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Feasibility of primer shot radiotherapy for non-small cell lung cancer (PRIMER)

Feasibility of primer shot radiotherapy for non-small cell lung cancer (PRIMER) - PRIMER

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON56897
Enrollment
35
Registered
2024-07-29
Start date
2024-11-08
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small cell lung cancer non-small-cell lung cancer

Interventions

All treatments are 5x6 Gy to all targets. Patients receive an increasing primer shot treatment break. In the 3+4 phase, the break between the first and the second radiotherapy fraction is: 1, 2 and

Sponsors

Antoni van Leeuwenhoek Ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion 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 (to eleviate or prevent symptoms like shortness of breath, coughing, pain or hemoptysis). • NSCLC, stage 2-4 • WHO performance score 0*2. • Provision of signed, written and dated IC prior to any study specific procedures.

Exclusion criteria

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 • Pregnant

Design outcomes

Primary

MeasureTime frame
The main study endpoint is whether patients finish the radiotherapy schedule as planned (completion of all 5 fractions and two or less additional unplanned days between fractions).

Secondary

MeasureTime frame
Secondary endpoints are tumor response at the end of treatment and 3 months thereafter, and acute toxicity.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)