A single-arm phase II study of dose-dense gemcitabine and carboplatin as neoadyuvant chemotherapy, with pegfilgrastim support for subjects with operable stage IIIA NSCLC

• Conditions: on-small cell lung cancer

• Registration Number: EUCTR2005-001005-26-ES
• Lead Sponsor: Spanish Lung Cancer Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05-17
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- Subjects with Stage IIIA NSCLC (any subtype), confirmed by histological or cytological diagnosis
- Clinically measurable lesions amenable to curative surgical resection
- No prior tumoral therapy
- Men or women between 18 and 65 years old
- ECOG status of 0-1
- Adequate baseline hematology and adequate liver and renal function

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Subjects with Stage I-II and Stage IIIB-IV disease
- Concurrent administration of any other tumoral therapy, including radiotherapy, cytotoxic chemotherapy, inmunotherapy, molecualr target therapy
- Treatment with a investigator drug in the last 30 days before the inclusion period
- Non-controlled diabetes mellitus
- Previous significant neurological or mental disorder, such a epilepsy or madness
- Another primary maligny neoplasie detected during the inclusion period

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified