Ignite Creation Date:
2024-05-05 @ 5:30 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00475098
Status:
COMPLETED
Last Update Posted:
2016-09-02
First Post:
2007-05-16
Brief Title:
Effect of Low Molecular Weight Heparin Tinzaparin in Lung Tumours TILT
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Effect of Low Molecular Weight Heparin on Survival of Stage III or IIIA Non Small Cell Lung Cancer A Multicenter Open Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2016-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TILT
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
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 IUKg 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
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 IUKg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None