AC Camargo Cancer Center
São Paulo, 01509 - 010, Brazil
NCT Number: NCT02091050
Demonstrate the limitations of conventional dosimetry (2D) for the adjuvant brachytherapy treatment and assess whether tridimensional dosimetry relates more faithfully with the occurrence of adverse effects.
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Notify Me18 year–85 year
Female
Interventional
Phase 2
São Paulo, 01509 - 010, Brazil
Radiotherapy is part of a multidisciplinary strategy to fight cancer in all stages, using ionizing radiation to cause damage in tumor cells. After radical surgical treatment of gynecological tumors, pathological findings, such as extension of the myometrium invasion, histologic grade, and vascular- lymphatic invasion predict the risk of locoregional recurrence of disease and, consequently, the need for adjuvant treatment. There are two main methods of adjuvant therapy after hysterectomy for malignant neoplasm of the cervix or endometrium: external beam radiotherapy with or without booster dose of vaginal vault brachytherapy or brachytherapy alone. There are few data in the literature and clinical experience with brachytherapy dimensional (3D) for adjuvant treatment of vaginal vault .
Objective: To demonstrate the limitations of conventional dosimetry (2D) for the adjuvant brachytherapy treatment and assess whether tridimensional dosimetry relates more faithfully with the occurrence of adverse effect.
Methods: A prospective study in the Department of Radiation Oncology, Antonio Candido Camargo Cancer Center will be developed with an expected duration of 14 months and will include 60 patients. Dosimetric parameters of brachytherapy treatment of vaginal vault, able to influence the incidence of adverse effects will be evaluated. Computed tomography for planning of external beam radiotherapy and brachytherapy planning will be used, after placement of intra- vaginal applicator and urinary catheter. For planning brachytherapy two fast acquisition sequences, one with a urinary catheter not pulled and pulled another with the probe will be obtained. The prescription dose obey the standard indication of document of the International Commission on Radiation Units & Measurements (ICRU 38).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
HDR planning using simple radiograph (2D)
HDR planning using computed tomography (3D)
Time frame: one week after the tomograph
Dose in bladder; rectum; small intestine; sigmoid colon; urethra; dose trigone; vaginal cuff.
Time frame: 6 weeks
Time frame: 6 weeks
toxicity associated with the genitourinary tract, using Common Terminology Criteria for Adverse Events v4.0 (CTCAE v4.0)
Time frame: 6 weeks
toxicity associated with the gastrointestinal tract, using Common Terminology Criteria for Adverse Events v4.0 (CTCAE v4.0)
Time frame: 3 Years
toxicity associated with the genitourinary tract, using Common Terminology Criteria for Adverse Events v4.0 (CTCAE v4.0)
Time frame: 3 Years
toxicity associated with the gastrointestinal tract, using Common Terminology Criteria for Adverse Events v4.0 (CTCAE v4.0)
AC Camargo Cancer Center
Other
Clinical and Dosimetric Comparison of 2D Versus 3D HDR Brachytherapy
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