No registrations found.
ID
Source
Brief title
Health condition
NSCLC
Niet-kleincellig longcarcinoom
Toxicity
Toxiciteit
Platinum agents
Platinumhoudende chemotherapie
Sponsors and support
Roche Nederland B.V.
Intervention
Outcome measures
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.
Background 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.
Study objective
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.
Study design
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.
Intervention
Not applicable.
D. C. de Jong
Nieuwegein
The Netherlands
088-3207278
dc.de.jong@antoniusziekenhuis.nl
D. C. de Jong
Nieuwegein
The Netherlands
088-3207278
dc.de.jong@antoniusziekenhuis.nl
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).
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5692 |
| NTR-old | NTR5836 |
| CCMO | NL53736.100.15 |
| OMON | NL-OMON47255 |