Radiotherapy for Keloids

Recruiting at 1 trial location

Overseen By Daniel Alicea

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Montefiore Medical Center

Disqualifiers: Prior RT overlap, Pregnancy, Uncontrolled illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether radiation therapy can safely and effectively treat keloids that cannot be removed with surgery. Keloids are thick, raised scars that some people develop after an injury. The study focuses on patients with keloids that cannot be surgically removed or who prefer not to undergo surgery. Those with a keloid fitting this description and who have not had radiation in the same area may qualify for this trial. As an Early Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.

Do I need to stop my current medications for the keloid radiotherapy trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that radiotherapy is likely to be safe for humans?

Research has shown that radiotherapy, often used after surgery, can help prevent keloids from returning. For example, one study found that only about 10.4% of keloid sites treated with radiotherapy after surgery showed new growth within a year.

However, most current evidence focuses on using radiotherapy after surgical removal of keloids. Less information is available about the safety of using radiotherapy on keloids that remain intact.

This trial is in an early stage, primarily aiming to ensure the treatment's safety. Early-stage trials typically involve small groups to closely monitor how participants handle the treatment and identify any side effects. Although radiotherapy is approved for other uses, specific data is still needed for treating keloids that cannot be removed. Participants should discuss the possible risks and benefits with the study team. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for keloids?

Radiotherapy for keloids is unique because it uses targeted radiation to treat scar tissue that is difficult to remove surgically. Unlike traditional treatments such as corticosteroid injections or surgical excision, radiotherapy offers a non-invasive approach that can be tailored to individual patients using electron beam or high dose-rate brachytherapy. Researchers are excited about this method because it delivers a precise dose of radiation directly to the keloid, potentially reducing recurrence and improving outcomes without the need for surgery.

What evidence suggests that radiotherapy might be an effective treatment for keloids?

Studies have shown that radiation therapy can help treat keloids. One study found that 78.6% of keloids became completely flat when treated only with radiation. This indicates that radiation can significantly reduce keloid size even without surgery. In this trial, participants with nonresectable keloids will receive radiotherapy as a standalone treatment. Although most research suggests that radiation works best immediately after surgical removal of the keloid, using radiation alone offers a promising option for those unable to undergo surgery. ^{1 2 6 7 8}

Who Is on the Research Team?

Keyur J Mehta, MD

Principal Investigator

Montefiore

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Study specific informed consent provided

I have a keloid that cannot be or I refuse to have surgically removed.

Exclusion Criteria

I am of childbearing age and will take a pregnancy test before radiation or use birth control during treatment.

I do not have any severe illnesses that my doctor thinks could interfere with the study.

My doctor says keloids where I'd get radiation could cause too much harm.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive radiation therapy with a dose of 15 Gy divided into 5 Gy fractions over 3 consecutive days

1 week

3 visits (in-person)

Follow-up

Participants are monitored for treatment-related toxicities and response, including cessation of growth or shrinkage of keloids, and quality of life assessments

Up to 1 year

Frequent visits (in-person) for up to 1 year

What Are the Treatments Tested in This Trial?

Interventions

• Radiotherapy

Trial Overview 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.

How Is the Trial Designed?

Group I: Radiotherapy for patients with nonresectable keloids Experimental Treatment 1 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.

Radiotherapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Radiation therapy for:

• Various cancers including breast cancer, lung cancer, prostate cancer, and soft tissue sarcoma

Approved in United States as Radiation therapy for:

• Various cancers including breast cancer, lung cancer, prostate cancer, and soft tissue sarcoma

Approved in Canada as Radiation therapy for:

• Various cancers including breast cancer, lung cancer, prostate cancer, and soft tissue sarcoma

Approved in Japan as Radiation therapy for:

• Various cancers including breast cancer, lung cancer, prostate cancer, and soft tissue sarcoma

Approved in China as Radiation therapy for:

• Various cancers including breast cancer, lung cancer, prostate cancer, and soft tissue sarcoma

Approved in Switzerland as Radiation therapy for:

• Various cancers including breast cancer, lung cancer, prostate cancer, and soft tissue sarcoma

Who Is Running the Clinical Trial?

Montefiore Medical Center

Lead Sponsor

Trials

468

Recruited

599,000+

Published Research Related to This Trial

Postoperative carbon ion radiotherapy demonstrated a 95% success rate in treating keloids among 16 patients over an average follow-up of 29.7 months, indicating its efficacy as a treatment option.

The treatment was well tolerated with no severe toxicity (grade 3 or higher) reported, suggesting a favorable safety profile for this approach in managing keloids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative carbon ion radiotherapy for keloids: a preliminary report of 16 cases and review of the literature. Chen, Y., Dong, F., Wang, X., et al.[2015]

External beam radiotherapy after keloid excision is effective in preventing keloid relapse, with 60% of patients reporting high satisfaction levels (8 or above on a scale of 1-10).

The treatment is generally well tolerated, with common early toxicities like skin redness (54.2%) and peeling (24%), and late toxicities including telangiectasia (27%) and permanent skin color changes (62%), but these did not significantly correlate with patient demographics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Descriptive study of patients receiving excision and radiotherapy for keloids. Speranza, G., Sultanem, K., Muanza, T.[2015]

Postoperative radiotherapy significantly reduces keloid recurrence rates compared to radiotherapy alone, with a recurrence rate of 22% for combined treatment versus 37% for radiotherapy alone.

Among different radiation modalities, brachytherapy is the most effective, showing a recurrence rate of only 15%, while X-ray and electron beam treatments had higher rates of 23%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing Radiotherapy for Keloids: A Meta-Analysis Systematic Review Comparing Recurrence Rates Between Different Radiation Modalities. Mankowski, P., Kanevsky, J., Tomlinson, J., et al.[2022]

Electron beam irradiation for keloids shows an impressive control rate of 84% with minimal side effects, making it a highly effective treatment option.

After a mean follow-up of 7.2 years, no severe side effects or malignancies were reported, indicating a strong safety profile for this therapy compared to kilovoltage X-ray treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiotherapy in the management of keloids. Clinical experience with electron beam irradiation and comparison with X-ray therapy. Maarouf, M., Schleicher, U., Schmachtenberg, A., et al.[2019]

A study of 2,515 resected keloids found that postoperative external beam radiotherapy (XRT) significantly reduces recurrence rates, especially for keloids located on the earlobe, which had a much lower recurrence risk (odds ratio 0.34).

The research indicates that using higher doses of radiation (15 Gy total, with 5 Gy per fraction) and specific techniques like electron beam or Co-60 is more effective, with optimal doses needed for controlling keloids being around 16-19 Gy for earlobe keloids and higher for others.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A radiobiological analysis of multicenter data for postoperative keloid radiotherapy. Flickinger, JC.[2022]

Radiotherapy is increasingly recognized as an effective adjuvant treatment for large or stubborn keloids following surgical excision, enhancing the overall management of this condition.

Dermatologists should be knowledgeable about radiotherapy techniques to improve patient outcomes for those suffering from difficult-to-treat keloids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

RADIATION THERAPY for the Adjunctive Treatment of Surgically Excised Keloids: A Review. Cheraghi, N., Cognetta, A., Goldberg, D.[2022]

Superficial x-ray therapy is effective in reducing the recurrence of keloids after surgical excision, as demonstrated in a retrospective study of 24 patients, which aligns with findings from 18 other studies.

While there is some concern about the safety of radiotherapy for keloids, only one questionable case of carcinoma has been reported following treatment, suggesting that the risk may be low, but further controlled studies are needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Superficial x-ray therapy in keloid management: a retrospective study of 24 cases and literature review. Norris, JE.[2019]

In a study of 70 patients treated with either low-dose-rate (LDR) or high-dose-rate (HDR) brachytherapy after keloid surgery, both treatments showed similar recurrence rates of keloids, with 30.4% for LDR and 38% for HDR, indicating that both methods are effective options for preventing keloid recurrence.

HDR brachytherapy provided better symptomatic relief, with 92% of patients experiencing relief compared to 68% in the LDR group, suggesting that HDR may be more beneficial for managing keloid-related symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative management of keloids: low-dose-rate and high-dose-rate brachytherapy. De Cicco, L., Vischioni, B., Vavassori, A., et al.[2022]

Radiotherapy, particularly brachytherapy, has evolved as an effective treatment for keloids, but there is still no consensus on the best strategies for its use, including timing, dose, and treatment frequency.

This review compiles existing literature on adjuvant radiotherapy for keloids, highlighting important factors that may influence treatment outcomes and complications, which can aid clinicians in making informed decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adjuvant Radiotherapy for Keloids. Dong, W., Qiu, B., Fan, F.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7840087/

A Retrospective Registry Study Evaluating the Long-Term ... RESULTS: Ten treated keloidectomy sites (10.4%) had recurrences (i.e., presence of any new tissue growth on the surgical scar) within 12 months ...

2. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK499973/

Radiation Therapy in the Treatment of Keloids - NCBI - NIH Radiation starting on the same day after surgical removal of the keloid is most effective. This usually requires coordinated care between the surgeon and ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1748681522002807

Review Radiation therapy modalities for keloid management A number of studies have suggested that post-excisional radiation therapy can reduce rates of keloid recurrence. However, existing reports span multiple ...

4. thegreenjournal.com thegreenjournal.com/article/S0167-8140(22)04148-2/abstract

Effect of the biologically effective dose of electron beam ... Adjuvant electron beam radiation therapy after keloid excision has been proven as highly effective in reducing local recurrence.

5. clinicaloncologyonline.net clinicaloncologyonline.net/article/S0936-6555(24)00116-X/fulltext

A Single-Institution Review of the Use of Radiation in ... We demonstrate a complete keloid flattening rate of 78.6% for keloids treated with definitive radiation therapy. •. We describe our treatment ...

6. systematicreviewsjournal.biomedcentral.com systematicreviewsjournal.biomedcentral.com/articles/10.1186/s13643-023-02192-7

Keloid treatments: an evidence-based systematic review of ... Surgical excision followed by radiation therapy has been showed to be highly effective at reducing recurrence (Table 6). Reduction in fibroblast ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7882325/

Prophylactic external beam radiation therapy for keloid ... Patients in the adjuvant EBRT group showed higher keloid remission rate and were more satisfied with their cosmetic outcome compared to the cryotherapy and ...

8. jcadonline.com jcadonline.com/radiation-therapy-keloid-scars/

A Retrospective Registry Study Evaluating the Long-Term ... To confirm the effectiveness of x-ray therapy following the surgical removal of keloid scars, the following retrospective study assessed the rate of keloid scar ...