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Genetic variations as predictors of outcome and toxicity in non-small-cell lung cancer patients undergoing chemoradiation or chemotherapy with platinum agents.


- candidate number24302
- NTR NumberNTR5836
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR26-apr-2016
- Secondary IDsNL5373610015 PGx Lung cancer
- Public TitleGenetic variations as predictors of outcome and toxicity in non-small-cell lung cancer patients undergoing chemoradiation or chemotherapy with platinum agents.
- Scientific TitleGenetic variations as predictors of outcome and toxicity in non-small-cell lung cancer patients undergoing chemoradiation or chemotherapy with platinum agents.
- ACRONYMPGx Lung cancer
- hypothesisIt is hypothesized that the genetic profile of individual patients is a predictor of response and toxicity. Subsequently, this study might provide opportunities to personalize therapeutic strategies in NSCLC treatment and optimize patient outcome, enabling (radiation) oncologists to adjust planned doses to minimize toxicity while optimizing effectiveness of treatment.
- Healt Condition(s) or Problem(s) studiedNon small cell lung cancer (NSCLC), Toxicity, Platinum sensitive
- Inclusion criteria- Diagnosed with NSCLC (stage II-IV).
- Age >18 year.
- Received or starting with chemoradiation or chemotherapy with platinating agents (carboplatin, cisplatin).
- 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).
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 15-feb-2016
- planned closingdate15-feb-2018
- Target number of participants350
- InterventionsNot applicable.
- Primary outcomeI. To determine the association between ERCC1 and SLC22A2 genotypes and nephro- and neurotoxicity.
II. To determine the association between TGFb1 genotypes and severe esophagitis after chemoradiation in NSCLC patients.
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.

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 outcomeSecondary 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.
- TimepointsPatients will be asked to donate blood and complete questionnaires to a maximum of 4 points in time; at the moment of inclusion, after 3, 6 and 12 months.
- Trial web siteNot applicable.
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES D. C. de Jong
- CONTACT for SCIENTIFIC QUERIES D. C. de Jong
- Sponsor/Initiator St. Antonius Hospital
- Funding
(Source(s) of Monetary or Material Support)
Antonius Onderzoeksfonds, Roche Nederland BV
- Publications
- Brief summaryCase-control study to determine the association between ERCC1, SLC22A2 and TGFb1 genotypes and esophagitis, nephro- and neurotoxicity in patients with non-small-cell lung cancer undergoing chemoradiation or chemotherapy with platinum agents.
- Main changes (audit trail)
- RECORD26-apr-2016 - 22-jun-2016


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