Radiotherapy for Keloids

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

Trial Summary

What is the purpose of this trial?

The purpose of this pilot study is to evaluate the safety and efficacy of radiation therapy (RT) in the treatment of unresected keloids.

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.

What data supports the effectiveness of the treatment Radiotherapy for Keloids?

Research shows that radiotherapy, when used after surgical removal of keloids, can help reduce the chance of the keloids coming back. It has been used successfully for other skin conditions, and studies suggest it can be a helpful addition to surgery for treating stubborn keloids. ^{1 2 3 4 5}

Is radiotherapy safe for treating keloids?

Radiotherapy for keloids has been used since 1906, and while it is generally effective in reducing recurrence, there is no consensus on its safety. There has been only one questionable case of cancer reported after keloid treatment with radiotherapy, suggesting it is generally safe, but long-term follow-up is recommended. ^{1 6 7 8 9}

How is radiotherapy different from other treatments for keloids?

Radiotherapy is unique for keloids as it is used after surgical removal to prevent them from coming back, unlike other treatments that might not involve surgery. It uses high-energy rays to target the area, which is different from creams or injections that are applied directly to the skin. ^{1 3 4 6 8}

Research Team

Keyur J Mehta, MD

Principal Investigator

Montefiore

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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, 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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

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

2. United States pubmed.ncbi.nlm.nih.gov

Adjuvant Radiotherapy for Keloids. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

RADIATION THERAPY for the Adjunctive Treatment of Surgically Excised Keloids: A Review. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Descriptive study of patients receiving excision and radiotherapy for keloids. [2015]

5. United States pubmed.ncbi.nlm.nih.gov

Optimizing Radiotherapy for Keloids: A Meta-Analysis Systematic Review Comparing Recurrence Rates Between Different Radiation Modalities. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

Radiotherapy in the management of keloids. Clinical experience with electron beam irradiation and comparison with X-ray therapy. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

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

8. United States pubmed.ncbi.nlm.nih.gov

Postoperative carbon ion radiotherapy for keloids: a preliminary report of 16 cases and review of the literature. [2015]

9. United States pubmed.ncbi.nlm.nih.gov

Postoperative management of keloids: low-dose-rate and high-dose-rate brachytherapy. [2022]