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

NCT00475098 | Completed Phase 3 DMC

• 1 other identifier: P051084
• Study Type: interventional
• Target: 553
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Cancer; Non Small Cell Lung Cancer

Keywords

Low molecular weight heparin; Lung cancer; Non small cell lung cancer; Adjuvant therapy; Anticoagulants; Heparin

Outcome Measures

Primary Outcomes (1)

• Overall 3-year mortality

  The first included patients will be followed 9 years with no impact on the total duration of the study.

  overall 3-years

Secondary Outcomes (4)

• Major bleeding time

  Overall five year survival

• Symptomatic venous thromboembolic events

  Overall five year survival

• Cancer related mortality

  Overall five year survival

• Disease free survival

  Overall five year survival

Study Arms (2)

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

Interventions

Tinzaparin sodium 100 UI/Kg/OD for 12 weeks DRUG

treatment in lung tumours

Also known as: treatment in lung tumours

A; B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hopital Européen Georges Pompidou

Paris, 75015, France

Location

Related Publications (3)

• 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.

  PMID: 15302749 RESULT

• 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.

  PMID: 33337539 DERIVED

• 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.

  PMID: 30262574 DERIVED

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Tinzaparin; Therapeutics

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Guy Meyer, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

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: May 16, 2007
• First Posted: May 17, 2007
• Study Start: June 1, 2007
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: September 2, 2016

Record last verified: 2016-08

Locations

FR (1)