Genetic variations as predictors of outcome and toxicity in non-small-cell lung cancer patients undergoing chemoradiation or chemotherapy with platinum agents.
Recruiting
- Conditions
- SCLCNiet-kleincellig longcarcinoomToxicityToxiciteitPlatinum agentsPlatinumhoudende chemotherapie
- Registration Number
- NL-OMON27534
- Lead Sponsor
- St Antonius Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 350
Inclusion Criteria
Diagnosed with NSCLC (stage II-IV).
- Age >18 year.
Exclusion Criteria
- Unable to give informed consent.
- Patients with cognitive impairment or those who are not able to read or write Dutch (because of difficulties in completing questionnaires).
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method I. To determine the association between ERCC1 and SLC22A2 genotypes and nephro- and neurotoxicity.<br /><br>II. To determine the association between TGFb1 genotypes and severe esophagitis after chemoradiation in NSCLC patients.<br /><br>III. Investigate the association between genetic variations and toxicity for CYP2C19, tPA, ACE, EGFR, ENG, TRAF3, ITGB2, PTGS2, IL1A, IL8, TNF, TNFRSF1B, MIF, NOS3, PRKCE, TNFSF7 NAT2, EPHX1, eIF3á, SLC47A1, GSTT1.<br><br /><br /><br>Main study parameters/endpoints: esophagitis (grade 1-4), nephrotoxicity (grade 1-4), neurotoxicity (grade 1-4) and genetic markers. All toxicities will be graded according to ‘National Cancer Institute Common Terminology Criteria for Adverse Events’ (NCI CTCAE), v4.0.
- Secondary Outcome Measures
Name Time Method Secondary objective(s) include evaluating survival rates (OS), the correlation of delay, switching and discontinuation of treatment as well as the patient-reported outcome measures (quality of life) in patients with and without genetic variants.