Radiation Therapy for Dupuytren's Contracture
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Dartmouth-Hitchcock Medical Center
Disqualifiers: Pregnancy, Neuromuscular disorders, others
No Placebo Group
Approved in 6 Jurisdictions
Trial Summary
What is the purpose of this trial?The goal of this study is to learn about preventing recurrence of Dupuytren's Contracture. The main question it aims to answer are:
• Does targeted radiation therapy decrease recurrence of Dupuytren's contracture after treatment with Collagenase Clostridium Histolyticum?
Participants will undergo:
* Release of Dupuytren's Contracture after Collagenase Clostridium Histolyticum injection
* Daily radiation therapy treatment for 5 days followed by 6-8 week rest period and then another course of 5 days of radiation therapy
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of this treatment for Dupuytren's Contracture?
Research on intraoperative radiotherapy (IORT) shows it can effectively deliver high doses of radiation directly to the tumor bed, reducing recurrence in breast cancer patients. While this is not directly related to Dupuytren's Contracture, it suggests that targeted radiation can be effective in treating localized conditions.
12345Is radiation therapy generally safe for humans?
Radiation therapy techniques like intensity-modulated radiotherapy (IMRT) and image-guided radiotherapy (IGRT) have been used in various treatments, showing some risks of side effects such as gastrointestinal and genitourinary issues, but these are generally low. Advances in technology have improved safety, making these techniques common in clinical practice.
678910How does radiation therapy differ from other treatments for Dupuytren's contracture?
Radiation therapy is unique for Dupuytren's contracture as it aims to prevent the progression of the disease in its early stages, unlike other treatments that may focus on surgical intervention after significant contracture has developed. It involves using targeted radiation to stop the disease from worsening, which is not a standard approach for this condition.
1112131415Eligibility Criteria
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.Inclusion Criteria
Only my first two joints treated with CCH injections will be considered.
I am 45 years old or older with ductal carcinoma.
I cannot fully straighten my arm or leg.
+2 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo Collagenase Clostridium Histolyticum injection and release followed by two 5-day courses of radiation therapy separated by a 6-8 week rest period
12-14 weeks
Follow-up
Participants are monitored for recurrence of Dupuytren's Contracture and radiation toxicity
36 months
Visits at 1 month, 6 months, 12 months, 24 months, and 36 months post-radiation treatment
Participant Groups
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.
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.
Radiation Therapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
🇪🇺 Approved in European Union as Radiation Therapy for:
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
🇺🇸 Approved in United States as Radiation Therapy for:
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
🇨🇦 Approved in Canada as Radiation Therapy for:
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
🇯🇵 Approved in Japan as Radiation Therapy for:
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
🇨🇳 Approved in China as Radiation Therapy for:
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
🇨🇭 Approved in Switzerland as Radiation Therapy for:
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Dartmouth HitchcockLebanon, NH
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Who Is Running the Clinical Trial?
Dartmouth-Hitchcock Medical CenterLead Sponsor
References
Recurrence and Survival Rates for 1400 Early Breast Tumors Treated with Intraoperative Radiation Therapy (IORT). [2022]Intraoperative radiotherapy (IORT) permits accurate delivery of radiation therapy directly to the tumor bed. We report local, regional, and distant recurrence data along with overall and breast cancer-specific survival for 1400 tumors treated with x-ray IORT.
Intraoperative electron beam radiotherapy (ELIOT) to the breast: a need for a quality assurance programme. [2006]Intraoperative radiotherapy (IORT) is a technique in which a high, single-fraction radiation dose is delivered directly to the tumour bed during a surgical intervention, after the removal of a neoplastic mass. IORT has been recently used in early stage cancer as an exclusive radiation modality, rather than as a boost, especially for breast tumours, in particular at the European Institute of Oncology in Milan, where the technique has been called electron intraoperative therapy (ELIOT). Our studies on more than 1000 patients have demonstrated the feasibility of the technique and it is expected that its application will become more widespread in the immediate future. It is important to emphasise that ELIOT relies not only on new technological developments, but also on a multidisciplinary team with clear roles and responsibilities, the establishment of a programme of quality assurance with appropriate guidelines and a comprehensive staff development programme.
Radiation-related quality of life parameters after targeted intraoperative radiotherapy versus whole breast radiotherapy in patients with breast cancer: results from the randomized phase III trial TARGIT-A. [2021]Intraoperative radiotherapy (IORT) is a new treatment approach for early stage breast cancer. This study reports on the effects of IORT on radiation-related quality of life (QoL) parameters.
Intraoperative high-dose-rate brachytherapy using dose painting technique: evaluation of safety and preliminary clinical outcomes. [2018]Intraoperative radiation therapy (IORT) allows delivery of tumoricidal doses of radiation to areas of potential residual microscopic disease while minimizing doses to normal tissues. IORT using high-dose-rate (HDR) brachytherapy allows dose modulation and delivery of concomitant boosts to high-risk areas. This study describes a novel technique of HDR-IORT with dose painting (DP) (HDR-IORT-DP) and evaluates the clinical outcomes.
Evolution of radiotherapy techniques in breast conservation treatment. [2020]Radiation therapy (RT) is an important component of breast cancer treatment that reduces local recurrence and improves survival after breast conservation. Breast conservation rates have increased significantly since the late 1980s and techniques have improved with greater awareness of the impact of radiation on the heart. An overview of randomized controlled trials of breast conservation using standard whole breast irradiation, whole breast hypofractionation, accelerated partial breast irradiation (APBI) and intraoperative radiation are reviewed. Selection criteria for breast conservation and the utility of adding a boost dose to the primary tumor site are reviewed. Modern dose constraints are documented and 10 different radiation techniques from the 1980s through to modern volumetric modulated arc therapy (VMAT) are compared for a patient where the breast and internal mammary nodes are treated. A radiation boost reduces the risk of a recurrence for most, but not all patients. Short courses of RT over 3-4 weeks are generally as effective as longer courses. Short-term follow-up of trials of APBI show promise for selected good prognosis subgroups. The role of intraoperative radiation remains controversial. In the last 30 years, there have been significant advances in radiation techniques. Modern radiotherapy equipment and techniques will reduce complications and improve survival rates.
Decreased acute toxicities of intensity-modulated radiation therapy for localized prostate cancer with prostate-based versus bone-based image guidance. [2018]Intensity-modulated radiation therapy (IMRT) is a major therapeutic option for localized prostate cancer. Image-guided radiation therapy (IGRT) allows tumor visualization and corrects the errors caused by daily internal movement of the prostate. The current study retrospectively compared the acute toxicities and biochemical tumor control outcomes of prostate IMRT achieved using two IGRT techniques: bony structure-based IGRT (B-IGRT) and prostate-based IGRT (P-IGRT).
Impact of advanced radiotherapy techniques and dose intensification on toxicity of salvage radiotherapy after radical prostatectomy. [2021]The safety and efficacy of dose-escalated radiotherapy with intensity-modulated radiotherapy (IMRT) and image-guided radiotherapy (IGRT) remain unclear in salvage radiotherapy (SRT) after radical prostatectomy. We examined the impact of these advanced radiotherapy techniques and dose intensification on the toxicity of SRT. This multi-institutional retrospective study included 421 patients who underwent SRT at the median dose of 66 Gy in 2-Gy fractions. IMRT and IGRT were used for 225 (53%) and 321 (76%) patients, respectively. At the median follow-up of 50 months, the cumulative incidence of late grade 2 or higher gastrointestinal (GI) and genitourinary (GU) toxicities was 4.8% and 24%, respectively. Multivariate analysis revealed that the non-use of either IMRT or IGRT, or both (hazard ratio [HR] 3.1, 95% confidence interval [CI] 1.8-5.4, p
Quality and Safety Considerations in Image Guided Radiation Therapy: An ASTRO Safety White Paper Update. [2023]This updated report on image guided radiation therapy (IGRT) is part of a series of consensus-based white papers previously published by the American Society for Radiation Oncology addressing patient safety. Since the first white papers were published, IGRT technology and procedures have progressed significantly such that these procedures are now more commonly used. The use of IGRT has now extended beyond high-precision treatments, such as stereotactic radiosurgery and stereotactic body radiation therapy, and into routine clinical practice for many treatment techniques and anatomic sites. Therefore, quality and patient safety considerations for these techniques remain an important area of focus.
Monte Carlo-based software for 3D personalized dose calculations in image-guided radiotherapy. [2022]Image-guided radiotherapy (IGRT) involves frequent in-room imaging sessions contributing to additional patient irradiation. The present work provided patient-specific dosimetric data related to different imaging protocols and anatomical sites.
Dosimetric implications of inter- and intrafractional prostate positioning errors during tomotherapy : Comparison of gold marker-based registrations with native MVCT. [2022]For high-dose radiation therapy (RT) of prostate cancer, image-guided (IGRT) and intensity-modulated RT (IMRT) approaches are standard. Less is known regarding comparisons of different IGRT techniques and the resulting residual errors, as well as regarding their influences on dose distributions.
[Optimization of radiotherapy in Dupuytren's disease. Initial results of a controlled trial]. [2019]Radiotherapy prevents progression of Dupuytren's contracture. Herein, 1-year results of a prospective randomized trial comparing 2 different dose concepts are presented.
Radiotherapy for prevention of disease progression in early-stage Dupuytren's contracture: initial and long-term results. [2019]Radiotherapy (RT) was given to prevent disease progression in early-stage Dupuytren's contracture. Initial response, long-term outcome, and treatment toxicity were evaluated.
Radiotherapy optimization in early-stage Dupuytren's contracture: first results of a randomized clinical study. [2019]Radiotherapy (RT) can prevent progression of Dupuytren's contracture (DC). It is unknown whether there is a dose response and which dose is sufficient. Herein, the 1-year results of a prospective randomized trial are presented which compared two different RT dose concepts with each other.
[Radiotherapy in the early stage of Dupuytren's disease. The indications, technic and long-term results]. [2019]Radiotherapy was applied in our clinic to prevent the disease progression in early stage Dupuytren's contracture. Initial response, long-term outcome, acute and late toxicity of the treatment were evaluated in a retrospective analysis.
[Dupuytren's contracture. Radiotherapy in the early stages]. [2009]Conventional radiotherapy is the treatment of choice for the early stages of the Dupuytren contracture. The conventional semi-deep therapy is more favorable than the soft ray technique and the moulage technique. 62 patients have been treated at Erlangen; 33 out of them (46 irradiated hands) with a minimum observation time of 18 months have been evaluated. The pathologic process was stopped in 98% of the cases. 85% of the patients showed an improvement of troubles by regression of tubercules and cords, pains and sensation of pressure. A recurrence was observed only in one patient at the edge of the irradiated volume.