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

NCT ID: NCT02091050

Last Updated: 2018-08-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2017-01-31

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).

Conditions

Cervix Cancer; Endometrial Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HDR Brachytherapy 24Gy (4 x 6Gy)

Vaginal vault brachytherapy, associated or not with external beam radiotherapy.

Group Type: OTHER

2D HDR planning

Intervention Type: OTHER

HDR planning using simple radiograph (2D)

3D HDR planning

Intervention Type: OTHER

HDR planning using computed tomography (3D)

Interventions

2D HDR planning

HDR planning using simple radiograph (2D)

Intervention Type: OTHER

3D HDR planning

HDR planning using computed tomography (3D)

Intervention Type: OTHER

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

AC Camargo Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Lucas Gomes Sapienza

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

AC Camargo Cancer Center

São Paulo, São Paulo, Brazil

Countries

Brazil

References

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.

Reference Type: RESULT

PMID: 27296459 (View on PubMed)

Related Links

https://www.ncbi.nlm.nih.gov/pubmed/27296459

Related Info

Other Identifiers

AC-G 01

Identifier Type: -

Identifier Source: org_study_id