Clinical trial NCT00717938: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Small Cell Lung Cancer
Lead sponsor: Lund University Hospital
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2008-07-18
Enrollment: 390
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Significant increase of overall survival
timeFrame: At follow up 1 year after treatment
Secondary outcomes:
measure: Toxicity
timeFrame: During treatment
Other outcomes:
Locations:
city: Gävle
country: Sweden
facility: Gävle hospital
city: Göteborg
country: Sweden
facility: Sahlgrenska University Hospital
city: Helsingborg
country: Sweden
facility: Helsingborg Hospital
city: Jönköping
country: Sweden
facility: Ryhov Hospital, Jönköping
city: Karlskrona
country: Sweden
facility: Blekinge Hospital
city: Karlstad
country: Sweden
facility: Central Hospital
city: Kristianstad
country: Sweden
facility: Central Hospital
city: Linköping
country: Sweden
facility: University Hospital Linköping
city: Lund
country: Sweden
facility: University Hospital Department of Respiratory Medicine
city: Malmö
country: Sweden
facility: University Hospital MAS
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
city: Umeå
country: Sweden
facility: Norrlands University Hospital
city: Uppsala
country: Sweden
facility: Akademiska hospital Uppsala
city: Växjö
country: Sweden
facility: Central Hospital
city: Ystad
country: Sweden
facility: Ystad hospital
city: Örebro
country: Sweden
facility: University Hospital, Örebro
Study officials:
affiliation: University Hospital, Lund
name: Lars Ek, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Lund
name: Jan Sundberg, RN
role: STUDY_DIRECTOR
References:
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.