- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00475098
Effect of Low Molecular Weight Heparin: Tinzaparin in Lung Tumours (TILT) (TILT)
Effect of Low Molecular Weight Heparin on Survival of Stage I,II or IIIA Non Small Cell Lung Cancer. A Multicenter, Open, Randomized Controlled Trial.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Phase III, prospective, multicentric, randomized, controlled, open trial in parallel groups with a blind adjudication of all end-point criteria.
Reference therapy :
Patients randomized to the control group will receive postoperative treatment according to local practice in the participating centers. However, the participating centers will have to comply with the following guidelines.
Adjuvant chemotherapy:
Adjuvant chemotherapy will be offered in all patients with stage II and stage IIIA cancers. Adjuvant chemotherapy will be platin based and include two drugs for a maximum of 4 cycles. Each center will have to select one regimen before the beginning of the study for all patients included in the study.
Preoperative chemotherapy:
Patients who had chemotherapy before surgery can be included in the study provided that they had a complete surgical resection. In this case the tumor stage for stratification will be the pathologic stage assessed after surgery.
Stage I cancers:
Patients with stage I cancer who will not be selected for postoperative chemotherapy can be included in the study. Contraindication to chemotherapy Patients with a contraindication to postoperative chemotherapy and those who refuse chemotherapy can be included in the study provided they fulfill all inclusion and exclusion criteria.
Experimental treatment:
Experimental treatment is tinzaparin administered subcutaneously once a day at the dose of 100 IU/Kg during a twelve week period beginning after a maximum period of 8 weeks after surgery. Patients randomized in the experimental group will receive adjuvant postoperative treatment according to local practice with the same guidelines as in the control group.
- Patient follow-up:
All patients will be followed according to local practice, but at least two outpatient visits with a chest radiograph will be planned each year during the three year follow-up period after last inclusion.
- Duration of the trial:
Inclusion period (first patient in to last patient in) : 6 years. Patient total follow-up (from surgery to end of follow-up) : 3 years after last inclusion (first enrolled patients were followed 9 years). Total study period : 9 years.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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-
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Paris, France, 75015
- Hopital Europeen Georges Pompidou
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Patients with completely resected non-small cell lung cancer of stage I, II, or IIIA T3N1 confirmed by histology can be included in the study Patients who had preoperative chemotherapy, those who are selected for adjuvant chemotherapy and those who are not candidates for adjuvant chemotherapy (because they have a contraindication to chemotherapy or they have a stage I cancer) are eligible for the study Written informed consent age > 18 years
Exclusion Criteria:
Previous heparin induced thrombocytopenia Allergy to tinzaparin Allergy to sulfites Renal failure with a creatinin clearance < 30 ml/min according to COCKROFT formula Prothrombin time < 50% Platelet count < 100 G/L Increased bleeding risk: ongoing hemorrhage, major bleeding within 10 days, previous intracerebral bleeding, uncontrolled hypertension (SAP > 180 mmHg or DAP > 120 mmHg) Indication for curative anticoagulant treatment on inclusion More than 6 weeks between surgery and inclusion Known pregnancy or no efficient contraception for women of childbearing age Breast feeding Previous malignant disease diagnosed within 2 years except in situ carcinoma of the uterine cervix or spinal-cellular or baso-cellular cutaneous carcinoma Inclusion in another therapeutic trial at the time of inclusion Treatment with an experimental drug within 30 days before inclusion in the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: A
|
treatment in lung tumours
Other Names:
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Experimental: B
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treatment in lung tumours
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall 3-year mortality
Time Frame: overall 3-years
|
The first included patients will be followed 9 years with no impact on the total duration of the study.
|
overall 3-years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Major bleeding time
Time Frame: Overall five year survival
|
Disease free survival of the first enrolled patients will be assessed 9 years after inclusion
|
Overall five year survival
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Symptomatic venous thromboembolic events
Time Frame: Overall five year survival
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Symptomatic venous thromboembolic events of the first enrolled patients will be assessed 9 years after inclusion
|
Overall five year survival
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Cancer related mortality
Time Frame: Overall five year survival
|
Cancer related mortality of the first enrolled patients will be assessed 9 years after inclusion
|
Overall five year survival
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Disease free survival
Time Frame: Overall five year survival
|
Disease free survival of the first enrolled patients will be assessed 9 years after inclusion
|
Overall five year survival
|
Collaborators and Investigators
Investigators
- Principal Investigator: Guy Meyer, MD, Assistance Publique - Hôpitaux de Paris
Publications and helpful links
General Publications
- Rutjes AW, Porreca E, Candeloro M, Valeriani E, Di Nisio M. Primary prophylaxis for venous thromboembolism in ambulatory cancer patients receiving chemotherapy. Cochrane Database Syst Rev. 2020 Dec 18;12(12):CD008500. doi: 10.1002/14651858.CD008500.pub5.
- Alifano M, Benedetti G, Trisolini R. Can low-molecular-weight heparin improve the outcome of patients with operable non-small cell lung cancer? An urgent call for research. Chest. 2004 Aug;126(2):601-7. doi: 10.1378/chest.126.2.601. No abstract available.
- Meyer G, Besse B, Doubre H, Charles-Nelson A, Aquilanti S, Izadifar A, Azarian R, Monnet I, Lamour C, Descourt R, Oliviero G, Taillade L, Chouaid C, Giraud F, Falcoz PE, Revel MP, Westeel V, Dixmier A, Tredaniel J, Dehette S, Decroisette C, Prevost A, Pichon E, Fabre E, Soria JC, Friard S, Stern JB, Jabot L, Dennewald G, Pavy G, Petitpretz P, Tourani JM, Alifano M, Chatellier G, Girard P. Anti-tumour effect of low molecular weight heparin in localised lung cancer: a phase III clinical trial. Eur Respir J. 2018 Oct 4;52(4):1801220. doi: 10.1183/13993003.01220-2018. Print 2018 Oct.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Molecular Mechanisms of Pharmacological Action
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Anticoagulants
- Heparin, Low-Molecular-Weight
- Tinzaparin
- Dalteparin
Other Study ID Numbers
- P051084
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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