Tests a radiotherapy schedule with a pause in adults with lung cancer
Tests radiotherapy with a pause after the first dose in lung cancer.
Plain-language title generated from the registry record
Registry title: Feasibility of Primer Shot Radiotherapy for Non-small Cell Lung Cancer - PRIMER
Key facts
- Where
- Amsterdam, NetherlandsSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with non-small cell lung cancer (NSCLC) who are referred for palliative radiotherapy. It tests a first radiotherapy dose followed by a treatment break.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- NSCLC stage 2-4, proven by pathology or strongly suspected clinically; referred for palliative radiotherapy of at least the primary tumor; WHO performance score 0-2
- Earlier treatment
- Systemic treatments are allowed, except VEGFR inhibitors. Prior chest radiotherapy of more than 20 Gy EQD2 a/b 3 overlapping with the planned treatment area is not allowed.
Main reasons for not taking part
- Interstitial lung disease
- Treatment with VEGFR inhibitors
- Prior chest radiotherapy (>20 Gy EQD2 a/b 3) overlapping with the planned treatment area
Read by machine on 12 November 2026.
Where in Netherlands
- Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis StichtingAmsterdam, NetherlandsContact: Zeno GouwTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- The Netherlands Cancer Institute
- Trial code
- NCT06528743
- Record updated
- 6 January 2025
- Original description
Intro/rationale: Radiotherapy employs uniform, equally spaced weekday fractions that do not account for changes in tumor radiosensitivity. However, radiobiological characteristics evolve during the radiotherapy schedule as reoxygenation increases radiosensitivity. In tumor-response simulations and preclinical experiments, it was superior to prime the tumor with one radiotherapy fraction, followed by a treatment break permitting mitotic cell death and reoxygenation of tumor cells.Read full original descriptionShow less
Feasibility of Primer Shot Radiotherapy for Non-small Cell Lung Cancer - PRIMER
Intro/rationale: Radiotherapy employs uniform, equally spaced weekday fractions that do not account for changes in tumor radiosensitivity. However, radiobiological characteristics evolve during the radiotherapy schedule as reoxygenation increases radiosensitivity. In tumor-response simulations and preclinical experiments, it was superior to prime the tumor with one radiotherapy fraction, followed by a treatment break permitting mitotic cell death and reoxygenation of tumor cells.
Objective: To determine the safety and feasibility of primer shot fractionation for NSCLC.
Study design: A prospective non-randomized feasibility trial to test the safety of primer shot fractionation in a 3+3 phase with increasing treatment breaks, followed by an expansion cohort.
Study population: Patients with NSCLC stage 2-4, referred for palliative radiotherapy of the primary tumor and possibly (lymph node) metastases. Patients are allowed to receive systemic treatments, except for VEGFR-inhibitors. The 3+3 phase is followed by an expansion phase of 22 patients.
Intervention: All treatments are 5x6 Gy to all targets. Patients receive an increasing primer shot treatment break. In the 3+3 phase, the break between the first and the second radiotherapy fraction is: 1, 2 and 3 weeks. The maximum tolerated break length will be used for the expansion cohort.
Main study parameters/endpoints: The main study endpoint is the ability of patients to finish the radiotherapy schedule as planned. Secondary endpoints are tumor response at the end of treatment and 3 months thereafter, and acute toxicity.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Based on simulations and preclinical data, primer shot treatment breaks increase tumor control. However, the increased overall treatment time could potentially increase the chance a patient drops out before the radiotherapy schedule is finished. Because of the gradually prolonged break, this risk is relatively small and acceptable for this population. Additionally, patients are asked to fill in PRO-CTCAE lung subset questionnaires at the start of treatment and during follow-up. They will also receive 1 additional CT with contrast at fraction 5.
Inclusion: 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: 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; Interstitial lung disease.