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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ one month, 6 months, 12 months, 24 months, and 36 months post-radiation treatment

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

Gynaecomastia

Urinary retention

Pain-other

Aspartate aminotransferase increased

Rectal bleeding

Constipation

Leukopenia NOS

Edema NOS

Hematuria present

Renal/GU-Other

Arthralgia

Blood creatinine increased

Dyspnea NOS

Dermatitis exfoliative NOS

Depression NEC

Nausea

Hyperglycemia NOS

Lymphopenia

Myalgia

Peripheral sensory neuropathy

Platelet count decreased

Hypocalcemia

Hyponatremia

Blood albumin decreased

Stomatitis

Weight decreased

Anorexia

Hematologic-Other

Neutropenia

Alopecia

100%

80%

60%

40%

20%

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

0 / 3Eligibility criteria met