Addition of Hypofractionated High Dose Radiation in Oligometastatic Disease
ConditionNon Small Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorVastra Gotaland Region
About this trial
This is a 2:1 randomized multicentre open label phase III study of radiation combined with standard systemic treatment compared with systemic treatment alone in oligometastatic (≤5 metastases) NSCLC. Stratification factors: performance status, gender and systemic strategy. The systemic treatment consists of chemotherapy/chemoimmunotherapy or immunotherapy and is given according to local practice. During the first 3 months of systemic treatment, aiming to start around the 2nd cycle is radiotherapy delivered to all known lesions. Preferably with SBRT /SRT/SRS but conventional radiotherapy may also be used. After the first three cycles of systemic treatment, the patients are assessed, and after four cycles, they are continuing maintenance therapy if indicated. The patients are followed with radiology every three months.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Written informed consent obtained from the subject prior to performing any protocol- related procedures, including screening procedures
Histological or cytological diagnosis of NSCLC
Stage IV disease with ≤5 metastases (not including primary tumour or mediastinal nodes, N1-N3)
Patient deemed fit for first line chemoimmunotherapy, immunotherapy or chemotherapy
Disqualifiers
• Solitary brain lesion or contralateral lung lesion as the only distant metastasis
Participation in another clinical study with an investigational product during the last 4 weeks
Patients with EGFR+, ALK+, ROS1+ disease or any other genetic alteration that would result in a TKI based first line treatment (i.e. first line treatment not being chemoimmuno- or immunotherapy)
Malignant pleural fluid, or ascites (malignant cells or clinical judgement) or excessive fluid hampering radiation according to protocol
Trial design
Design model
Parallel
Treatments tested in this trial
Standard systemic therapy + radiotherapy
Other interventionCombined systemic therapy + radiation
Standard systemic therapy
DrugChemoimmunotherapy or immunotherapy
Treatment groups
240 Participants
are divided into 2 treatment groupsGroup A: A, standard systemic therapyActive comparator 1 intervention
Group B: B, Radiotherapy + systemic therapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Overall survival (OS)
Time to death
Time frame
From date of randomization until the date of death from any cause, whichever came first, assessed up to 60 monthsSecondary outcomes
1
Progression-free survival (PFS)
Time to progressive disease or death
Time frame
From date of randomization until the date of first documented systemic progression or date of death from any cause, whichever came first, assessed up to 60 months2
Local control (LC)
Percentage complete, partial remission or stable disease
Time frame
At 12 months after randomizationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov