Small Cell Lung CancerPhase 3RASTENNCT00717938
A Study of Standard Treatment +/- Enoxaparin in Small Cell Lung Cancer
A Phase 3 study testing cisplatinum or carboplatin and e.g.etoposide. and cisplatinum or carboplatin and e.g.etoposide+enoxaparin in people with Small Cell Lung Cancer, run by Lund University Hospital at 16 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Cell Lung Cancer
- What is being tested?
- cisplatinum or carboplatin and e.g.etoposide. and cisplatinum or carboplatin and e.g.etoposide+enoxaparin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 390 participants
- Where
- 16 sitesSweden
- Study dates
- Jun 2008to May 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
Sweden16 sites
Gävle hospital
Gävle, 801 87
Sahlgrenska University Hospital
Gothenburg, 413 45
Helsingborg Hospital
Helsingborg
Ryhov Hospital, Jönköping
Jönköping
Blekinge Hospital
Karlskrona, 371 85
Central Hospital
Karlstad, 651 85
Central Hospital
Kristianstad, 291 85
University Hospital Linköping
Linköping, 581 85
University Hospital Department of Respiratory Medicine
Lund, 221 85
University Hospital MAS
Malmö, 205 02
University Hospital, Örebro
Örebro
Karolinska University Hospital
Stockholm, 171 76
Norrlands University Hospital
Umeå
Akademiska hospital Uppsala
Uppsala, 751 85
Central Hospital
Vaxjo, 351 85
Ystad hospital
Ystad, 271 82
About this study
Official title: 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.
Read the 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.
- Conditions
- Small Cell Lung Cancer
- Being tested
- cisplatinum or carboplatin and e.g.etoposide., cisplatinum or carboplatin and e.g.etoposide+enoxaparin
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cisplatinum or carboplatin and e.g.etoposide.Drug
Also called cisplatinum, carboplatin, 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.
cisplatinum or carboplatin and e.g.etoposide+enoxaparinDrug
Also called cisplatinum, carboplatin, 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.
| Study group | Role | What they receive |
|---|---|---|
| A | Other | 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. Receives: Drug: cisplatinum or carboplatin and e.g.etoposide. |
| B | Experimental | 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. Receives: Drug: cisplatinum or carboplatin and e.g.etoposide+enoxaparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Significant increase of overall survival
Measured: At follow up 1 year after treatment
Secondary outcomes (1)
Toxicity
Measured: During treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2008 (estimated)
- Study startJun 2008
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 390 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Sponsor
- Investigators
- Lars Ek, MD, Principal investigator, University Hospital, LundJan Sundberg, RN, Study director, University Hospital, Lund
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00717938
- Sponsor's protocol ID
- EudraCT number 2007-006033-14
- Acronym
- RASTEN
- Status last verified
- Sep 2016
- First submitted
- 16 Jul 2008
- Last updated
- 25 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 29106448
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase III Study of Standard Treatment +/- Enoxaparin in Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00717938
- Acronym / sponsor ID
- RASTEN / EudraCT number 2007-006033-14
- Conditions
- Small Cell Lung Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 390 participants (actual)
- Lead sponsor
- Lund University HospitalUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- Jun 2008
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 18 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Other | 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. |
| B | Experimental | Drug: cisplatinum or carboplatin and e.g.etoposide+enoxaparinStandard 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cisplatinum or carboplatin and e.g.etoposide.Also: cisplatinum, carboplatin, etoposideStandard 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. | Drug | A |
| cisplatinum or carboplatin and e.g.etoposide+enoxaparinAlso: cisplatinum, carboplatin, etoposide, enoxaparinStandard 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. | Drug | B |
Primary outcome
Significant increase of overall survival
Time frame: At follow up 1 year after treatment
1 secondary outcome
Toxicity
Time frame: During treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2017.
- Derived from this study: PubMed 29106448Ek 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lars Ek, MD principal investigator
University Hospital, Lund
Jan Sundberg, RN study director
University Hospital, Lund
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing cisplatinum or carboplatin and e.g.etoposide. and cisplatinum or carboplatin and e.g.etoposide+enoxaparin in people with Small Cell Lung Cancer, run by Lund University Hospital at 16 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Significant increase of overall survival (time frame: At follow up 1 year after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00717938, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2017.