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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.

Phase 3
18 Years
Open (Enrolling)
Lung Cancer, Non Small Cell Lung Cancer

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Trial Information

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.

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 five-year follow-up

- 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.

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 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall 3-year mortality

Outcome Time Frame:

overall 3-years

Safety Issue:


Principal Investigator

Guy Meyer, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Assistance Publique - Hôpitaux de Paris


France: Ministry of Health

Study ID:




Start Date:

June 2007

Completion Date:

August 2015

Related Keywords:

  • Lung Cancer
  • Non Small Cell Lung Cancer
  • Low molecular weight heparin
  • Lung cancer
  • Non small cell lung cancer
  • Adjuvant therapy
  • Anticoagulants
  • Heparin
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms