An interventional study of RT (5x6 Gy) to the primary tumor and, if indicated, to lymph node and/or distant metastases. in Patients With Non-small-cell Lung Cancer, sponsored by The Netherlands Cancer Institute. Recruiting at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-06.
Sponsored by The Netherlands Cancer Institute · Not applicable, Interventional, and Treatment
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.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's planned enrollment of 34 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →The Netherlands Cancer Institute is the lead sponsor of 224 studies on the registry; 66 are open to participants now.
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Exclusion Criteria:
Patients receive an increasing primer shot treatment break. In arm 1, the break between the first and the second radiotherapy fraction is 1 week
Radiation: RT (5x6 Gy) to the primary tumor and, if indicated, to lymph node and/or distant metastases.
Patients receive an increasing primer shot treatment break. In arm 1, the break between the first and the second radiotherapy fraction is 2 weeks
Radiation: RT (5x6 Gy) to the primary tumor and, if indicated, to lymph node and/or distant metastases.
Patients receive an increasing primer shot treatment break. In arm 1, the break between the first and the second radiotherapy fraction is 3 weeks
Radiation: RT (5x6 Gy) to the primary tumor and, if indicated, to lymph node and/or distant metastases.
Patients will receive RT (5x6 Gy) to the primary tumor and, if indicated, to lymph node and/or distant metastases. Enrolled patients will receive a fractionation scheme with increasing break length.
the ability of patients to finish the radiotherapy schedule
The study is powered to find a decrease of response from 99% to no less than 84.15% (relative decrease of 15%).
Time frame: 5 weeks
Tumor response
the relative volume change after radiotherapy vs the CTRT.
Time frame: at the end of treatment and after 3 months
treatment associated ≥ grade 2 non-hematologic toxicity according to the NCI Common Terminology Criteria of Adverse Events (CTCAE version 5.0) (from the first radiotherapy fraction until 6 months after radiotherapy)
Time frame: from the first radiotherapy fraction until 6 months after radiotherapy
Patient-reported outcome patient-reported outcome- Common Terminology Criteria of Adverse Events (PRO)-CTCAE
Time frame: up to 1 year after radiation.
Plan to share: Undecided
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The Netherlands Cancer Institute