Adding radiotherapy to standard treatment for advanced lung cancer
Multicentre Phase III Study: Addition of Radiotherapy to Standard Medical Treatment for Stage IV NSCLC
This study is testing if adding radiotherapy to the usual treatment for advanced lung cancer can help patients feel better and live longer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 162 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Swedish Lung Cancer Study Group Research network |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 3 sites (Umeå, Norrland and 2 other locations) |
| Trial ID | NCT04530708 on ClinicalTrials.gov |
What this trial studies
This study investigates whether adding a moderate dose of radiotherapy to the primary tumor and mediastinal nodes after three months of standard medical treatment can reduce tumor burden and improve quality of life for patients with stage IV non-small cell lung cancer (NSCLC). The primary objective is to assess quality of life using the lung cancer symptom scale (LCSS) three months after randomization. Patients will be randomly assigned to receive either thoracic radiotherapy or follow-up care. Secondary objectives include evaluating overall survival, progression-free survival, toxicity, and longitudinal quality of life measurements.
Who should consider this trial
Good fit: Ideal candidates are patients with histologically confirmed stage IV non-small cell lung cancer who are previously untreated and scheduled for standard chemotherapy or immunotherapy.
Not a fit: Patients with symptomatic brain metastases or those requiring daily supplemental oxygen may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the quality of life and potentially prolong survival for patients with advanced lung cancer.
How similar studies have performed: Other studies have shown promise in using radiotherapy in conjunction with systemic treatments for lung cancer, suggesting this approach may be beneficial.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Umeå, Norrland and 2 other locations
- Department of Oncology, Norrlands Universitetssjukhus — Umeå, Norrland, Sweden (Recruiting)
- Department of Oncology, Karolinska University Hospital — Stockholm, Stockholm County, Sweden (Not_yet_recruiting)
- Department of Oncology, Sahlgrenska University Hospital — Gothenburg, Västra Götaland, Sweden (Recruiting)
Study contacts
- Principal investigator: Jan Nyman, Ass.prof — Sahlgrenska University Hospital
- Study coordinator: Jan Nyman, Ass.prof.
- Email: jan.nyman@oncology.gu.se
- Phone: 0046313421000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.