Trial Outcomes & Findings for Phase 2 Total Skin Electron Beam Therapy (TSEBT 12 Gy) in Stage IB-IIIA Mycosis Fungoides (NCT NCT00985140)
NCT ID: NCT00985140
Last Updated: 2017-06-02
Results Overview
After the completion of TSEBT, patients will be followed every 4 weeks until 24 weeks ,and then every 8 weeks for a total of 12 months or until there is disease progression, relapse, or the initiation of a new anti-cancer therapy. The primary endpoint for the trial was the clinical response rate as defined by the modified severity weighted assessment tool (mSWAT) Partial response was defined as 50% improvement in the mSWAT. Complete response was complete disappearance of disease.
TERMINATED
13 participants
1 year
2017-06-02
Participant Flow
Patients who may be eligible for the trial will be approached by the Investigator and offered participation in the trial. During a clinic visit, the Investigator or co-Investigator will explain the study to the potential subject verbally, and will allow the potential subject ample opportunity to ask questions.
Patients will undergo the following procedures during the screening period: Medical Hx, H\&P, Severity Weighted Assessment Tool (mSWAT) assessment, simulation/set-up for TSEBT, CT if needed, pruritus, hair, and nail assessment, standardized photos (global, nails, head: top, front, sides, back), and two 5 mm punch biopsies from an active MF lesion.
Participant milestones
| Measure |
12 Gy TSEBT
Total skin electron beam therapy will be administered in the Department of Radiation Oncology according to the Stanford six-field technique. Patients will receive a planned total skin dose of 12 Gy fractionated at 2 Gy/cycle (each cycle requiring 2 days of treatment) 4 days each week, for 3 weeks. Discrete tumors may receive additional "boost" treatment not to exceed 12 Gy. .
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase 2 Total Skin Electron Beam Therapy (TSEBT 12 Gy) in Stage IB-IIIA Mycosis Fungoides
Baseline characteristics by cohort
| Measure |
12 Gy TSEBT
n=15 Participants
Total skin electron beam therapy will be administered in the Department of Radiation Oncology according to the Stanford six-field technique. Patients will receive a planned total skin dose of 12 Gy fractionated at 2 Gy/cycle (each cycle requiring 2 days of treatment) 4 days each week, for 3 weeks. Discrete tumors may receive additional "boost" treatment not to exceed 12 Gy.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
|
Age, Continuous
|
61.4 years
STANDARD_DEVIATION 15.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: All patients who completed treatment.
After the completion of TSEBT, patients will be followed every 4 weeks until 24 weeks ,and then every 8 weeks for a total of 12 months or until there is disease progression, relapse, or the initiation of a new anti-cancer therapy. The primary endpoint for the trial was the clinical response rate as defined by the modified severity weighted assessment tool (mSWAT) Partial response was defined as 50% improvement in the mSWAT. Complete response was complete disappearance of disease.
Outcome measures
| Measure |
12 Gy TSEBT
n=13 Participants
Total skin electron beam therapy will be administered in the Department of Radiation Oncology according to the Stanford six-field technique. Patients will receive a planned total skin dose of 12 Gy fractionated at 2 Gy/cycle (each cycle requiring 2 days of treatment) 4 days each week, for 3 weeks. Discrete tumors may receive additional "boost" treatment not to exceed 12 Gy. .
|
|---|---|
|
Clinical Response Rate
Partial Response
|
11 participants
|
|
Clinical Response Rate
Stable disease
|
2 participants
|
Adverse Events
12 Gy TSEBT
Serious adverse events
| Measure |
12 Gy TSEBT
n=13 participants at risk
Total skin electron beam therapy will be administered in the Department of Radiation Oncology according to the Stanford six-field technique. Patients will receive a planned total skin dose of 12 Gy fractionated at 2 Gy/cycle (each cycle requiring 2 days of treatment) 4 days each week, for 3 weeks. Discrete tumors may receive additional "boost" treatment not to exceed 12 Gy. .
|
|---|---|
|
Nervous system disorders
Syncope
|
7.7%
1/13 • Number of events 1 • Adverse event data was collected for 1 year.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin Other
|
7.7%
1/13 • Number of events 1 • Adverse event data was collected for 1 year.
|
Other adverse events
| Measure |
12 Gy TSEBT
n=13 participants at risk
Total skin electron beam therapy will be administered in the Department of Radiation Oncology according to the Stanford six-field technique. Patients will receive a planned total skin dose of 12 Gy fractionated at 2 Gy/cycle (each cycle requiring 2 days of treatment) 4 days each week, for 3 weeks. Discrete tumors may receive additional "boost" treatment not to exceed 12 Gy. .
|
|---|---|
|
Skin and subcutaneous tissue disorders
Erythema
|
38.5%
5/13 • Number of events 5 • Adverse event data was collected for 1 year.
|
|
General disorders
Fatigue
|
53.8%
7/13 • Number of events 7 • Adverse event data was collected for 1 year.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
92.3%
12/13 • Number of events 12 • Adverse event data was collected for 1 year.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
7.7%
1/13 • Number of events 1 • Adverse event data was collected for 1 year.
|
|
Skin and subcutaneous tissue disorders
Nail Changes
|
46.2%
6/13 • Number of events 6 • Adverse event data was collected for 1 year.
|
|
Skin and subcutaneous tissue disorders
Skin Infection
|
23.1%
3/13 • Number of events 3 • Adverse event data was collected for 1 year.
|
|
Skin and subcutaneous tissue disorders
desquamation
|
15.4%
2/13 • Number of events 2 • Adverse event data was collected for 1 year.
|
|
General disorders
edema, nos
|
7.7%
1/13 • Number of events 1 • Adverse event data was collected for 1 year.
|
|
Gastrointestinal disorders
Pain (extremity)
|
46.2%
6/13 • Number of events 6 • Adverse event data was collected for 1 year.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders-other
|
15.4%
2/13 • Number of events 2 • Adverse event data was collected for 1 year.
|
Additional Information
Richard T. Hoppe, MD Henry S. Kaplan Harry Lebeson Professor of Cancer Biology
Stanford University Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place