Trial Outcomes & Findings for Study of Total Skin Electron Beam Therapy (TSEBT) in Stage IB-IIIA Mycosis Fungoides (NCT NCT01073267)
NCT ID: NCT01073267
Last Updated: 2015-12-31
Results Overview
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.
COMPLETED
PHASE2
4 participants
Baseline and at least 2 months
2015-12-31
Participant Flow
Recruitment period: February 19, 2010 to April 19, 2011. All participants recruited at The University of Texas MD Anderson Cancer Center.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
4
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Disease Progression
|
3
|
Baseline Characteristics
Study of Total Skin Electron Beam Therapy (TSEBT) in Stage IB-IIIA Mycosis Fungoides
Baseline characteristics by cohort
| Measure |
TSEBT
n=4 Participants
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.
|
|---|---|
|
Age, Continuous
|
69 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Baseline and at least 2 monthsPopulation: Intent to treat population.
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.
Outcome measures
| Measure |
TSEBT
n=4 Participants
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.
|
|---|---|
|
Objective Response Rate
|
.25 proportion of participants
|
Adverse Events
TSEBT
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
TSEBT
n=4 participants at risk
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.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
25.0%
1/4 • Number of events 1 • 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).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
50.0%
2/4 • Number of events 2 • 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).
|
|
General disorders
Fatigue
|
25.0%
1/4 • Number of events 1 • 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).
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin (Other
|
25.0%
1/4 • Number of events 1 • 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).
|
|
General disorders
Pain
|
25.0%
1/4 • Number of events 1 • 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).
|
|
Cardiac disorders
Atrial fibrillation
|
25.0%
1/4 • Number of events 1 • 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).
|
|
Gastrointestinal disorders
Mucositis oral
|
50.0%
2/4 • Number of events 3 • 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).
|
|
Eye disorders
Vision blurred
|
25.0%
1/4 • Number of events 1 • 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).
|
|
Eye disorders
Watering eyes
|
25.0%
1/4 • Number of events 1 • 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).
|
|
Eye disorders
Photophobia
|
25.0%
1/4 • Number of events 1 • 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).
|
|
Eye disorders
Ocular/Visual (Other)
|
25.0%
1/4 • Number of events 1 • 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).
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
25.0%
1/4 • Number of events 1 • 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).
|
|
Skin and subcutaneous tissue disorders
Fat atrophy
|
25.0%
1/4 • Number of events 1 • 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).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
25.0%
1/4 • Number of events 1 • 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).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
25.0%
1/4 • Number of events 1 • 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).
|
Additional Information
Bouthaina Dabaja, MD/Associate Professor, Radiation Oncology Department
University of Texas (UT) MD Anderson Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place