Brief Title
2D vs 3D Planning for High-Dose Rate (HDR) Gynecological Brachytherapy
Official Title
Clinical and Dosimetric Comparison of 2D Versus 3D HDR Brachytherapy
Brief Summary
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.
Detailed Description
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).
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Dosimetry of Organs of genitourinary and gastrointestinal tracts
Secondary Outcome
Cost analysis with local care.
Condition
Cervix Cancer
Intervention
2D HDR planning
Study Arms / Comparison Groups
HDR Brachytherapy 24Gy (4 x 6Gy)
Description: Vaginal vault brachytherapy, associated or not with external beam radiotherapy.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
60
Start Date
June 2014
Completion Date
January 2017
Primary Completion Date
March 2015
Eligibility Criteria
Inclusion Criteria:
- Malignant neoplasm of the cervix or endometrium;
- Tomography scan available in the planning system.
Exclusion Criteria:
- Patients did not undergo surgery as initial treatment;
- Patients without available tomography for planning;
Gender
Female
Ages
18 Years - 85 Years
Accepts Healthy Volunteers
No
Contacts
, ,
Location Countries
Brazil
Location Countries
Brazil
Administrative Informations
NCT ID
NCT02091050
Organization ID
AC-G 01
Responsible Party
Principal Investigator
Study Sponsor
AC Camargo Cancer Center
Study Sponsor
, ,
Verification Date
August 2018