2D vs 3D Planning for High-Dose Rate (HDR) Gynecological Brachytherapy

Clinical and Dosimetric Comparison of 2D Versus 3D HDR Brachytherapy

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.

Study Overview

• Status: Completed
• Conditions: Cervix Cancer; Endometrial Cancer
• Intervention / Treatment: Other: 2D HDR planning; Other: 3D HDR planning

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• Brazil
  • SP
    • São Paulo, SP, Brazil, 01509 - 010
      • AC Camargo Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: HDR Brachytherapy 24Gy (4 x 6Gy); Vaginal vault brachytherapy, associated or not with external beam radiotherapy.	Other: 2D HDR planning; HDR planning using simple radiograph (2D); Other: 3D HDR planning; HDR planning using computed tomography (3D)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dosimetry of Organs of genitourinary and gastrointestinal tracts	Dose in bladder; rectum; small intestine; sigmoid colon; urethra; dose trigone; vaginal cuff.	one week after the tomograph

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost analysis with local care.		6 weeks
Acute Genitourinary Toxicity	toxicity associated with the genitourinary tract, using Common Terminology Criteria for Adverse Events v4.0 (CTCAE v4.0)	6 weeks
Acute Gastrointestinal toxicity	toxicity associated with the gastrointestinal tract, using Common Terminology Criteria for Adverse Events v4.0 (CTCAE v4.0)	6 weeks
Late Genitourinary Toxicity	toxicity associated with the genitourinary tract, using Common Terminology Criteria for Adverse Events v4.0 (CTCAE v4.0)	3 Years
Late Gastrointestinal toxicity	toxicity associated with the gastrointestinal tract, using Common Terminology Criteria for Adverse Events v4.0 (CTCAE v4.0)	3 Years

Collaborators and Investigators

• Sponsor: AC Camargo Cancer Center

Publications and helpful links

General Publications

• 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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (ACTUAL): March 1, 2015
• Study Completion (ACTUAL): January 1, 2017

Study Registration Dates

• First Submitted: March 13, 2014
• First Submitted That Met QC Criteria: March 17, 2014
• First Posted (ESTIMATE): March 19, 2014

Study Record Updates

• Last Update Posted (ACTUAL): August 31, 2018
• Last Update Submitted That Met QC Criteria: August 29, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: endometrial cancer; cervical cancer; 3D Brachytherapy; vaginal vault brachytherapy
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Uterine Cervical Neoplasms; Endometrial Neoplasms
• Other Study ID Numbers: AC-G 01