A randomized phase III study of standard treatment +/- enoxaparin in small cell lung cancer.

Phase 1

• Conditions: Patients with small cell lung cancer, who are going to receive chemotherapy treatment with a platinum- and topoisomeras inhibitor containing regimen.; MedDRA version: 14.1Level: LLTClassification code 10041067Term: Small cell lung cancerSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2007-006033-14-SE
• Lead Sponsor: niversity Hospital Lund, Thoracic Oncology Unit, Dept of Respiratory Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-02-19
• Study Completion: 2017-05-05
• Last Update Posted: 26 July 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 390

Inclusion Criteria

Histologically or cytologically verified small cell lung cancer, all stages
WHO Performance Status 0-3
Age 18 years or older
Intention and feasibility to treat with chemotherapy consisting of a platinum and a topoisomeras inhibitor
Platelets over 100 x 10 9/L
PK (prothrombine komplex) INR and APTT within normal ranges
Signed informed concent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 290

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
Any other known contraindication for enoxaparine (eg. hypersensitivity against enoxaparine and its derivates
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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective with the study is to evaluate treatment with chemotherapy with a platinum- and a topoisomeras inhibitor containing regimen versus treatment with the same chemotherapy with addition of enoxaparin comparing overall survival.;Secondary Objective: Second objectives are:<br>To evaluate toxicity<br>To evaluate clinically significant haemorrhagia<br>To evaluate progression free survival<br>To evaluate thromboembolic events<br>To perform translational research;Primary end point(s): To demonstrate that addition of enoxaparine to standard chemotherapy treatment containing a platinum- and a topoisomeras inhibitor drug results in a significant increase in overall survival.;Timepoint(s) of evaluation of this end point: During study treatment, at follow up 2 and 12 months after end of treatment, and then untill patients death.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Toxicity<br>Clinically significant hemorrhage<br>Progression free survival<br>Thromboembolic events<br>Relation between different serum- and tumour markers and prognosis with or without enoxaparin;Timepoint(s) of evaluation of this end point: During study treatment, at follow up 2 and 12 months after end of treatment.