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

Primary Purpose

Cervix Cancer, Endometrial Cancer

Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
2D HDR planning
3D HDR planning
Sponsored by
AC Camargo Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervix Cancer focused on measuring 3D Brachytherapy, cervical cancer, endometrial cancer, vaginal vault brachytherapy

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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;

Sites / Locations

  • AC Camargo Cancer Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

HDR Brachytherapy 24Gy (4 x 6Gy)

Arm Description

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

Outcomes

Primary Outcome Measures

Dosimetry of Organs of genitourinary and gastrointestinal tracts
Dose in bladder; rectum; small intestine; sigmoid colon; urethra; dose trigone; vaginal cuff.

Secondary Outcome Measures

Cost analysis with local care.
Acute Genitourinary Toxicity
toxicity associated with the genitourinary tract, using Common Terminology Criteria for Adverse Events v4.0 (CTCAE v4.0)
Acute Gastrointestinal toxicity
toxicity associated with the gastrointestinal tract, using Common Terminology Criteria for Adverse Events v4.0 (CTCAE v4.0)
Late Genitourinary Toxicity
toxicity associated with the genitourinary tract, using Common Terminology Criteria for Adverse Events v4.0 (CTCAE v4.0)
Late Gastrointestinal toxicity
toxicity associated with the gastrointestinal tract, using Common Terminology Criteria for Adverse Events v4.0 (CTCAE v4.0)

Full Information

First Posted
March 13, 2014
Last Updated
August 29, 2018
Sponsor
AC Camargo Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT02091050
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
AC Camargo Cancer Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervix Cancer, Endometrial Cancer
Keywords
3D Brachytherapy, cervical cancer, endometrial cancer, vaginal vault brachytherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HDR Brachytherapy 24Gy (4 x 6Gy)
Arm Type
Other
Arm Description
Vaginal vault brachytherapy, associated or not with external beam radiotherapy.
Intervention Type
Other
Intervention Name(s)
2D HDR planning
Intervention Description
HDR planning using simple radiograph (2D)
Intervention Type
Other
Intervention Name(s)
3D HDR planning
Intervention Description
HDR planning using computed tomography (3D)
Primary Outcome Measure Information:
Title
Dosimetry of Organs of genitourinary and gastrointestinal tracts
Description
Dose in bladder; rectum; small intestine; sigmoid colon; urethra; dose trigone; vaginal cuff.
Time Frame
one week after the tomograph
Secondary Outcome Measure Information:
Title
Cost analysis with local care.
Time Frame
6 weeks
Title
Acute Genitourinary Toxicity
Description
toxicity associated with the genitourinary tract, using Common Terminology Criteria for Adverse Events v4.0 (CTCAE v4.0)
Time Frame
6 weeks
Title
Acute Gastrointestinal toxicity
Description
toxicity associated with the gastrointestinal tract, using Common Terminology Criteria for Adverse Events v4.0 (CTCAE v4.0)
Time Frame
6 weeks
Title
Late Genitourinary Toxicity
Description
toxicity associated with the genitourinary tract, using Common Terminology Criteria for Adverse Events v4.0 (CTCAE v4.0)
Time Frame
3 Years
Title
Late Gastrointestinal toxicity
Description
toxicity associated with the gastrointestinal tract, using Common Terminology Criteria for Adverse Events v4.0 (CTCAE v4.0)
Time Frame
3 Years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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;
Facility Information:
Facility Name
AC Camargo Cancer Center
City
São Paulo
State/Province
SP
ZIP/Postal Code
01509 - 010
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
27296459
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.
Results Reference
result
Links:
URL
https://www.ncbi.nlm.nih.gov/pubmed/27296459
Description
Related Info

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

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