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,…
ID
Bron
Verkorte titel
Aandoening
NSCLC
Niet-kleincellig longcarcinoom
Toxicity
Toxiciteit
Platinum agents
Platinumhoudende chemotherapie
Ondersteuning
Roche Nederland B.V.
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
I. To determine the association between ERCC1 and SLC22A2 genotypes and nephro- and neurotoxicity.<br>
II. To determine the association between TGFb1 genotypes and severe esophagitis after chemoradiation in NSCLC patients.<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>
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.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
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.
Onderzoeksproduct en/of interventie
Not applicable.
Publiek
D. C. de Jong
Nieuwegein
The Netherlands
088-3207278
dc.de.jong@antoniusziekenhuis.nl
Wetenschappelijk
D. C. de Jong
Nieuwegein
The Netherlands
088-3207278
dc.de.jong@antoniusziekenhuis.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- Diagnosed with NSCLC (stage II-IV).
- Age >18 year.
- Received or starting with chemoradiation or chemotherapy with platinating agents (carboplatin, cisplatin).
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- 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).
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL5692 |
| NTR-old | NTR5836 |
| CCMO | NL53736.100.15 |
| OMON | NL-OMON47255 |