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Completed

NCT Number: NCT02091050

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

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Key information

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

2D HDR planning

Other

HDR planning using simple radiograph (2D)

3D HDR planning

Other

HDR planning using computed tomography (3D)

Primary outcomes

  1. Dosimetry of Organs of genitourinary and gastrointestinal tracts

    Time frame: one week after the tomograph

    Dose in bladder; rectum; small intestine; sigmoid colon; urethra; dose trigone; vaginal cuff.

Secondary outcomes

  1. Cost analysis with local care.

    Time frame: 6 weeks

  2. Acute Genitourinary Toxicity

    Time frame: 6 weeks

    toxicity associated with the genitourinary tract, using Common Terminology Criteria for Adverse Events v4.0 (CTCAE v4.0)

  3. Acute Gastrointestinal toxicity

    Time frame: 6 weeks

    toxicity associated with the gastrointestinal tract, using Common Terminology Criteria for Adverse Events v4.0 (CTCAE v4.0)

  4. Late Genitourinary Toxicity

    Time frame: 3 Years

    toxicity associated with the genitourinary tract, using Common Terminology Criteria for Adverse Events v4.0 (CTCAE v4.0)

  5. Late Gastrointestinal toxicity

    Time frame: 3 Years

    toxicity associated with the gastrointestinal tract, using Common Terminology Criteria for Adverse Events v4.0 (CTCAE v4.0)

Sponsors and collaborators

Lead sponsor

AC Camargo Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2017
First posted
Mar 19, 2014
Registry last updated
Aug 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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