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Clinical Trials/EUCTR2007-006033-14-DK
EUCTR2007-006033-14-DKActive, not recruitingPhase 1

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

niversity Hospital Lund, Thoracic Oncology Unit, Dept of Respiratory Medicine0 sites390 target enrollmentStarted: March 17, 2014Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Sponsor
Enrollment
390
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

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

Investigators

Sponsor
niversity Hospital Lund, Thoracic Oncology Unit, Dept of Respiratory Medicine

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