Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06528743
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-26
Brief Title:
Feasibility of Primer Shot Radiotherapy for Non-small Cell Lung Cancer - PRIMER
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Feasibility of Primer Shot Radiotherapy for Non-small Cell Lung Cancer - PRIMER
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRIMER
Brief Summary:
Introrationale 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 33 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 33 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 33 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 parametersendpoints 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
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 33 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 33 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 33 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 parametersendpoints 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None