DNA repair gene expression levels in NSCLC patients treatedwith platinum based chemotherapy: an open labelrandomized phase II study - ND

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Diagnosis of NSCLC stage III-IV treated with first line
chemotherapy with cisplatin + docetaxel or cisplatin +
gemcitabine
Male or female, 18 years of age or older
Histologically proven non-small-cell-lung carcinoma
Chemotherapy naive
ECOG performance status =2
ANC =150/mcL
Platelets 100000/mcL
Adequate renal function (serum creatinine <1.5 x upper
limit of normal, ULN)
Before any study specific procedure the subject must give
written informed consent for participation in the study
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) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

active or uncontrolled Infection.
present or past history of hypersensivity.
acute cardiovascular Pathology ongoing or recent (last two months).
Diabetes mellitus not controlled.
Second cancer within the previous 5 years (except for carcinoma in situ of portio, skin carcinomas, superficial bladder cancer for which it is considered radical treatment run).
Unable to close follow-up when you should verify significant toxicity.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: Identification of response differences between standard<br>chemotherapy regimens associated to cisplatin (docetaxel<br>or gemcitabine) relative to DNA repair gene expression<br>levels.;Main Objective: Evaluation of a correlation between response to standard<br>chemotherapy and ERCC1, ERCC4 XRCC1, XRCC3,<br>RRM1 e BRCA1 expression in PBMC.<br>Identification of a cut-off in expression mRNA levels to<br>define a range of high and low expression associated to<br>response to chemotherapy;Primary end point(s): Evaluation of a correlation between response to standard<br>chemotherapy and ERCC1, ERCC4 XRCC1, XRCC3,<br>RRM1 e BRCA1 expression in PBMC.<br>Identification of a cut-off in expression mRNA levels to<br>define a range of high and low expression associated to<br>response to chemotherapy

Secondary Outcome Measures