OMEGA, Local Ablative Therapy in Oligometastatic NSCLC
Status:
Recruiting
Trial end date:
2022-09-01
Target enrollment:
Participant gender:
Summary
Oligometastatic lung cancer (OM-NSCLC) seems to be associated with a better prognosis than
usual Stage IV non-small cell lung cancer when radical local therapy of all metastatic sites
is administered but the impact of such an approach on overall survival and quality of life
remains to be defined by adequately powered phase III trials.
A consortium of tertiary referral centres involved in Lung Cancer management at the national
level was established to launch a randomized trial of local ablative therapy in OM-NSCLC
patients with potentially resectable or locally controlled primary tumors has been designed.
Inclusion criteria include adequate performance status, primary tumor controlled or
controllable staging with whole-body FDG PET scan and brain MRI, fit to receive at least 3
cycles of platinum-based doublet chemotherapy, or immunotherapy or targeted agents according
to molecular profile.
Exclusion criteria include cerebral oligometastasis alone (will receive local therapy in any
case), metastasis in sites where normal radiotherapy constraints cannot be met, multiple
subsolid nodules in the absence of extrapulmonary metastasis, prior malignant tumor with some
exceptions, relevant co-morbidities that would significantly reduce life expectancy on their
own.
Patients with synchronous or metachronous oligometastatic lung cancer (1-3 metastatic
lesions) will be randomized to local ablative therapy + standard treatment Vs. standard
treatment. Balancing between study arms will be performed according to synchronous vs.
metachronous presentation, Number of oligometastases, Nodal status and Oncogene-addiction or
PDL-1 expression. Primary outcome will be Overall Survival (OS) from randomization. The
sample size is set to 195 patients.
Disease state and life status will be assessed on a 3-monthly basis by physical examination,
whole-body CT scan plus repeat PET-scan if needed and Brain MRI if brain metastasis at
enrolment. Toxicity and adverse events will be assessed according to NCI-Common Terminology
Criteria. And RTOG criteria. Quality of life will be assessed at randomization and after six
months by the SF36/LCSS
A.O.U. Città della Salute e della Scienza - Molinette Hospital Azienda Ospedaliera San Camillo Forlanini Fondazione IRCCS Istituto Nazionale dei Tumori, Milano Fondazione Policlinico Universitario Agostino Gemelli IRCCS Humanitas Research Hospital Milan Policlinico Universitario Agostino Gemelli Regina Elena Cancer Institute San Luigi Gonzaga Hospital