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 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.
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 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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall 3-year mortality
Guy Meyer, MD
Assistance Publique - Hôpitaux de Paris
France: Ministry of Health