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OMEGA, Local Ablative Therapy in Oligometastatic NSCLC (OMEGA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03827577
Recruitment Status : Recruiting
First Posted : February 1, 2019
Last Update Posted : January 18, 2020
Sponsor:
Collaborators:
A.O.U. Città della Salute e della Scienza - Molinette Hospital
San Luigi Gonzaga Hospital
Regina Elena Cancer Institute
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Azienda Ospedaliera San Camillo Forlanini
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Humanitas Research Hospital Milan
Information provided by (Responsible Party):
Azienda Ospedaliera Universitaria Integrata Verona

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 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


Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Procedure: Surgical removal of primary and/or of all oligometastases Radiation: Non-surgical LAT Drug: Standard medical therapy Phase 3

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 subgroup, local ablative therapy of the primary tumor and of all metastatic lesions with a combination of surgery and/or radiotherapy should lead to a clinically significant improvement of their overall survival with acceptable morbidity and preserved Quality of Life compared with medical treatment alone

OMEGA is a randomized trial of local ablative therapy in NSCLC patients with potentially resectable or locally controlled primary tumors and oligometastatic disease

The decision to randomise OM-NSCLC patients either before any systemic therapy or after 3 months of treatment without progression is left to the recruiting centre(s).

Local ablative therapy will be administered in any case to patients harboring cerebral oligometastasis

Statistical methods

Dynamic balancing as per the method of Pocock and Simon [16] according to:

  • Synchronous vs. metachronous presentation
  • Number of oligometastases (1 vs. 2-3) including extrathoracic N3 disease
  • Nodal status (N0 vs. N+)
  • Oncogene-addiction (EGFR/ALK/ROS-1 driven or PDL1 >50% vs <50% vs. wild type)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 195 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: OMEGA, A Randomized Trial of Local Ablative Therapy Vs. Conventional Treatment in Oligometastatic NSCLC
Actual Study Start Date : October 1, 2019
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : September 2022

Arm Intervention/treatment
Experimental: LAT arm

Lung resection (if primary in place) + local ablative therapy of all metastatic sites + standard medical treatment.

patients may be enrolled either before any systemic therapy or after 3 months of treatment without progression according to local coordinator decision

Procedure: Surgical removal of primary and/or of all oligometastases
Standard lobectomy or segmentectomy if tumor resectable without pneumonectomy (prefer lobectomy if cardiorespiratory function is not or only moderately compromised, prefer segmentectomy if primary tumor less than 2 cm or cardiorespiratory function is more than moderately compromised but still permissive) Mediastinal lymph node dissection (at least 8 lymphnodes from at least 3 stations including station 7).

Radiation: Non-surgical LAT
Non-surgical LAT may be carried out either by SABR or SBRT or RFA according to site of metastasis, local expertise and availability of resources.

Drug: Standard medical therapy
platinum-based doublet according to local protocols or targeted agents according to EGFR/ALK/ROS-1 mutational status or immunotherapy agents according to PDL1 expression.

Active Comparator: Control Arm

Standard medical treatment

Local ablative therapy on the brain will be administered in any case to patients harboring cerebral oligometastases

Drug: Standard medical therapy
platinum-based doublet according to local protocols or targeted agents according to EGFR/ALK/ROS-1 mutational status or immunotherapy agents according to PDL1 expression.




Primary Outcome Measures :
  1. Overall survival [ Time Frame: from date of randomization until date of death from any cause up to 60 months ]
    time interval from randomization until death from any cause



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03827577


Contacts
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Contact: Maurizio V Infante, MD +390458123335 maurizio.infante@aovr.veneto.it
Contact: Sara Pilotto, MD sara.pilotto@univr.it

Locations
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Italy
Azienda Ospedaliera Universitaria Integrata Recruiting
Verona, Italy, 37126
Contact: Maurizio V Infante, MD       maurizio.infante@aovr.veneto.it   
Sub-Investigator: Sara Pilotto, MD         
Principal Investigator: Maurizio V Infante, MD         
Sub-Investigator: Antonio Santo, MD         
Sponsors and Collaborators
Azienda Ospedaliera Universitaria Integrata Verona
A.O.U. Città della Salute e della Scienza - Molinette Hospital
San Luigi Gonzaga Hospital
Regina Elena Cancer Institute
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Azienda Ospedaliera San Camillo Forlanini
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Humanitas Research Hospital Milan
Investigators
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Principal Investigator: Maurizio V Infante Azienda Ospedaliera Universitaria Integrata Verona
Principal Investigator: Michele Milella, PhD Azienda Ospedaliera Universitaria Integrata Verona
Principal Investigator: Emilio Bria, PhD Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Publications:
https://evs.nci.nih.gov/ftp1/CTCAE/About.html

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Responsible Party: Azienda Ospedaliera Universitaria Integrata Verona
ClinicalTrials.gov Identifier: NCT03827577    
Other Study ID Numbers: 1533CESC
First Posted: February 1, 2019    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases