Clinical trial NCT03040804: Low Dose Radiotherapy for Advanced Hidradenitis Suppurativa
Official title: A Phase I Study of Low Dose Radiotherapy for Advanced Hidradenitis Suppurativa
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hidradenitis Suppurativa
Hidradenitis
Keywords: hidradenitis suppurativa
HS
radiotherapy
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2017-02-02
Enrollment: 2
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Simon two-stage design. In the first stage, 6 patients will be enrolled. If the patients in the study do not meet the termination criteria then the study will extend to a second stage and a maximum of 20 patients will be enrolled.
Primary purpose: TREATMENT

Brief summary: To establish the safety of radiotherapy in the treatment of advanced hidradenitis suppurativa. Patients will receive radiotherapy treatment over one week and then they will be followed for the next three months.

Detailed description: This is a phase I clinical trial using a Simon-two stage design to establish the safety of radiotherapy in the treatment of advanced hidradenitis suppurativa (HS). In the first six months, 6 patients will be enrolled, if the patients in the study do not meet the termination criteria, then the study will extend to a second stage. A maximum of 20 patients will be enrolled. Patients will be treated with skin-directed radiotherapy, using a total prescription dose of 7.5 Gy in five fractions of 1.5 Gy over one week. Patients will then be seen in the HS specialty clinic at Montefiore Medial Center for at least three months. Quality of life changes, immunohistochemical changes, and cutaneous discharge will also be evaluated during the study period.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Hidradenitis Suppurativa made at the Montefiore Hidradenitis Suppurativa Treatment Center, with Hurley Stage 2-3 (defined as recurrent abscesses or boils with diffuse or broad involvement, multiple interconnected sinus tracts in the whole area)
* Failed maximal medical therapy for Hidradenitis Suppurativa or ineligible for "standard" medical therapy or surgery
* Age \> 20 years
* Women of childbearing age: must have a negative pregnancy test within 72 hours prior to the start of study therapy and agree to an adequate method of contraception throughout treatment and for at least 4 weeks after study contraception.

Exclusion Criteria:

* Pregnant women
* Individuals \< 20 years old

Primary outcomes:
measure: Number of Participants With HS Who Experience Treatment-related Grade ≥3 Adverse Events During Radiotherapy or Within 3 Months of Radiotherapy Completion, Assessed Using CTCAE Version 4.0
timeFrame: follow up for 3-6 months post treatment
Secondary outcomes:
measure: Changes in NIH Patient-Reported Outcomes Measurement Information System (PROMIS).
timeFrame: 6 months - 1 year post treatment
measure: Evaluation of Radiotherapy Associated Hidradenitis Suppurativa Lesions.
timeFrame: 3-6 months post treatment
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Steven R Cohen, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: