Clinical trial · Observational
Phase 2 Total Skin Electron Beam Therapy (TSEBT 12 Gy) in Stage IB-IIIA Mycosis Fungoides
A Phase II Study of Total Skin Electron Beam Therapy (TSEBT) to Dose of 12 Gy in Stage IB-IIIA Mycosis Fungoides
NCT00985140CI-TRIAL-00027964terminatedResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Competing studies
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphomas: Non-Hodgkin | Non-Hodgkin Lymphoma | ALIAS | 0.90 |
| Lymphomas: Non-Hodgkin Cutaneous Lymphoma | — | UNRESOLVED | — |
| Lymphomas: Non-Hodgkin Peripheral T-Cell | — | UNRESOLVED | — |
| Mycosis Fungoides | Mycosis Fungoides | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Total Skin Electron Beam Therapy (TSEBT) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- 12 Gy TSEBT
- description
- Prospective assignment to receive 12 Gy total skin electron beam therapy (TSEBT) for mycosis fungoides
- interventionNames
- Radiation: Total Skin Electron Beam Therapy (TSEBT)
Primary outcomes (1)
- measure
- Clinical Response Rate
- timeFrame
- 1 year
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.