Clinical trial NCT02091050: 2D vs 3D Planning for High-Dose Rate (HDR) Gynecological Brachytherapy
Official title: Clinical and Dosimetric Comparison of 2D Versus 3D HDR Brachytherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cervix Cancer
Endometrial Cancer
Keywords: 3D Brachytherapy
cervical cancer
endometrial cancer
vaginal vault brachytherapy
Lead sponsor: AC Camargo Cancer Center
Sponsor class: OTHER
First posted: 2014-03-19
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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;

Primary outcomes:
measure: Dosimetry of Organs of genitourinary and gastrointestinal tracts
timeFrame: one week after the tomograph
Secondary outcomes:
measure: Cost analysis with local care.
timeFrame: 6 weeks
measure: Acute Genitourinary Toxicity
timeFrame: 6 weeks
measure: Acute Gastrointestinal toxicity
timeFrame: 6 weeks
measure: Late Genitourinary Toxicity
timeFrame: 3 Years
measure: Late Gastrointestinal toxicity
timeFrame: 3 Years
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: AC Camargo Cancer Center
state: SP
Study officials:
References:
citation: Sapienza LG, Flosi A, Aiza A, de Assis Pellizzon AC, Chojniak R, Baiocchi G. Volumetric (3D) bladder dose parameters are more reproducible than point (2D) dose parameters in vaginal vault high-dose-rate brachytherapy. Sci Rep. 2016 Jun 14;6:28074. doi: 10.1038/srep28074.