NCT03507010

Brief Summary

The aim of the LedRad trial is to determine the efficacy and durability of radiotherapy as treatment for patients with Ledderhose disease and to compare this to the natural course of Ledderhose disease.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at below P25 for phase_3

Timeline
35mo left

Started Jan 2018

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress74%
Jan 2018Mar 2029

Study Start

First participant enrolled

January 23, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 27, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 24, 2018

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2021

Completed
7.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2029

Expected
Last Updated

February 28, 2024

Status Verified

February 1, 2024

Enrollment Period

3.6 years

First QC Date

February 27, 2018

Last Update Submit

February 26, 2024

Conditions

Ledderhose Disease

Keywords

RadiotherapyPain

Outcome Measures

Primary Outcomes (1)

  • Numeric Rating Scale

    Determine pain with the Numeric Rating Scale

    12 months

Secondary Outcomes (9)

  • Numeric Rating Scale

    6 and 18 months

  • Size of ledderhose nodules

    12 months

  • Walking distance

    6, 12 and 18 months

  • Walking motion

    12 months

  • Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    18 months

  • +4 more secondary outcomes

Study Arms (2)

Radiotherapy

EXPERIMENTAL

Patients assigned to the Radiotherapy group are treated with electrons and will receive a total dose of 30 Gy.

Radiation: Radiotherapy

Sham Radiotherapy

PLACEBO COMPARATOR

Patients assigned to the sham-radiotherapy group will not actually receive radiation. For these patients the radiation is simulated.

Other: Sham Radiotherapy

Interventions

RadiotherapyRADIATION

Patients randomized to the Radiotherapy arm will be treated with electrons and receive a total dose of 30 Gy (two separate courses of five daily fractions of 3.0 Gy each).

Radiotherapy
Sham RadiotherapyOTHER

Patients randomized to the sham-radiotherapy will not be treated and the radiotherapy treatment will only be simulated.

Sham Radiotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with painful Ledderhose disease. The pain score measured with the VAS score and is at least 2 on the 11-point scale (0 = no pain to 10 = worst imaginable pain).
  • Age ≥ 18 years
  • WHO performance status 0, 1 or 2 (Appendix, section 18)
  • Before patient randomisation, written informed consent must be given according to ICH/GCP, and WMO requirements.
  • Controlling the Dutch language (speaking and reading).
  • Able and willing to complete quality of life questionnaires in Dutch
  • Must be accessible for treatment follow-up

You may not qualify if:

  • Surgical intervention before for Ledderhose disease
  • Previous radiation treatment for Ledderhose disease
  • Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
  • Not able to lay prone for at least fifteen minutes
  • Females who are pregnant at entry or who want to become pregnant within six months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Groningen

Groningen, 9700RB, Netherlands

Location

MeSH Terms

Conditions

Fibromatosis, PlantarPain

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

FibromaNeoplasms, Fibrous TissueNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsFoot DiseasesMusculoskeletal DiseasesContractureMuscular DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesSkin DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2018

First Posted

April 24, 2018

Study Start

January 23, 2018

Primary Completion

August 15, 2021

Study Completion (Estimated)

March 15, 2029

Last Updated

February 28, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)