TriangleNCT00985140 · REGISTRY CONDITION SEARCH
Phase 2 Total Skin Electron Beam Therapy (TSEBT 12 Gy) in Stage IB-IIIA Mycosis Fungoides
Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.
- Phase
- Not reported
- Status at capture
- TERMINATED
- Registry last update
- 2017-06-02
To examine the efficacy and safety of total skin electron beam therapy to a dose of 12 Gray (TSEBT 12 Gy) in patients who have mycosis fungoides (MF) staged as IB to IIIA.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Who could take part
- eligibility Criteria
- Inclusion Criteria:1. Biopsy-confirmed mycosis fungoides in stage IB-IIIA 2\. Patients must have failed or have been intolerant to at least one prior systemic or topical therapy which may include topical steroids 3\. 18 years of age or older 4\. Life expectancy greater than 6 months 5\. Eastern Cooperative Oncology Group (ECOG) of \<= 2 6\. Adequate bone marrow function: WBC\> 2000/uL; platelet count\> 75,000/mm3; ANC\> 1000 7\. Required wash out period for prior therapies (Note: patients with progressive disease may be treated earlier than required washout period per Investigator's decision) * Topical therapy: 2 weeks * Systemic biologic, monoclonal antibody or chemotherapy: 4 weeks * Radiotherapy (excluding TSEBT) or phototherapy: 4 weeks * Other investigational therapy: 4 weeks 8\. Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria:1. Prior courses of TSEBT (Note: localized skin-directed radiotherapy is allowed if administered at least 4 weeks prior to initiation on study) 2\. Underlying medical condition including unstable cardiac disease, or other serious illness that would impair the ability of patient to undergo treatment 3\. Prior malignancy (active within 5 years of screening) except completely excised non-invasive basal cell or squamous cell carcinoma of the skin, or in situ squamous cell carcinoma of the cervix 4\. Pregnant or lactating 5\. Initiation or change in dosage of topical corticosteroids within 3 weeks of study treatment (Note: topical steroid use within 3 weeks is allowed provided the strength and use has been stable for at least 1 month; "prescription strength"topical corticosteroids cannot be started during the study) 6\. Any other medical history, including laboratory results, deemed by the Investigator to be likely to interfere with patient participation in the study
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sampling Method
- NON_PROBABILITY_SAMPLE
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
- study Population
- Subjects with mycosis fungoides refractory to at lest one prior treatment.
Treatment arms and interventions
- arm Groups
- description
- Prospective assignment to receive 12 Gy total skin electron beam therapy (TSEBT) for mycosis fungoides
- intervention Names
- Radiation: Total Skin Electron Beam Therapy (TSEBT)
- label
- 12 Gy TSEBT
- interventions
- arm Group Labels
- 12 Gy TSEBT
- description
- The purpose of the study is to examine the efficacy and safety of total skin electron beam therapy to a dose of 12 Gray (TSEBT 12 Gray) in patients who have mycosis fungoides (MF) staged as IB to IIIB.
- name
- Total Skin Electron Beam Therapy (TSEBT)
- type
- RADIATION
Study design
- observational Model
- COHORT
- time Perspective
- PROSPECTIVE
Enrollment
- count
- 13
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- 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.
- measure
- Clinical Response Rate
- time Frame
- 1 year
Full study description
- brief Summary
- To examine the efficacy and safety of total skin electron beam therapy to a dose of 12 Gray (TSEBT 12 Gy) in patients who have mycosis fungoides (MF) staged as IB to IIIA.
- detailed Description
- 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. Supplements will routinely be applied to the perineum and soles as well as any other "shadowed" sites involved by disease, such as the inframammary regions (1-2 Gy fractions to a total dose of 12 Gy). Discrete tumors may receive additional "boost" treatment not to exceed 12 Gy. During the course of TSEBT patients will be evaluated weekly in the Department of Radiation Oncology for determination of adverse events and toxicity grading according the NCI Common Toxicity Criteria (CTC) Version 3.0. A baseline evaluation will occur on the first day of TSEBT at which time the following procedures will be performed: (This visit may be waived if TSEBT is initiated within one week of the screening visit AND there is no clinical evidence of disease progression). 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. Patients who withdraw during the treatment period due to intolerance to radiotherapy will be followed weekly until toxicities have reverted to Grade ≤ 2 or has stabilized in the opinion of the Investigator, at which point a final visit will be scheduled. A final visit should be attempted for all patients who are lost to follow-up.
Source references
- avail Ipds
- comment
- This publication contains data from this study as well as two other clinical trials. Analysis was done on data pooled from the three trials.
- type
- Peer reviewed article with pooled results.
Source notices and limitations
Discovery and provenance
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Preserved source evidence · Not medical advice