Testing a new radiotherapy approach for non-small cell lung cancer
Feasibility of Primer Shot Radiotherapy for Non-small Cell Lung Cancer - PRIMER
This study is testing a new way of giving radiotherapy to see if it helps people with advanced non-small cell lung cancer feel better by using breaks in treatment to make the tumors more sensitive to the radiation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 34 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Netherlands Cancer Institute Academic / other |
| Locations | 1 site (Amsterdam) |
| Trial ID | NCT06528743 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and feasibility of a novel radiotherapy technique called primer shot fractionation for patients with non-small cell lung cancer (NSCLC). The approach involves administering an initial radiotherapy fraction followed by a treatment break to enhance tumor radiosensitivity through reoxygenation. The trial is designed as a prospective non-randomized feasibility study, utilizing a 3+3 phase design to assess increasing treatment breaks and includes an expansion cohort for further evaluation. Patients with stage 2-4 NSCLC who are referred for palliative radiotherapy will be included in the study.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with stage 2-4 non-small cell lung cancer referred for palliative radiotherapy.
Not a fit: Patients with interstitial lung disease or those who have received prior thoracic radiotherapy overlapping with the current treatment plan may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve treatment outcomes for patients with advanced non-small cell lung cancer by enhancing the effectiveness of radiotherapy.
How similar studies have performed: While this approach is innovative, similar studies have not been widely reported, indicating that this may be a novel exploration in the field.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years * NSCLC (either pathology proven or sufficient clinical suspicion to be treated as NSCLC), referred for palliative radiotherapy of at least the primary tumor site. * Stage 2-4 * WHO performance score 0-2. * Provision of signed, written and dated IC prior to any study specific procedures. Exclusion Criteria: * Interstitial lung disease * Treatment with vascular endothelial growth factor receptor (VEGFR) inhibitors * Prior thoracic radiotherapy (\>20 Gy EQD2 a/b 3) overlapping with the current planning target volume
Where this trial is running
Amsterdam
- Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting — Amsterdam, Netherlands (Recruiting)
Study contacts
- Study coordinator: Zeno Gouw
- Email: z.gouw@nki.nl
- Phone: +31205129111
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.