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Effect of Low Molecular Weight Heparin: Tinzaparin in Lung Tumours (TILT)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00475098
First received: May 16, 2007
Last updated: October 7, 2014
Last verified: May 2007
  Purpose

Experiments suggest that low molecular weight heparin (LMWH) inhibits 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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Overall 3-year mortality [ Time Frame: overall 3-years ] [ Designated as safety issue: No ]
    The first included patients will be followed 9 years with no impact on the total duration of the study.


Secondary Outcome Measures:
  • Major bleeding time [ Time Frame: Overall five year survival ] [ Designated as safety issue: No ]
    Disease free survival of the first enrolled patients will be assessed 9 years after inclusion

  • Symptomatic venous thromboembolic events [ Time Frame: Overall five year survival ] [ Designated as safety issue: No ]
    Symptomatic venous thromboembolic events of the first enrolled patients will be assessed 9 years after inclusion

  • Cancer related mortality [ Time Frame: Overall five year survival ] [ Designated as safety issue: No ]
    Cancer related mortality of the first enrolled patients will be assessed 9 years after inclusion

  • Disease free survival [ Time Frame: Overall five year survival ] [ Designated as safety issue: No ]
    Disease free survival of the first enrolled patients will be assessed 9 years after inclusion


Enrollment: 553
Study Start Date: June 2007
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A Drug: Tinzaparin sodium 100 UI/Kg/OD for 12 weeks
treatment in lung tumours
Other Name: treatment in lung tumours
Experimental: B Drug: Tinzaparin sodium 100 UI/Kg/OD for 12 weeks
treatment in lung tumours
Other Name: treatment in lung tumours

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.

  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 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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
France
Hopital Européen Georges Pompidou
Paris, France, 75015
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Guy Meyer, MD Assistance Publique - Hôpitaux de Paris
  More Information

Publications:
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00475098     History of Changes
Other Study ID Numbers: P051084
Study First Received: May 16, 2007
Last Updated: October 7, 2014
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

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Dalteparin
Heparin
Heparin, Low-Molecular-Weight
Tinzaparin
Anticoagulants
Cardiovascular Agents
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014