Effect of Low Molecular Weight Heparin :Tinzaparin in Lung Tumours (TILT) - Full Text View

Sponsored by:	Assistance Publique - Hôpitaux de Paris
Information provided by:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00475098

Purpose

Experiments suggest that low molecular weight heparin (LMWH) inhibit tumor growth and metastasis. Studies in humans suggest that LMWH is associated with a higher survival in patients with cancer related thrombosis. Two recent studies suggest that LMWH may increase the survival of patients with cancer who do not have an associated thrombosis. The purpose of the study is to assess the effect of LMWH on the overall survival of patients with localized non small cell lung cancer after complete surgical resection.

Condition	Intervention	Phase
Lung Cancer Non Small Cell Lung Cancer	Drug: Tinzaparin sodium 100 UI/Kg/OD for 12 weeks	Phase III

MedlinePlus related topics: Blood Thinners Cancer Lung Cancer

Drug Information available for: Heparin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	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.

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:

Overall 3-year mortality [ Time Frame: overall 3-years ]

Secondary Outcome Measures:

Major bleeding time [ Time Frame: Overall five year survival ]
Symptomatic venous thromboembolic events [ Time Frame: Overall five year survival ]
Cancer related mortality [ Time Frame: Overall five year survival ]
Disease free survival [ Time Frame: Overall five year survival ]

Estimated Enrollment:	800
Study Start Date:	June 2007
Estimated Study Completion Date:	June 2014

Arms	Assigned Interventions
A: Active Comparator	Drug: Tinzaparin sodium 100 UI/Kg/OD for 12 weeks
B: Experimental	Drug: Tinzaparin sodium 100 UI/Kg/OD for 12 weeks

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 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.

Patients follow-up All patients will be followed according to local practice, but at least two outpatients visits with a chest radiograph will be planned each year during the five-year follow-up period.

Duration of the trial. Inclusion period (first patient in to last patient in) : 3 years. Patient total follow-up (from surgery to end of follow-up) : 5 years. Total study period : 8 years.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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 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 5 days 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00475098

Contacts

Contact: Guy MEYER, MD

+33(0) 1 56 09 34 83

guy.meyer@egp.aphp.fr

Locations

France
Hopital Européen Georges Pompidou	Recruiting
PARIS, France, 75015
Contact: Guy MEYER, MD,PhD +33(0) 1 56 09 34 83 guy.meyer@egp.aphp.fr

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

Principal Investigator:

Guy MEYER, MD

Assistance Publique - Hôpitaux de Paris

More Information

Publications of Results:

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. Review. No abstract available.

Study ID Numbers:	P051084, EUDRACT 2006-005546-36
Study First Received:	May 16, 2007
Last Updated:	September 7, 2007
ClinicalTrials.gov Identifier:	NCT00475098
Health Authority:	France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:

Low molecular weight heparin
Lung cancer
Non small cell lung cancer

Adjuvant therapy
Anticoagulants
Heparin

Study placed in the following topic categories:

Thoracic Neoplasms
Non-small cell lung cancer
Heparin, Low-Molecular-Weight
Carcinoma
Calcium heparin
Body Weight
Respiratory Tract Diseases

Lung Neoplasms
Lung Diseases
Tinzaparin
Carcinoma, Non-Small-Cell Lung
Heparin
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Fibrin Modulating Agents
Neoplasms
Anticoagulants
Neoplasms by Site
Neoplasms by Histologic Type

Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Hematologic Agents
Fibrinolytic Agents
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009