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This document outlines a clinical trial protocol evaluating the efficacy and safety of Total Skin Electron Beam Therapy (TSEBT) at a total dose of 12 Gy for patients with stage IB-IIIA mycosis fungoides.
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How to fill out A Phase II Study of Total Skin Electron Beam Therapy (TSEBT) to dose of 12 Gy in stage IB-IIIA mycosis fungoides

01
Obtain informed consent from the patient after explaining the study details.
02
Confirm the patient's diagnosis of stage IB-IIIA mycosis fungoides.
03
Conduct a thorough medical evaluation to determine eligibility.
04
Randomly assign the patient to the treatment group for TSEBT at a dose of 12 Gy.
05
Schedule the patient for imaging and baseline assessments.
06
Begin treatment with the total skin electron beam therapy, ensuring the dosage is accurately delivered.
07
Monitor the patient regularly for treatment effects and side effects.
08
Document all patient responses and any adverse reactions during the study.
09
Follow-up with the patient post-treatment for additional assessments and to collect long-term data.

Who needs A Phase II Study of Total Skin Electron Beam Therapy (TSEBT) to dose of 12 Gy in stage IB-IIIA mycosis fungoides?

01
Patients diagnosed with stage IB-IIIA mycosis fungoides who require treatment options.
02
Individuals seeking clinical trial participation for innovative therapies in skin lymphomas.
03
Doctors and clinicians looking for evidence-based options for managing mycosis fungoides.
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A Phase II Study of Total Skin Electron Beam Therapy (TSEBT) to dose of 12 Gy in stage IB-IIIA mycosis fungoides is a clinical research trial that investigates the effectiveness and safety of delivering a total dose of 12 Gy of electron beam radiation to the skin in patients diagnosed with stage IB-IIIA mycosis fungoides, which is a form of cutaneous T-cell lymphoma.
Principal investigators, usually oncologists or researchers leading the study, are required to file the study protocol and related documents with regulatory authorities, including ethical review boards and clinical trial registries.
To fill out the study documentation, researchers should provide detailed information about the study design, patient eligibility criteria, treatment protocols, assessment methods, data collection strategies, and analysis plans, ensuring compliance with ethical and regulatory guidelines.
The purpose of the study is to assess the efficacy, safety, and tolerability of a 12 Gy dose of TSEBT in treating patients with stage IB-IIIA mycosis fungoides, aiming to improve patient outcomes and inform future treatment strategies.
Information that must be reported includes patient demographics, treatment dosages and schedules, adverse events, treatment outcomes, response rates, and any other relevant clinical data that can provide insight into the effectiveness and safety of the therapy.
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