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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

Must not have

Prior RT to the area of interest that would result in overlap of radiation therapy fields

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year post radiotherapy

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I've had radiation therapy before in the same area where it's planned now.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year post radiotherapy

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Treatment-related toxicities

Secondary study objectives

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

Rigors/chills

Dizziness/lightheadedness

Injection site reaction

Dysphagia-esophageal radiation

Hypoglycemia

Blood bilirubin increased

Chest pain

Pain-other

Phlebitis

Creatinine increased

Edema

Pruritus

Hot flashes

Infection w/ grade 3 or 4 neutropenia

Weight loss

Muscle weakness

Depression

Mouth dryness

Transfusion: pRBCs

Pneumonitis/pulmonary infiltrates

Thrombosis/embolism

Febrile neutropenia

Irregular menses

Nail changes

Allergic rhinitis

Allergic reaction

Infection w/ unknown ANC

Syncope

Sinus tachycardia

Dehydration

Neuropathic pain

100%

80%

60%

40%

20%

Study treatment Arm

Arm B (Stanford V)

Arm A (ABVD)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 2Eligibility criteria met