Status:
UNKNOWN
OMEGA, Local Ablative Therapy in Oligometastatic NSCLC
Lead Sponsor:
Azienda Ospedaliera Universitaria Integrata Verona
Collaborating Sponsors:
A.O.U. Città della Salute e della Scienza - Molinette Hospital
San Luigi Gonzaga Hospital
Conditions:
Carcinoma, Non-Small-Cell Lung
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
Brief 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 ...
Detailed Description
Lung cancer is a systemic disease with local manifestations that are ultimately responsible for a reduced life expectancy in a relatively large subgroup of metastatic lung cancer patients. In such a ...
Eligibility Criteria
Inclusion
- Inclusion criteria
- ECOG performance status 0-1 at the time of randomization
- Pathologically confirmed NSCLC.
- Staging with whole-body FDG PET scan and brain MRI or CT with IV contrast.
- Between 1 and 3 metastatic lesions, assessable according to RECIST v1.1 and suitable for LAT prior to trial registration.
- Primary tumor controlled (metachronous oligometastasis) or resectable/suitable for ablative radiotherapy.
- Patient is deemed fit to receive at least 3 cycles of platinum-based doublet chemotherapy, cisplatin or carboplatin, according to local guidelines.
- If pulmonary involvement, it must be bilateral with at least 3 lung lesions, or extrapulmonary metastasis must be present
- If brain involvement, up to 2 brain metastases, the largest brain lesion \< 3cm in maximum diameter at the time of randomization.
- Exclusion criteria
- Any tumor site besides brain metastasis requiring immediate LAT for palliation.
- Patient has received previous LAT for extra-cerebral metastasis
- Patient has received previous systemic treatment for his/her NSCLC malignancy and is experiencing disease progression at the time of randomization (except adjuvant chemotherapy and/or radiotherapy more than 6 months earlier)
- Patient has had palliative radiotherapy to any tumor site prior to registration and/or requires palliative radiotherapy prior to randomization.
- High clinical suspicion of direct invasion of the wall of any major blood vessel or medulla by the primary tumor or metastasis
- Brain metastasis within the brainstem, or leptomeningeal disease.
- Metastasis in sites where normal radiotherapy constraints cannot be met or in a previously irradiated area
- Malignant pleural or pericardial effusion.
- Lung tumors with a single additional nodule in the same lobe, same lung or in the contralateral lung, i.e. T3, T4 or M1a lung cancer, in the absence of extrapulmonary involvement.
- Lung involvement in the form of multiple nonsolid or subsolid nodules, in the absence of extrapulmonary metastasis \[18\]
- History of prior malignant tumour likely to interfere with the protocol treatment or comparisons (excluding H\&N primary, radically treated, no recurrence over the last 5 years, non-melanoma skin cancer, in situ cervical cancer, DCIS or LCIS of the breast
- Any relevant co-morbidities that would significantly reduce life expectancy on their own, such as heart failure, advanced COPD, uncontrolled diabetes, end-stage renal disease etc.
- Women who are pregnant or breast feeding.
Exclusion
Key Trial Info
Start Date :
October 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2022
Estimated Enrollment :
195 Patients enrolled
Trial Details
Trial ID
NCT03827577
Start Date
October 1 2019
End Date
September 1 2022
Last Update
January 18 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Azienda Ospedaliera Universitaria Integrata
Verona, Italy, 37126