The objective of this study is to identify genetic variations associated with clinical response and toxicity in non-small cell lung cancer patients (NSCLC) undergoing chemoradiation or chemotherapy with platinum agents (carboplatin, cisplatin). The…
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms benign
- Respiratory tract neoplasms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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
Survival time is defined as survival from date of diagnosis in months. Besides,
patient-reported outcomes and quality of life will be compared at 4 points in
time (before treatment, after 3 months of treatment, after 6 months and 1 year
follow-up). Skeletel muscle mass measured on available (PET)CT scans.
Background summary
Lung cancer is the most common malignancy worldwide. Clinical factors including
age, performance status and disease stage influence the likelihood of benefit
from radiation and/or chemotherapy. However, the hypothesis is that the genetic
profile of individual patients is an independent predictor of response and
toxicity. These findings might provide opportunities to personalize therapeutic
strategies.
Study objective
The objective of this study is to identify genetic variations associated with
clinical response and toxicity in non-small cell lung cancer patients (NSCLC)
undergoing chemoradiation or chemotherapy with platinum agents (carboplatin,
cisplatin). The aim of this study is to assess whether TGF*1 polymorphisms are
associated with severe esophagitis in NSCLC patients receiving chemoradiation
as well as to assess the association between ERCC1, SLC22A2 and nephro- and
neurotoxicity in patients treated with platinum agents. In addition, the
association between genetic variations and toxicity for CYP2C19, tPA, ACE,
EGFR, ENG, TRAF3, ITGB2, PTGS2, IL1A, IL8, TNF, TNFRSF1B, MIF, NOS3, PRKCE,
TNFSF7 (chemoradiation) and NAT2, EPHX1, eIF3*, SLC47A1, GSTT1 (chemotherapy
with platinum agents) will be investigated. Secondary objective(s) include
evaluating survival rates, the correlation of delay, switching and
discontinuation of treatment as well as the patient-reported outcome measures
(quality of life) of radiation and/or chemotherapy in NSCLC patients with and
without genetic variants. In addition, to determine the association between
skeletel muscle mass and occurence of chemotherapy related toxicities.
Study design
Retrospectively and prospectively nested case-control study. Medical charts
will be reviewed and patients will be asked to donate blood samples during
regular hospital visits as part of regular care. Besides, patients will be
asked to fill out the EQ-5D, EORTC QLQ-C30, EORTC QLQ-LC13 and EORTC QLQ-CIPN20
questionnaires at 4 points in time during 1 year follow-up.
Study burden and risks
The burden for patients participating in the study is that blood samples will
be collected during regular care. This does not imply an additional
venipuncture. Besides, patients will be asked to complete questionnaires to a
maximum of 4 points in time; before chemoradiation/chemotherapy, after 3 months
of treatment, after 6 months and 1 year follow-up.
Koekoekslaan 1
Nieuwegein 3430 EM
NL
Koekoekslaan 1
Nieuwegein 3430 EM
NL
Listed location countries
Age
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
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL53736.100.15 |
| OMON | NL-OMON27534 |