Adjuvant BEmiparin in Small Cell Lung Carcinoma (ABEL STUDY)

Summary

Main objective:

To evaluate whether the subcutaneous administration (sc) of Bemiparin (3,500 UI/day) 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 (3,500 UI/day) 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).

Conditions

• Carcinoma, Small Cell

Interventions

DRUG

Bemiparin

subcutaneous administration (sc) of Bemiparin (3,500 UI/day) for 26 weeks, starting on the first day of chemotherapy (CT)

Sponsors & Collaborators

• Clinica Universidad de Navarra, Universidad de Navarra

  lead OTHER

Principal Investigators

• Alfonso Gúrpide, MD · Clínica Universitaria de Navarra

• Enrique Gonzalez, MD · Hospital General Universitario Morales Meseguer

• Guillermo López, MD · Hopspital de Cruces, Baracaldo (Vizcaya)

• César Rodríguez, MD · Hospital Clínico de Salamanca

• Juan C. Torrego, MD · Hospital del Rio Hortega

• José Gómez, MD · HOSPITAL LA FE VALENCIA

• Albert Font, MD · Germans Trias i Pujol Hospital

• Isidoro C. Barneto, MD · Hospital Reina Sofia (Córdoba)

• Antonio Lorenzo, MD · Hospital de Puerto Real (Cádiz)

• Dolores Isla, MD · Hospital Clínico Lozano Blesa (Zaragoza)

• Eduardo Rocha, MD · Clínica Universitaria de Navarra

• Bartolomeu Massuti, MD · Hospital General Universitario de Alicante

• Antonio Galán Brotons, MD · Hospital de Sagunto

• Ana Blasco Cordellat, MD · Hospital General Universitario de Valencia

• Juan J. Bretón, MD · Hospital Universitario Carlos Haya

• Isabel Bover Barceló, MD · Hospital Son Llàtzer

• Nuria Viñolas, MD · Hospital Clinic i provincial de Barcelona

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2005-06-30

Primary Completion

2010-02-28

Completion

2010-09-30

Countries

• Spain

Study Locations