Ignite Creation Date:
2024-05-06 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04722263
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-12-12
First Post:
2021-01-08
Brief Title:
Radiotherapy for Keloids
Sponsor:
Montefiore Medical Center
Organization:
Montefiore Medical Center
Study Overview
Official Title:
Primary Radiotherapy for the Treatment of Keloids A Pilot Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-12
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:
None
Brief Summary:
The purpose of this pilot study is to evaluate the safety and efficacy of radiation therapy RT in the treatment of unresected keloids
Detailed Description:
This will be a single-institution pilot study to evaluate the safety and efficacy of radiation therapy RT for the treatment of unresected keloids The primary endpoint will be toxicity within 10 weeks of follow-up Secondary endpoints will include cessation of growth or shrinkage of keloids symptomatic response and impact on quality of life
Primary Objective
-evaluate feasibility and safety of radiation therapy only for the treatment of unresected keloids
Secondary Objectives
To evaluate toxicity of RT for the treatment of unresected keloids
To evaluate response of keloids either stability or decrease in size after primary RT
To evaluate symptomatic response of unresected keloids to primary RT
To assess the effect on quality of life of primary RT for unresected keloids After review of the literature on the use of RT for the treatment of keloids both resected and unresected as well as input of expert opinion and clinical experience by the studys radiation oncologists the RT prescription dose for this study was selected to be 15 Gy which will be divided into 5 Gy fractions delivered daily over on 3 consecutive days
Patients will receive RT using external beam radiotherapy EBRT delivered via either electrons or megavoltage photons or brachytherapy RT modality will be based on the judgment of the treating radiation oncologist We estimate we will be able to recruit 15-20 patients in 6-12 months thus we are aiming for a sample size of 15 patients In successive intervals of enrollment and treatment of 5 patients ie after 5 10 and 15 patients have been enrolled the study team will meet and perform interim analysis to evaluate the safety and efficacy of treatment Investigators will discuss rates of toxicity and symptom management observed up to that point and determine if the study dose or protocol needs to be altered
Patients will be evaluated frequently for treatment-related toxicities using CTCAE v50 up to 1 year after completion of RT Any adverse event will be considered by the study investigators to evaluate the safety of the protocol and to determine whether changes to the dosing regimen are required
Primary Objective
-evaluate feasibility and safety of radiation therapy only for the treatment of unresected keloids
Secondary Objectives
To evaluate toxicity of RT for the treatment of unresected keloids
To evaluate response of keloids either stability or decrease in size after primary RT
To evaluate symptomatic response of unresected keloids to primary RT
To assess the effect on quality of life of primary RT for unresected keloids After review of the literature on the use of RT for the treatment of keloids both resected and unresected as well as input of expert opinion and clinical experience by the studys radiation oncologists the RT prescription dose for this study was selected to be 15 Gy which will be divided into 5 Gy fractions delivered daily over on 3 consecutive days
Patients will receive RT using external beam radiotherapy EBRT delivered via either electrons or megavoltage photons or brachytherapy RT modality will be based on the judgment of the treating radiation oncologist We estimate we will be able to recruit 15-20 patients in 6-12 months thus we are aiming for a sample size of 15 patients In successive intervals of enrollment and treatment of 5 patients ie after 5 10 and 15 patients have been enrolled the study team will meet and perform interim analysis to evaluate the safety and efficacy of treatment Investigators will discuss rates of toxicity and symptom management observed up to that point and determine if the study dose or protocol needs to be altered
Patients will be evaluated frequently for treatment-related toxicities using CTCAE v50 up to 1 year after completion of RT Any adverse event will be considered by the study investigators to evaluate the safety of the protocol and to determine whether changes to the dosing regimen are required
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None