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Radiation

Radiation Therapy for Dupuytren's Contracture

N/A
Recruiting
Led By Lance Warhold, MD
Research Sponsored by Dartmouth-Hitchcock Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 45 or greater with DC
Extension deficit >10 degrees
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one month, 6 months, 12 months, 24 months, and 36 months post-radiation treatment
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to see if targeted radiation therapy can help prevent Dupuytren's Contracture from coming back after treatment with Collagenase Clostridium Histolyticum. Participants will receive

Who is the study for?
This trial is for individuals over 45 with Dupuytren's Contracture (DC) who can't lay their finger and palm flat on a table due to the condition. It's open to those who've had non-surgical release using Collagenase Clostridium Histolyticum, but only for the first two joints treated. Post-menopausal women or those using contraception can join.
What is being tested?
The study tests if targeted radiation therapy can prevent Dupuytren's contracture from coming back after treatment with an enzyme injection. Participants will receive daily radiation treatments for five days, rest for 6-8 weeks, then have another five-day course of radiation.
What are the potential side effects?
Radiation therapy may cause skin redness, soreness, swelling at the treatment site, fatigue during the course of treatment and possibly some long-term changes in skin texture or color.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 45 years old or older with ductal carcinoma.
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I cannot fully straighten my arm or leg.
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I can't lay my hand flat due to my finger condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one month, 6 months, 12 months, 24 months, and 36 months post-radiation treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and one month, 6 months, 12 months, 24 months, and 36 months post-radiation treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Recurrence of Dupuytren's Contracture
Secondary study objectives
Patient Reported Outcomes after Radiation Treatment (RT)
Radiation Toxicity

Side effects data

From 2013 Phase 3 trial • 397 Patients • NCT00004054
78%
Menopausal symptoms
60%
Urinary frequency
52%
Impotence
47%
Late RT Toxicity: Bladder: NOS
39%
Diarrhea NOS
27%
Late RT Toxicity: Bowel: NOS
26%
Fatigue
26%
Late RT Toxicity: Other GU: NOS
21%
Proctitis NOS
21%
Dysuria
14%
Libido decreased
14%
Dermatitis radiation NOS
12%
Late RT Toxicity: Other: NOS
12%
Late RT Toxicity: Other GI: NOS
12%
Hemoglobin decreased
12%
Alanine aminotransferase increased
9%
Gynaecomastia
8%
Urinary retention
7%
Pain-other
7%
Aspartate aminotransferase increased
6%
Rectal bleeding
6%
Constipation
6%
Leukopenia NOS
4%
Edema NOS
4%
Hematuria present
4%
Renal/GU-Other
3%
Arthralgia
3%
Blood creatinine increased
3%
Dyspnea NOS
3%
Dermatitis exfoliative NOS
2%
Depression NEC
2%
Nausea
2%
Hyperglycemia NOS
2%
Lymphopenia
2%
Myalgia
2%
Peripheral sensory neuropathy
1%
Platelet count decreased
1%
Hyponatremia
1%
Hypocalcemia
1%
Blood albumin decreased
1%
Stomatitis
1%
Weight decreased
1%
Anorexia
1%
Hematologic-Other
1%
Neutropenia
1%
Alopecia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Hormones and RT
Hormones and RT Plus Chemotherapy

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: Patients with Dupuytren's ContactureExperimental Treatment1 Intervention
Patients with Dupuytren's Contacture will undergo Collagenase Clostridium Histolyticum injection and release followed by two 5-day courses of radiation therapy separated by 6-8 weeks. They will then be followed for 3 years for recurrence.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiation therapy
2013
Completed Phase 3
~2850

Find a Location

Who is running the clinical trial?

Dartmouth-Hitchcock Medical CenterLead Sponsor
537 Previous Clinical Trials
2,539,657 Total Patients Enrolled
Lance Warhold, MDPrincipal InvestigatorDartmouth Health
~63 spots leftby Apr 2029
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