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

Endometrial Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02091050
• Other study ID #: AC-G 01
• Status: Completed
• Phase: Phase 2
• Start date: June 2014
• Est. completion date: January 2017

Study information

• Verified date: August 2018
• Source: AC Camargo Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2017
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 85 Years

Eligibility

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;

Related Conditions & MeSH terms

• Cervix Cancer
• Endometrial Cancer
• Endometrial Neoplasms
• Uterine Cervical Neoplasms

Intervention

Other:
• 2D HDR planning
HDR planning using simple radiograph (2D)
• 3D HDR planning
HDR planning using computed tomography (3D)

Locations

Country	Name	City	State
Brazil	AC Camargo Cancer Center	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
AC Camargo Cancer Center

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

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 — View Citation

Outcome

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

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