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Radiation Therapy

Radiotherapy for Keloids

Phase < 1
Waitlist Available
Led By Jonathan Klein, MD
Research Sponsored by Montefiore Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥18
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year post radiotherapy
Awards & highlights

Study Summary

This trial is testing whether radiation therapy is a safe and effective treatment for keloids that can't be removed by surgery.

Who is the study for?
This trial is for adults with clinically diagnosed keloids that can't be or haven't been removed by surgery. It's open to those who have had keloids return after previous resection, as long as the current one isn't suitable for surgery or they've refused it. Women must not be pregnant and willing to use contraception during the study.Check my eligibility
What is being tested?
The trial is testing radiation therapy (RT) on unresected keloids to see if it's safe and works well. This pilot study will involve patients receiving RT instead of surgical removal of their keloids, monitoring them for results.See study design
What are the potential side effects?
Potential side effects from radiation therapy may include skin irritation, changes in skin color, fatigue, and a slight risk of secondary cancers in the treated area. The specific risks can vary based on individual patient factors.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year post radiotherapy
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year post radiotherapy for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Treatment-related toxicities
Secondary outcome measures
Cessation of growth or shrinkage of keloids
Quality of Life as determined by SKINDEX-16 questionnaire

Side effects data

From 2016 Phase 3 trial • 854 Patients • NCT00003389
98%
Anemia
93%
Leukocytes decreased
90%
Lymphopenia
84%
Neutrophils decreased
78%
Neuropathy-sensory
75%
Alopecia
74%
Fatigue
67%
Nausea
60%
Hyperglycemia
52%
Constipation
46%
Hypoalbuminemia
40%
Myalgia
34%
Stomatitis
33%
Insomnia
32%
Vomiting
27%
Platelets decreased
26%
Alkaline phosphatase increased
26%
Aspartate aminotransferase increased
23%
Dyspnea
20%
Dyspepsia
19%
Dysphagia
19%
Headache
16%
Anorexia
16%
Arthralgia
15%
Neuropathy-motor
15%
Abdominal pain
14%
Infection w/o neutropenia
14%
Cough
14%
Fever
13%
Rash/desquamation
13%
Diarrhea w/o prior colostomy
12%
Bone pain
11%
Weight gain
11%
Taste disturbance
11%
Anxiety/agitation
10%
Sweating
10%
Radiation dermatitis
9%
Rigors/chills
9%
Dizziness/lightheadedness
9%
Injection site reaction
8%
Hypoglycemia
8%
Dysphagia-esophageal radiation
8%
Blood bilirubin increased
8%
Chest pain
8%
Pain-other
8%
Phlebitis
7%
Creatinine increased
7%
Edema
7%
Pruritus
6%
Hot flashes
6%
Infection w/ grade 3 or 4 neutropenia
6%
Weight loss
5%
Muscle weakness
5%
Depression
5%
Mouth dryness
4%
Transfusion: pRBCs
4%
Pneumonitis/pulmonary infiltrates
3%
Thrombosis/embolism
3%
Febrile neutropenia
3%
Irregular menses
3%
Nail changes
2%
Allergic rhinitis
1%
Allergic reaction
1%
Infection w/ unknown ANC
1%
Syncope
1%
Sinus tachycardia
1%
Dehydration
1%
Neuropathic pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm B (Stanford V)
Arm A (ABVD)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Radiotherapy for patients with nonresectable keloidsExperimental Treatment1 Intervention
Patients will be seen by a treating radiation oncologist and treatment with the assigned dose schedule will be planned using either EBRT with electrons or high dose-rate radiotherapy (HDR) brachytherapy as deemed appropriate by the treating radiation oncologist. The treatment dose of 15 Gy in 3 fractions will be prescribed to the 90% isodose line.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiotherapy
2017
Completed Phase 3
~2610

Find a Location

Who is running the clinical trial?

Montefiore Medical CenterLead Sponsor
441 Previous Clinical Trials
582,181 Total Patients Enrolled
Jonathan Klein, MDPrincipal Investigator - Montefiore
Montefiore Medical Center
Keyur J Mehta, MDPrincipal InvestigatorMontefiore

Media Library

Radiotherapy (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04722263 — Phase < 1
Keloid Research Study Groups: Radiotherapy for patients with nonresectable keloids
Keloid Clinical Trial 2023: Radiotherapy Highlights & Side Effects. Trial Name: NCT04722263 — Phase < 1
Radiotherapy (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04722263 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there opportunities for further enrolment in this research project?

"The details on clinicaltrials.gov indicate that this trial is actively seeking participants, having been first uploaded to the platform on December 1st 2020 and last adjusted on November 10th 2022."

Answered by AI

What is the approximate size of the pool participating in this clinical experiment?

"Affirmative. Clinicaltrials.gov confirms that this clinical trial, which was initially published on December 1st 2020, is actively looking for volunteers to join. 15 participants are needed from a single site."

Answered by AI

Who else is applying?

What site did they apply to?
Montefiore Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1

What questions have other patients asked about this trial?

Would like to know the schedule for screening, like what time and day does it usually take place and is there some flexibility?
PatientReceived 2+ prior treatments

Why did patients apply to this trial?

Trying to find ways to treat the multiple keloids, that have hindered my life.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Radiotherapy for Keloids
Keyur J Mehta 2020. "Radiotherapy for Keloids". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04722263.
All > Keloid
~2 spots leftby Dec 2024
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