Non Small Cell Lung Cancer, Quality of Life, Radiotherapy, Stage IV Non-small Cell Lung Cancer
Conditions
Keywords
NSCLC, Radiotherapy, Quality of life
Brief summary
The hypothesis for this study is that addition of a moderate dose of radiotherapy to the primary tumor and mediastinal nodes after three months of medical treatment could reduce the tumor burden, partly as an abscopal effect, and thereby improving quality of life and possible also prolonging survival for stage IV NSCLC.
Detailed description
Primary objective: To assess whether the addition of radiotherapy to the remaining thoracic tumor burden following standard medical treatment results in a superior quality of life measured with lung cancer symptom scale (LCSS) in patients with stage IV non-small cell lung cancer. The comparison will be made at three months after randomization. Secondary objectives: Overall survival, progression-free survival, toxicity and longitudinal quality of life measurements. Design: Multicentre, randomized, phase III trial. Patients will be registered for the study up-front but randomization will be performed after evaluation of response, three months after initiating medical treatment with chemotherapy/ chemo-immunotherapy or immunotherapy. Randomization will be to thoracic radiotherapy or follow-up (1:1).
Interventions
RADIATIONThoracic radiotherapy
36 Gy to the primary lung tumor and present mediastinal node metastases after three months of medical treatment.
Sponsors
Swedish Lung Cancer Study Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Multicentre randomized phase 3 trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histological or cytological confirmed non-small cell lung cancer (NSCLC) * Stage IV disease * Previously untreated disease (before first line treatment) * No symptomatic brain metastases * Performance status (WHO) 0-2 * FEV1 (forced expiratory volume one second) ≥ 1 L or \>40% of predicted * Written informed consent * Life expectancy ≥ 12 weeks * Platelet count ≥ 100,00/mm3 * Hemoglobin ≥ 10 g/dl * WBC (White blod cells) ≥ 3,000/mm3 * Kidney function allowing chemotherapy * Patients scheduled for standard platinum based chemotherapy, chemo-immunotherapy or immunotherapy * Willing and able to comply with study treatment
Exclusion criteria
* Requirement for daily supplemental oxygen * Second primary malignancy within 3 years, except for any of the following which can be included even if diagnosed within the past 3 years: Carcinoma in situ of the cervix, nonmelanoma skin cancer, history of low-grade (Gleason score ≤ 6) localized prostate cancer, definitely treated stage I breast cancer, other malignancy that was diagnosed and definitely treated ≥ 3 years ago with no subsequent evidence of recurrence * Concurrent severe and/or uncontrolled medical condition, including any of the following: * Angina pectoris * Congestive heart failure within the past 3 months, unless LVEF (left ventricular ejection fraction) \> 40% * Myocardial infarction within the past 6 months * Clinically significant infection * Psychiatric illness or social situation that would limit compliance with study requirements * EGFR (epidermal growth factor receptor) mutation or ALK (anaplastic lymphoma kinas) - rearrangement detected
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in quality of life | Three months after randomization | LCSS, lung cancer symptom scale. A scale from zero to one-hundred, higher number indicate worse symptoms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 24 months | From randomization |
| Progression free survival | 24 months | From randomization |
| Toxicity of esophagitis, pneumonitis, dyspnea, fatigue, cough | During follow-up , up to 24 months. | CTC (common toxicity criteria) version 4.0. Esophagitis, pneumonitis, dyspnea, fatigue, cough, worst grade. |
Countries
Sweden
Contacts
Primary ContactJan Nyman, Ass.prof.
Backup ContactAndreas Hallqvist, MD, PhD
Outcome results
None listed