Back to resultsHelical Irradiation of Total Skin (HITS) for Cutaneous Lymphoma (HITS)
Primary Purpose
Cutaneous T-cell Lymphoma
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
HITS
Sponsored by
About this trial
This is an interventional treatment trial for Cutaneous T-cell Lymphoma focused on measuring Cutaneous T-cell lymphoma, Helical irradiation of the total skin, Refractory, Total skin electron beam therapy
Eligibility Criteria
Inclusion Criteria:
- The stage I-IV cutaneous T-cell lymphoma (CTCL) of International Society Cutaneous Lymphomas (ISCL) and U.S. Cutaneous Lymphoma Consortium (USCLC)/European Organization for Research & Treatment of Cancer (EORTC), patients who are candidates for TSEB by recommendation of National Comprehensive Cancer Network Guidelines (Version 4.2011, Mycosis fungoid/Sezary syndrome)
- Patients who are refractory or not feasible to the topic UV irradiation, Interferon alpha, psoralen plus ultraviolet A photochemotherapy, and Isotretinoin or chemotherapy.
- Eligibility criteria included the following: Karnofsky status 70% or greater; creatinine clearance greater than 50 mL/min; cardiac left ventricular ejection fraction 50% or greater; aspartate aminotransferase and alanine aminotransferase less than 2.5 times the upper limits of institutional normal; adequate pulmonary function as shown by a forced expiratory volume of greater than 60%; and peripheral neuropathy grade 1 or lower. Patients were preassessed for their ability to lie supine for approximately 1 hour.
- They had to be previously untreated TSEBT. Prior local radiation was permitted.
- All patients voluntarily signed an informed consent form approved by the Institutional Review Board.
Exclusion Criteria:
- Patient were prior treated by TSEBT for CTCL, another type of cancer, abnormal cardiac function (systolic ejection fraction < 50 percent or an abnormal stress test), chronic respiratory disease (vital capacity or carbon monoxide diffusion, < 50 percent of normal), abnormal liver function (serum bilirubin, > 2.0 mg per deciliter [>35 micromol per liter]; or serum aminotransferase values more than four times the normal value), and psychiatric disease.
- Females who are pregnant/lactating or planning to be pregnant.
- Patients with other systemic diseases that required long-term (≥ 2 weeks) usage of glucocorticosteroid or immunosuppressant agent(s) within 4 weeks prior to the initiation of study treatment.
- Child or handicap are excluded
Sites / Locations
- Far Eastern Memorial Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HITS for CTCL
Arm Description
Cutaneous T-cell lymphoma treats by helical irradiation of the total skin (HITS) using helical tomotherapy
Outcomes
Primary Outcome Measures
Number of Participants with Serious and Non-Serious Adverse Events
participants will be followed from the duration of RT to RT finish 1 month, an expected average of 3 ms
Secondary Outcome Measures
Time to Disease Progression
Full Information
NCT ID
NCT02039895
First Posted
January 15, 2014
Last Updated
August 1, 2014
Sponsor
Far Eastern Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02039895
Brief Title
Helical Irradiation of Total Skin (HITS) for Cutaneous Lymphoma
Acronym
HITS
Official Title
Helical Irradiation of Total Skin (HITS) for Cutaneous Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Far Eastern Memorial Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Radiation therapy, Total skin electron beam therapy (TSEBT), achieves a high response rate and is an effective treatment for cutaneous T-cell lymphoma affecting the superficial region. One the most widely used TSEBT techniques consists of six dual fields initially developed at Stanford University. However, deviations occur from the prescription dose up to 40% and the surface dose inhomogeneity as much as 90% in body areas such as the perineum and eyelid.
Helical tomotherapy (HT) has advantages in irradiating extended volumes with treatment length of up to 160 cm, continuously in a helical pattern without the need for field junction. Using HT, an image-guided intensity-modulated radiotherapy, to replace conventional TSEBT technique to increase dose delivery and decrease toxicities possibly. Recently, we published the possibility of helical irradiation of the total skin (HITS) by physical proving and showed the clinical results of HITS successfully for a woman with T cell lymphoma failure by chemotherapy, topic UV irradiation and local radiotherapy (RT) to overcome the surface dose inhomogeneity by conventional RT.
Here, investigators will enroll the stage I-IV cutaneous T-cell lymphoma (CTCL) of International Society Cutaneous Lymphomas (ISCL)/U.S. Cutaneous Lymphoma Consortium (USCLC)/European Organization for Research & Treatment of Cancer (EORTC), patients who are candidates for TSEBT by recommendation of National Comprehensive Cancer Network Guidelines (Version 4.2011, Mycosis fungoid/Sezary syndrome) or who are refractory or not feasible to the topic UV irradiation, Interferon alpha, psoralen plus ultraviolet A photochemotherapy, and Accutane® (Isotretinoin) or chemotherapy to receive HITS to replace TSEBT. Additionally, we will compare the advantages and disadvantages between the plan of HT and conventional RT for TSEBT.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cutaneous T-cell Lymphoma
Keywords
Cutaneous T-cell lymphoma, Helical irradiation of the total skin, Refractory, Total skin electron beam therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HITS for CTCL
Arm Type
Experimental
Arm Description
Cutaneous T-cell lymphoma treats by helical irradiation of the total skin (HITS) using helical tomotherapy
Intervention Type
Radiation
Intervention Name(s)
HITS
Intervention Description
Helical irradiation of the total skin by helical tomotherapy
Primary Outcome Measure Information:
Title
Number of Participants with Serious and Non-Serious Adverse Events
Description
participants will be followed from the duration of RT to RT finish 1 month, an expected average of 3 ms
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Time to Disease Progression
Time Frame
Up to 24 ms
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The stage I-IV cutaneous T-cell lymphoma (CTCL) of International Society Cutaneous Lymphomas (ISCL) and U.S. Cutaneous Lymphoma Consortium (USCLC)/European Organization for Research & Treatment of Cancer (EORTC), patients who are candidates for TSEB by recommendation of National Comprehensive Cancer Network Guidelines (Version 4.2011, Mycosis fungoid/Sezary syndrome)
Patients who are refractory or not feasible to the topic UV irradiation, Interferon alpha, psoralen plus ultraviolet A photochemotherapy, and Isotretinoin or chemotherapy.
Eligibility criteria included the following: Karnofsky status 70% or greater; creatinine clearance greater than 50 mL/min; cardiac left ventricular ejection fraction 50% or greater; aspartate aminotransferase and alanine aminotransferase less than 2.5 times the upper limits of institutional normal; adequate pulmonary function as shown by a forced expiratory volume of greater than 60%; and peripheral neuropathy grade 1 or lower. Patients were preassessed for their ability to lie supine for approximately 1 hour.
They had to be previously untreated TSEBT. Prior local radiation was permitted.
All patients voluntarily signed an informed consent form approved by the Institutional Review Board.
Exclusion Criteria:
Patient were prior treated by TSEBT for CTCL, another type of cancer, abnormal cardiac function (systolic ejection fraction < 50 percent or an abnormal stress test), chronic respiratory disease (vital capacity or carbon monoxide diffusion, < 50 percent of normal), abnormal liver function (serum bilirubin, > 2.0 mg per deciliter [>35 micromol per liter]; or serum aminotransferase values more than four times the normal value), and psychiatric disease.
Females who are pregnant/lactating or planning to be pregnant.
Patients with other systemic diseases that required long-term (≥ 2 weeks) usage of glucocorticosteroid or immunosuppressant agent(s) within 4 weeks prior to the initiation of study treatment.
Child or handicap are excluded
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chen-Hsi Hsieh, M.D., Ph.D.
Organizational Affiliation
Far Eastern Memorial Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Far Eastern Memorial Hospital
City
New Taipei City
ZIP/Postal Code
220
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
Helical Irradiation of Total Skin (HITS) for Cutaneous Lymphoma
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