Study Stopped
The external funding (pharmaceutical company) was stopped and could not be substituded by internal funding.
Taxotere-Enoxaparin-(ENOXA)-Study
1 other identifier
interventional
14
1 country
1
Brief Summary
Taxotere-Enoxaparin-(ENOXA)-Study: 1st-Line Docetaxel-Platin Chemotherapy as single therapy or in combination with Enoxaparin in patients aged older than 18 years with locally advanced or metastatic non-small cell lung cancer (stadium IIIb/IV), a phase III study. Study hypothesis: Increase of progressive free survival from 5 to 7.5 months.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 nonsmall-cell-lung-cancer
Started Nov 2009
Shorter than P25 for phase_3 nonsmall-cell-lung-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
January 28, 2010
CompletedFirst Posted
Study publicly available on registry
January 29, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2011
CompletedAugust 22, 2018
August 1, 2018
1.3 years
January 28, 2010
August 21, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progressive free survival
monthly
Secondary Outcomes (6)
Overall survival
monthly
RECIST
monthly
Quality of life
every three months
thromboembolic complications
monthly
safety of long term application of Enoxaparin
monthly
- +1 more secondary outcomes
Study Arms (2)
Arm B: Enoxaparin
EXPERIMENTALArm A: No Enoxaparin
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Signed informed consent
- Men and women aged 18 and older
- Locally Advanced or Metastatic Non-small Cell Lung Cancer stage IIIB/IV without any previous therapy
- Life expectancy at least 12 weeks
- EOCG performance \< 1
- Appropriate renal and hepatic function
- Appropriate Hematology
- No bleeding events within 4 weeks prior to randomization
- No indication for prophylactic or therapeutic anticoagulation therapy
- Appropriate methods of contraception (both: men and women) for women of childbearing potential negative urine pregnancy test within 7 day prior to randomization
- Capability for s.c. injection of Enoxaparin every 24 hrs
You may not qualify if:
- History of cancer other than NSCLC
- Known contraindication for Enoxaparin e.g. HIT,
- Known contraindication for Docetaxel, Cisplatin, Carboplatin or co-medication
- Participation in any other clinical trials within 30 days prior to randomization
- Any known medical condition that does not allow therapy according to study protocol
- Seizure disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hannover Medical School, Department of Pneumology
Hanover, Lower Saxonia, 30625, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Nicolas Dickgreber, MD
Hannover Medical School
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 28, 2010
First Posted
January 29, 2010
Study Start
November 1, 2009
Primary Completion
February 1, 2011
Study Completion
February 1, 2011
Last Updated
August 22, 2018
Record last verified: 2018-08