A Study of Standard Treatment +/- Enoxaparin in Small Cell Lung Cancer
Information source: Lund University Hospital
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Small Cell Lung Cancer
Intervention: cisplatinum or carboplatin and e.g.etoposide. (Drug); cisplatinum or carboplatin and e.g.etoposide+enoxaparin (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Lund University Hospital Official(s) and/or principal investigator(s): Lars Ek, MD, Principal Investigator, Affiliation: University Hospital, Lund Jan Sundberg, RN, Study Director, Affiliation: University Hospital, Lund
Overall contact: Lars Ek, MD, Phone: +46 46 17 73 40, Email: lars.ek@skane.se
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.
Clinical Details
Official title: A Randomized Phase III Study of Standard Treatment +/- Enoxaparin in Small Cell Lung Cancer
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Significant increase of overall survival
Secondary outcome: Toxicity
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Lars Ek, MD, Phone: +46 46 17 73 40, Email: lars.ek@skane.se
Gävle hospital, Gävle 801 87, Sweden; Recruiting Hirsh Koyi, MD, Email: hirsh.koyi@lg.se Hirsh Koyi, MD, Principal Investigator
Sahlgrenska University Hospital, Göteborg 413 45, Sweden; Recruiting Bengt Bergman, MD, Email: bengt.bergman@lungall.gu.se Bengt Bergman, MD, Principal Investigator
Helsingborg Hospital, Helsingborg, Sweden; Recruiting Mats Lagerstedt, MD, Email: mats.lagerstedt@skane.se Mats Lagerstedt, MD, Principal Investigator
Ryhov Hospital, Jönköping, Jönköping, Sweden; Recruiting Magnus Kentson, MD, Email: magnus.kentson@lj.se Magnus Kentson, MD, Principal Investigator
Blekinge Hospital, Karlskrona 371 85, Sweden; Recruiting Bengt Dahlander, MD, Email: bengt.dahlander@ltblekinge.se Bengt Dahlander, MD, Principal Investigator
Central Hospital, Karlstad 651 85, Sweden; Recruiting Martin Rydin, MD, Email: martin.rydin@liv.se Martin Rydin, MD, Principal Investigator
Central Hospital, Kristianstad 291 85, Sweden; Recruiting Inga Svensson, MD, Email: inga.n.svensson@skane.se Inga Svensson, MD, Principal Investigator
University Hospital Linköping, Linköping 581 85, Sweden; Recruiting Christer Cederholm, MD, Email: christer.cederholm@lio.se Christer Cederholm, MD, Principal Investigator
University Hospital Department of Respiratory Medicine, Lund 221 85, Sweden; Recruiting Lars Ek, MD, Phone: +46 46 17 7340, Email: lars.ek@skane.se Jan Sundberg, RN, Phone: +46 46 17 70 34, Email: jan.sundberg@skane.se Lars EK, MD, Principal Investigator
University Hospital MAS, Malmö 205 02, Sweden; Recruiting Jaroslaw Kosieradzki, MD, Email: jaroslaw.kosieradzki@skane.se Jaroslaw Kosieradzki, MD, Principal Investigator
Karolinska University Hospital, Stockholm 171 76, Sweden; Recruiting Karl-Gustav Kölbeck, MD, Email: karl.kolbeck@karolinska.se Karl-Gustav Kölbeck, MD, Principal Investigator
Norrlands University Hospital, Umeå, Sweden; Recruiting Annelie Behndig, MD, Email: annelie.behndig@lung.umu.se Annelie Behndig, MD, Principal Investigator
Akademiska hospital Uppsala, Uppsala 751 85, Sweden; Recruiting Kristina Lamberg, MD, Email: kristina.lamberg@akademiska.se Kristina Lamberg, MD, Principal Investigator
Central Hospital, Växjö 351 85, Sweden; Recruiting Gunilla Lindström, MD, Email: gunilla.lindstrom@ltkronoberg.se Gunilla Lindström, MD, Principal Investigator
Ystad hospital, Ystad 271 82, Sweden; Recruiting Kerstin Andersson, MD, Email: kerstin.e.andersson@skane.se Kerstin Andersson, MD, Principal Investigator
University Hospital, Örebro, Örebro, Sweden; Recruiting Lars Thaning, MD, Email: lars.thaning@orebroll.se Lars Thaning, MD, Principal Investigator
Additional Information
Starting date: June 2008
Last updated: April 10, 2015
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