This study aims to investigate the feasability to use DW-MRI for mediastinal restaging after concomitant chemoradiotherapy and the feasabilitiy to predict whether or not mediastinal downstaging will be achieved during concomitant chemoradiotherapy…
ID
Source
Brief title
Condition
- Respiratory and mediastinal neoplasms malignant and unspecified
- Respiratory tract neoplasms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters/endpoints: Determination of the feasibility to use
DW-MRI in the evaluation of treatment response during and after
chemoradiotherapy treatment for locally advanced NSCLC compared to the
pathological specimen as gold standard.
Secondary outcome
nvt
Background summary
For the group of patients with non-small cell lung cancer with mediastinal
lymph node metastasis the standard treatment consists of concomitant
chemoradiotherapy, additional surgery can be considered for selected patients
(trimodality treatment). Patients seem to benefit from surgery after
chemoradiotherapy when mediastinal downstaging or complete response is
achieved. Mediastinal restaging is difficult and imaging and invasive restaging
methods show a high rate of false negative results. Improvement of radiological
re-staging might improve selection of patients who seem to benefit from surgery
after chemoradiotherapy and reduce the need of invasive restaging techniques.
Study objective
This study aims to investigate the feasability to use DW-MRI for mediastinal
restaging after concomitant chemoradiotherapy and the feasabilitiy to predict
whether or not mediastinal downstaging will be achieved during concomitant
chemoradiotherapy in patients with non-small cell lung cancer with mediastinal
lymph node involvement, without supraclavicular lymph node involvement, stage
III A/ B N2/3.
Study design
Prospective non-randomized cohort study, diagnostic study
Study burden and risks
For study purposes the patients will undergo three extra MRI scans and one
FDG-PET scan. The MRI scans will be performed with an intravenous contrast
agent (gadolinium). For the FDG-PET there is an irradiation load of 3-4 mSv,
this involves mild risk for the patients. These scans will be scheduled in
combination with standard appointments. For the patients included in the study,
there is no individual benefit.
Koekoekslaan 1
Nieuwegein 3435CM
NL
Koekoekslaan 1
Nieuwegein 3435CM
NL
Listed location countries
Age
Inclusion criteria
Patients between 18-76 years old, diagnosed with locally advanced NSCLC with pathologic proven (cytology or histology) mediastinal lymph node metastasis, without supraclaviculair lymph node metastasis, stage III A and B N2/3. Patients are planned for treatment with concomitant chemoradiotherapy.
Exclusion criteria
Supraclaviculair lymph node metastasis or distant metastasis
Other potential curative treatment options
Mixed tumor types with small cell lung cancer
Expected need for pneumonectomy right lung
Participation in other trial with investigational drug or treatment modality
Contraindications MRI
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL54489.100.16 |