|- candidate number||24302|
|- NTR Number||NTR5836|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||26-apr-2016|
|- Secondary IDs||NL5373610015 PGx Lung cancer|
|- Public Title||Genetic variations as predictors of outcome and toxicity in non-small-cell lung cancer patients undergoing chemoradiation or chemotherapy with platinum agents.|
|- Scientific Title||Genetic variations as predictors of outcome and toxicity in non-small-cell lung cancer patients undergoing chemoradiation or chemotherapy with platinum agents.|
|- ACRONYM||PGx Lung cancer|
|- hypothesis||It 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) studied||Non 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 received||yes|
|- multicenter trial||no|
|- planned startdate ||15-feb-2016|
|- planned closingdate||15-feb-2018|
|- Target number of participants||350|
|- Interventions||Not applicable. |
|- Primary outcome||I. 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 outcome||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.|
|- Timepoints||Patients 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 site||Not applicable. |
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| D. C. de Jong|
|- CONTACT for SCIENTIFIC QUERIES|| D. C. de Jong|
|- Sponsor/Initiator ||St. Antonius Hospital|
(Source(s) of Monetary or Material Support)
|Antonius Onderzoeksfonds, Roche Nederland BV|
|- Brief summary||Case-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)|
|- RECORD||26-apr-2016 - 22-jun-2016|