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DNA repair gene expression levels in NSCLC patients treated with platinum based chemotherapy: an open label randomized phase II study - ND

DNA repair gene expression levels in NSCLC patients treated with platinum based chemotherapy: an open label randomized phase II study - ND

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2008-000936-42-IT
Enrollment
Unknown
Registered
2008-05-21
Start date
2008-05-13
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PATIENTS WITH NSCLC CANCER MedDRA version: 9.1 Level: LLT Classification code 10059515 Term: Non-small cell lung cancer metastatic

Interventions

Trade Name: TAXOTERE*INFUS FL 80MG/2ML+F Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Docetaxel Concentration unit: mg milligram(s) Concentration type: equal Concent

Sponsors

AZIENDA SANITARIA OSPEDALIERA "S. GIOVANNI BATTISTA DI TORINO"
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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 =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

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.

Design outcomes

Primary

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

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026