Unfortunately, most patients are already at a very advanced stage when they are diagnosed with lung cancer, i.e. the cancer has already spread outside the lungs forming metastases. The current standard of care therapy at this advanced stage of lung cancer includes systemic anti-cancer therapy such as chemotherapy, immunotherapy to boost the body's immune response, or targeted therapy that directly hinders tumor growth. In this study, the aim is to find out whether it is better if, after a good response to the standard therapy, the remains of main tumor and the metastases are additionally treated by surgery and/or radiation.
In this study, the aim is to find out whether, after a good response to standard therapy, it is better if the main tumor and metastases are additionally removed by surgery and/or radiation. This intervention is referred to as local ablative therapy (LAT). There is evidence to suggest that this additional intervention may prolong the average time to possible cancer recurrence (PFS: Progression-free survival) or lead to longer survival on average. Therefore, the question is to know if these treatments prolong life, and if so, by how much and with what implications. Currently, patients who respond to initial standard therapy are not routinely offered LAT. If the results of this study are positive, it will lead to a fundamental change in the current standard of practice. The benefit of a therapy is not solely determined by the extension of PFS or overall survival but also heavily influenced by how the therapy impacts patient's quality of life. Medication side effects, pain, fatigue, nausea or extended hospital stays can significantly diminish the perceived positive effects of a treatment from the patient's viewpoint, even if it appears favorable from a medical standpoint. Therefore, the assessment of quality of life through patient-reported outcome measures (PROMs) is a central aspect of this study. This study will enroll 128 patients from different Swiss hospitals, randomly assigning them to either the intervention group (LAT) or a control group (standard therapy). The study is expected to span approximately two years for each patient.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
128
The choice of LAT intervention for the primary tumor and all metastases (surgery or SBRT) and the sequence of the treatment (primary tumor vs metastases) will be decided at the local MDT according to the medical need and patient counseling during interdisciplinary clinic visits.
Surgery
Radiotherapy
Kantonspital Aarau
Aarau, Switzerland
RECRUITINGIOSI Ospedale Regionale di Bellinzona e Valli
Bellinzona, Switzerland
RECRUITINGKantonsspital Graubuenden
Chur, Switzerland
RECRUITINGHôpital Fribourgeois - Hôpital Cantonal
Fribourg, Switzerland
RECRUITINGHôpitaux Universitaires Genève HUG
Geneva, Switzerland
RECRUITINGLuzerner Kantonsspital
Lucerne, Switzerland
RECRUITINGUniversitätsspital Zürich
Zurich, Switzerland
RECRUITINGProgression-Free Survival (PFS) l in the Local Ablative Therapy (LAT) arm is superior to Standard of Care (SoC)
Progression free survival (PFS) will be assessed by regular clinical examinations of the patients and based on imaging modalities such as (PET)-CT scans and brain MRIs.
Time frame: up to 24 months after randomization
Quality of life (QoL) in the LAT arm is non-inferior to the control arm as measured with the European Quality of Life 5 Dimensions 3 Level (EQ-5D-5L) questionnaire-based score at 6 months after randomization
To show that QoL in the LAT arm is non-inferior to the control arm, mobility the European Quality of Life 5 Dimensions 3 Level (EQ-5D-5L) questionnaire will be used. The questionnaire uses an 1 (no problem) to 5 (extreme problems) scale.
Time frame: 6 months after randomization
Patients undergoing LAT maintain Quality of Life (QoL)
Patients undergoing LAT maintain Quality of Life (QoL) as measured by using the EQ-5D-5L on different time points of the trial.
Time frame: up to 24 months after randomization
To assess safety and tolerability of the LAT strategy as compared to standard of care
Safety to study interventions will be evaluated by measuring counts of serious adverse events from randomization until 30 days after last intervention or progression, whichever occurs first. Serious adverse events will be evaluated based on CTCAE v5.0.from randomization up until 30 days after last intervention.
Time frame: from randomization until 30 days after last intervention
To compare quality-adjusted life years
Quality-adjusted life years will be calculated based on the EQ-5D-5L scores and compared between treatment groups, as accrued during the trial observation period across all time points
Time frame: up to 24 months after randomization
To evaluate the economic impact of the LAT approach
The economic impact of the LAT approach will be calculated based on the costs of the LAT intervention and on the costs of healthcare utilization outside of the hospital. For the calculation of healthcare utilization costs, patients will be asked on scheduled visits about the healthcare services they have been using outside of the hospital.
Time frame: from signing informed consent until 24 months after randomization
To assess the response of primary tumor and metastases to systemic treatment alone and in combination with LAT (according to (i)RECIST criteria)
Time frame: from intervention until 24 month after randomization
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.