Ignite Creation Date:
2024-07-17 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06484491
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-06-17
Brief Title:
IMPT Dose Escalation for NSCLC HyDose
Sponsor:
University Medical Center Groningen
Organization:
University Medical Center Groningen
Study Overview
Official Title:
Radiotherapy Dose Escalation Using Intensity-modulated Proton Therapy for Non-small-cell Lung Cancer Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HyDose
Brief Summary:
In this randomized controlled trial the aim is to test the hypothesis that proton therapy dose escalation using a heterogeneous simultaneous boost on the primary tumor as part of chemoradiotherapy for locally advanced non-small-cell lung cancer is safe ie does not result in an increase in severe toxicity compared to standard-dose proton therapy Secondarily the goal is to estimate the treatment effect size if any
In the intervention group patients will receive intensity-modulated proton therapy dose escalation to the primary tumor up to 740 Gy or 640 Gy RBE of 11 in 25 fractions depending on proximity to the mediastinal envelope In the control group patients will receive 600 Gy intensity-modulated proton therapy in 25 fractions
In the intervention group patients will receive intensity-modulated proton therapy dose escalation to the primary tumor up to 740 Gy or 640 Gy RBE of 11 in 25 fractions depending on proximity to the mediastinal envelope In the control group patients will receive 600 Gy intensity-modulated proton therapy in 25 fractions
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NL8643504224 | OTHER | None | None |