Patients With Non-small-cell Lung CancerPRIMERNCT06528743
Feasibility of Primer Shot Radiotherapy for Non-small Cell Lung Cancer - PRIMER
A study testing RT (5x6 Gy) to the primary tumor and, if indicated, to lymph node and/or distant metastases. in people with Patients With Non-small-cell Lung Cancer, run by The Netherlands Cancer Institute at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients With Non-small-cell Lung Cancer
- What is being tested?
- RT (5x6 Gy) to the primary tumor and, if indicated, to lymph node and/or distant metastases.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteNetherlands
- Study dates
- 8 Aug 2024to 1 Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Amsterdam
Zeno Gouw
About this study
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.
Read more
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.
- Conditions
- Patients With Non-small-cell Lung Cancer
- Being tested
- RT (5x6 Gy) to the primary tumor and, if indicated, to lymph node and/or distant metastases.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RT (5x6 Gy) to the primary tumor and, if indicated, to lymph node and/or distant metastases.Radiation
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.
| Study group | Role | What they receive |
|---|---|---|
| Primer shot treatment break of 1 week | Experimental | Patients receive an increasing primer shot treatment break. In arm 1, the break between the first and the second radiotherapy fraction is 1 week Receives: Radiation: RT (5x6 Gy) to the primary tumor and, if indicated, to lymph node and/or distant metastases. |
| Primer shot treatment break of 2 weeks | Experimental | Patients receive an increasing primer shot treatment break. In arm 1, the break between the first and the second radiotherapy fraction is 2 weeks Receives: Radiation: RT (5x6 Gy) to the primary tumor and, if indicated, to lymph node and/or distant metastases. |
| Primer shot treatment break of 3 weeks | Experimental | Patients receive an increasing primer shot treatment break. In arm 1, the break between the first and the second radiotherapy fraction is 3 weeks Receives: Radiation: RT (5x6 Gy) to the primary tumor and, if indicated, to lymph node and/or distant metastases. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%).
Measured: 5 weeks
Secondary outcomes (3)
Tumor response
the relative volume change after radiotherapy vs the CTRT.
Measured: 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)
Measured: from the first radiotherapy fraction until 6 months after radiotherapy
Patient-reported outcome patient-reported outcome- Common Terminology Criteria of Adverse Events (PRO)-CTCAE
Measured: up to 1 year after radiation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start8 Aug 2024
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Non-small-cell Lung CancerStudies of the same condition, open and under way.
- More trials run by The Netherlands Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Initially, patients are included following a 3+3 design to find the maximum tolerated break length, followed by an expansion cohort (unless there are already 2+ patients drop out in schedule 1, then there will be no expansion cohort).
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Netherlands Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06528743
- Sponsor's protocol ID
- N23PSR
- Acronym
- PRIMER
- Status last verified
- Jan 2025
- First submitted
- 26 Jul 2024
- Last updated
- 6 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Primer Shot Radiotherapy for Non-small Cell Lung Cancer - PRIMER
- ClinicalTrials.gov ID
- NCT06528743
- Acronym / sponsor ID
- PRIMER / N23PSR
- Conditions
- Patients With Non-small-cell Lung Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- The Netherlands Cancer InstituteUniversity, hospital or other
- Study start
- 8 Aug 2024 (actual)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 1 Aug 2029 (estimated)
- First posted
- 30 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Initially, patients are included following a 3+3 design to find the maximum tolerated break length, followed by an expansion cohort (unless there are already 2+ patients drop out in schedule 1, then there will be no expansion cohort).
| Arm | Type | Receives |
|---|---|---|
| Primer shot treatment break of 1 week | Experimental | 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 1 week |
| Primer shot treatment break of 2 weeks | Experimental | 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 |
| Primer shot treatment break of 3 weeks | Experimental | 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Radiation | Primer shot treatment break of 1 week, Primer shot treatment break of 2 weeks, Primer shot treatment break of 3 weeks |
Primary outcome
the ability of patients to finish the radiotherapy schedule
Time frame: 5 weeks
The study is powered to find a decrease of response from 99% to no less than 84.15% (relative decrease of 15%).
3 secondary outcomes
Tumor response
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RT (5x6 Gy) to the primary tumor and, if indicated, to lymph node and/or distant metastases. in people with Patients With Non-small-cell Lung Cancer, run by The Netherlands Cancer Institute at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zeno Gouw (+31205129111, z.gouw@nki.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the ability of patients to finish the radiotherapy schedule (time frame: 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2025.