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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2011-00560 | Registry Identifier | NCI CTRP |
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The goal of this clinical research study is to learn if a lower than standard dose of total skin electron beam radiation therapy to the skin can help to control mycosis fungoides. The safety of this dose level will also be studied.
Study Radiation:
During total skin electron beam therapy, radiation is given to the entire surface of the skin. This may cause the cancer cells to die.
Researchers would like to learn the level of effectiveness of this lower dose of radiation therapy because it is likely to have fewer side effects than the standard, higher dose.
Screening Period:
Signing this consent form does not mean that you will be able to take part in this study. You will have the following "screening tests" to help the doctor decide if you are eligible to take part in this study.
Within 6 weeks before the radiation therapy can begin:
Within 4 weeks before the radiation therapy can begin:
The study doctor will discuss the screening test results with you. If the screening tests show that you are not eligible to take part in the study, you will not be enrolled. Other treatment options will be discussed with you.
Wash-Out Period:
If you agree to take part in this study, from that day until your first study radiation treatment, you will stop certain treatments for mycosis fungoides. This is called a "wash-out period". The number of weeks will be different depending on what treatments you may be receiving. The study doctor will explain the types of treatments and schedule for stopping them.
Study Visit Before Radiation Therapy:
Within 1 week before your first radiation treatment, the following tests and procedures will be performed:
-You will have a physical exam, including a skin exam and measurement of your weight and vital signs.
Your performance status will be recorded.
Radiation Treatments:
If you are found to be eligible to take part in this study, you will receive low-dose radiation to the skin 4-5 days a week for 3 weeks.
On Mondays and Tuesdays, you will receive radiation that can cover your entire skin area. You will be standing during the treatment. This wider-field radiation treatment cannot give enough radiation to the unexposed areas of your body, such as under the arms, under the breasts for females, under the belly, in the private areas, and the soles of the feet. For this reason, in addition to the wider-field radiation, you will also receive radiation that covers these smaller areas of your body on Wednesdays and Thursdays. The amount of radiation that these smaller body areas will receive is designed to be the same as the amount the rest of the skin will receive.
If the study doctor thinks it is needed for standard care, you will also receive radiation treatments on other tumors. In most cases, this will be on Fridays. It will be 4-7 treatments, depending on the tumor size.
At Weeks 2 and 3 of radiation treatment, you will be asked about any side effects that have occurred.
Length of Study:
You may receive up to 3 weeks of low-dose radiation therapy. You will be taken off the study treatment early if intolerable side effects occur or the disease gets worse. The follow-up period in this study lasts up to 12 months after the last treatment.
Follow-Up and End-of-Study Visits:
After your last dose of low-dose radiation therapy, you will have follow-up visits 1 to 3 weeks after treatment, every 2 months for 6 months, and then every 3 months for a total of 12 months. However, if the disease gets worse during this 12-month follow-up period, the follow-up visits will stop. When you are off-study, an end-of-study visit will occur.
If you stopped the radiation early due to intolerable side effects, you will have follow-up visits twice a week until the doctor thinks the side effects have gotten better. After that, you will return for an end-of-study visit.
At the follow-up visits and end-of-study visit, the following tests and procedures will be performed:
This is an investigational study. For this type of cancer, the dose of radiation in this study is lower than standard. The type of radiation therapy (total skin electron beam therapy) is standard. At this time, the lower dose is only being used in research.
Up to 20 patients will be take part in this study. All will be enrolled at M. D. Anderson.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TSEBT | Experimental | Total Skin Electron Beam Therapy (TSEBT) to dose of 12 Gy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TSEBT | Radiation | Total skin electron beam therapy (TSEBT) to a total dose of 12 Gray (TSEBT 12 Gy), low-dose radiation to the skin 4-5 days a week for 3 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | Objective response rate defined as the proportion of participants achieving complete clinical response (CCR) and partial response (PR) (i.e. overall response (OR)) as assessed by the modified Severity-Weighted Assessment Tool (mSWAT). Clinical response (according to mSWAT) are documented as stable disease (SD), partial response (PR), complete clinical response (CCR), or progressive disease (PD) as defined: Complete clinical response (CCR): no evidence of cutaneous disease on exam, confirmed at 4 week time point; Partial response (PR): ≥ 50% decrease of modified SWAT score compared to baseline score, confirmed at 4 week time point; Stable disease (SD): Neither CR, PR, or PD, i.e. change from baseline is less than 50% decrease, but also less than 25% increase in mSWAT score compared to nadir score; Progressive disease (PD): ≥ 25% increase in modified SWAT score compared with nadir score. | Baseline and at least 2 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bouthaina Dabaja, MD | M.D. Anderson Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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Recruitment period: February 19, 2010 to April 19, 2011. All participants recruited at The University of Texas MD Anderson Cancer Center.
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| ID | Title | Description |
|---|---|---|
| FG000 | TSEBT | Total skin electron beam therapy (TSEBT) to a total dose of 12 Gray (TSEBT 12 Gy), low-dose radiation to the skin 4-5 days a week for 3 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | TSEBT | Total skin electron beam therapy (TSEBT) to a total dose of 12 Gray (TSEBT 12 Gy), low-dose radiation to the skin 4-5 days a week for 3 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Objective Response Rate | Objective response rate defined as the proportion of participants achieving complete clinical response (CCR) and partial response (PR) (i.e. overall response (OR)) as assessed by the modified Severity-Weighted Assessment Tool (mSWAT). Clinical response (according to mSWAT) are documented as stable disease (SD), partial response (PR), complete clinical response (CCR), or progressive disease (PD) as defined: Complete clinical response (CCR): no evidence of cutaneous disease on exam, confirmed at 4 week time point; Partial response (PR): ≥ 50% decrease of modified SWAT score compared to baseline score, confirmed at 4 week time point; Stable disease (SD): Neither CR, PR, or PD, i.e. change from baseline is less than 50% decrease, but also less than 25% increase in mSWAT score compared to nadir score; Progressive disease (PD): ≥ 25% increase in modified SWAT score compared with nadir score. | Intent to treat population. | Posted | Number | proportion of participants | Baseline and at least 2 months |
|
Adverse event information collected during the 3-week treatment period and for 3 months following completion of TSEBT (this applies to participants who withdraw from the study).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TSEBT | Total skin electron beam therapy (TSEBT) to a total dose of 12 Gray (TSEBT 12 Gy), low-dose radiation to the skin 4-5 days a week for 3 weeks. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Erythema multiforme | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bouthaina Dabaja, MD/Associate Professor, Radiation Oncology Department | University of Texas (UT) MD Anderson Cancer Center | CR_Study_Registration@mdanderson.org |
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| ID | Term |
|---|---|
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| TSEBT |
Total skin electron beam therapy (TSEBT) to a total dose of 12 Gray (TSEBT 12 Gy), low-dose radiation to the skin 4-5 days a week for 3 weeks. |
|
|
| 0 |
| 4 |
| 3 |
| 4 |
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dermatology/Skin (Other | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| Mucositis oral | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Vision blurred | Eye disorders | CTCAE (3.0) | Systematic Assessment |
|
| Watering eyes | Eye disorders | CTCAE (3.0) | Systematic Assessment |
|
| Photophobia | Eye disorders | CTCAE (3.0) | Systematic Assessment |
|
| Ocular/Visual (Other) | Eye disorders | CTCAE (3.0) | Systematic Assessment |
|
| Rash desquamating | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Fat atrophy | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
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| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |