
B
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
cisplatinum or carboplatin and e.g.etoposide.
Other Intervention Name(s)
cisplatinum, carboplatin, etoposide
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
cisplatinum or carboplatin and e.g.etoposide+enoxaparin
Other Intervention Name(s)
cisplatinum, carboplatin, etoposide, enoxaparin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Significant increase of overall survival
Time Frame
At follow up 1 year after treatment
Secondary Outcome Measure Information:
Title
Toxicity
Time Frame
During treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically verified SCLC, all stages WHO performance status 0, 1, 2 or 3 Age 18 years or older Intention and feasibility to treat with chemotherapy consisting of platinum + topoisomerase inhibitor. Platelets >100 x109 /L Signed informed consent PK (prothrombin complex) INR and APTT within normal ranges. Exclusion Criteria: Prior systemic chemotherapy for lung cancer. Concomitant anticoagulation treatment, except for ASA or clopidogrel 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). Any other known contraindication for enoxaparine ( e.g. Hypersensitivity against enoxaparine and its derivatives). Pregnancy or breast-feeding Fertile women not using effective contraceptives or men who do not agree to use effective contraception during the treatment period. Treatment with any other investigational agent, or participation in any other clinical trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars Ek, MD
Organizational Affiliation
University Hospital, Lund
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jan Sundberg, RN
Organizational Affiliation
University Hospital, Lund
Official's Role
Study Director
Facility Information:
Facility Name
Gävle hospital
City
Gävle
ZIP/Postal Code
801 87
Country
Sweden
Facility Name
Sahlgrenska University Hospital
City
Göteborg
ZIP/Postal Code
413 45
Country
Sweden
Facility Name
Helsingborg Hospital
City
Helsingborg
Country
Sweden
Facility Name
Ryhov Hospital, Jönköping
City
Jönköping
Country
Sweden
Facility Name
Blekinge Hospital
City
Karlskrona
ZIP/Postal Code
371 85
Country
Sweden
Facility Name
Central Hospital
City
Karlstad
ZIP/Postal Code
651 85
Country
Sweden
Facility Name
Central Hospital
City
Kristianstad
ZIP/Postal Code
291 85
Country
Sweden
Facility Name
University Hospital Linköping
City
Linköping
ZIP/Postal Code
581 85
Country
Sweden
Facility Name
University Hospital Department of Respiratory Medicine
City
Lund
ZIP/Postal Code
221 85
Country
Sweden
Facility Name
University Hospital MAS
City
Malmö
ZIP/Postal Code
205 02
Country
Sweden
Facility Name
Karolinska University Hospital
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden
Facility Name
Norrlands University Hospital
City
Umeå
Country
Sweden
Facility Name
Akademiska hospital Uppsala
City
Uppsala
ZIP/Postal Code
751 85
Country
Sweden
Facility Name
Central Hospital
City
Växjö
ZIP/Postal Code
351 85
Country
Sweden
Facility Name
Ystad hospital
City
Ystad
ZIP/Postal Code
271 82
Country
Sweden
Facility Name
University Hospital, Örebro
City
Örebro
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
29106448
Citation
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.
Results Reference
derived

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

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