Observational study on palliative thoracic radiotherapy for advanced lung cancer patients receiving immunotherapy
Evaluation of Toxicities With Thoracic Radiotherapy and Immune Checkpoint Inhibition in Non-small Cell Lung Cancer
This study is testing whether adding radiation therapy to immunotherapy helps people with advanced lung cancer feel better and improve their treatment results.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Health Network, Toronto Academic / other |
| Drugs / interventions | nivolumab, pembrolizumab, chemotherapy |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT03705806 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients with stage IV non-small cell lung cancer who are being treated with PD-1 inhibitors, such as nivolumab or pembrolizumab. Participants will receive palliative thoracic radiotherapy at a standard dose of 30 Gy in 10 fractions. The study aims to evaluate the outcomes of this combined treatment approach in a real-world setting. It will involve monitoring patient-reported outcomes and overall treatment responses.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 or older with pathologically confirmed stage IV adenocarcinoma or squamous cell carcinoma who are not eligible for curative treatment.
Not a fit: Patients with contraindications to radiotherapy or those who have previously experienced severe side effects from checkpoint inhibitors may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve the quality of life and treatment outcomes for patients with advanced lung cancer.
How similar studies have performed: Other studies have shown promising results with similar combinations of immunotherapy and palliative radiotherapy, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Pathologically confirmed AJCC 7th/8th edition Stage IV adenocarcinoma or squamous cell carcinoma not eligible for curative treatment. 2. Indication and suitability to receive palliative radiotherapy to the thorax (30Gy/10). 3. Receiving or planned to receive nivolumab or pembrolizumab 4. Prior history of systemic chemotherapy is permitted given a washout period of 4 weeks 5. Age 18 or older 6. ECOG Performance Status 0-2 7. Life expectancy greater than 3 months 8. Able and willing to provide informed consent 9. Able to complete patient reported outcome questionnaires Exclusion Criteria: 1. Contraindications to radiotherapy, including a history of SLE, systemic scleroderma, IPF, ataxia telangiectasia 2. Previous history of thoracic radiotherapy with an overlapping field 3. Previous history of checkpoint inhibitor related pneumonitis or esophagitis 4. Pregnancy
Where this trial is running
Toronto, Ontario
- University Health Network, Princess Margaret Cancer Centre — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Alex Sun, MD
- Email: alex.sun@rmp.uhn.ca
- Phone: 416-946-4501
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.