Ignite Creation Date:
2024-05-05 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00324558
Status:
TERMINATED
Last Update Posted:
2012-06-08
First Post:
2006-05-09
Brief Title:
Adjuvant BEmiparin in Small Cell Lung Carcinoma ABEL STUDY
Sponsor:
Clinica Universidad de Navarra Universidad de Navarra
Organization:
Clinica Universidad de Navarra Universidad de Navarra
Study Overview
Official Title:
Multicenter Randomized Open and Sequential Study to Evaluate the Efficacy and Safety of Bemiparin Administration on the Response to Treatment in Patients Diagnosed With Limited Small Cell Lung Cancer
Status:
TERMINATED
Status Verified Date:
2012-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor stopped due to difficulties to recruit 130 patients required by protocol
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Main objective
To evaluate whether the subcutaneous administration sc of Bemiparin 3500 UIday for 26 weeks starting on the first day of chemotherapy CT delays tumoral spread and increases progression-free survival
Secondary objectives
To evaluate whether the subcutaneous administration sc of Bemiparin 3500 UIday for 26 weeks starting with the onset of chemotherapy increases global survival improving the response rates to treatment with CT RT radiotherapy and reduces the incidence of venous thromboembolism VTE
To evaluate whether the subcutaneous administration sc of Bemiparin 3500 UIday for 26 weeks starting on the first day of chemotherapy CT delays tumoral spread and increases progression-free survival
Secondary objectives
To evaluate whether the subcutaneous administration sc of Bemiparin 3500 UIday for 26 weeks starting with the onset of chemotherapy increases global survival improving the response rates to treatment with CT RT radiotherapy and reduces the incidence of venous thromboembolism VTE
Detailed Description:
There is clinical evidence indicative of the beneficial effects of heparin in the evolution of patients with cancer Apart from the studies that in an indirect way demonstrated an increase in the survival of oncological patients who because of presenting a venous thromboembolism episode were treated with low molecular weight heparin LMWH in comparison with those treated with non-fractionated heparin direct actions were also demonstrated from the use of heparin in the survival and tumour progression The administration of LMWH together with Chemotherapy has been proved to increase the survival of patients diagnosed of cancer of the pancreas in relation to those only treated with chemotherapy An increase in the global survival of advanced solid tumours with no thromboembolic diseasehas also been showed
All this suggests that an improvement in the survival of patients is observed when heparin is added to the usual anti-tumour treatment especially to those without spread disease and this effect seems to be independent of the protection against the thromboembolic complications
All this suggests that an improvement in the survival of patients is observed when heparin is added to the usual anti-tumour treatment especially to those without spread disease and this effect seems to be independent of the protection against the thromboembolic complications
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2004-004722-27 Nº EudraCT | None | None | None |