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Dosimetric Analysis of Vaginal Cuff Brachytherapy in Endometrial Carcinoma

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ClinicalTrials.gov Identifier: NCT00165126
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : November 1, 2009
Sponsor:
Collaborator:
Brigham and Women's Hospital
Information provided by:
Dana-Farber Cancer Institute

Brief Summary:
The purpose of this study is to investigate the effect of certain variables such as the fullness of the patients bladder and the position of the treatment applicator on the dose of radiation that other organs such as the bladder and the rectum receive during radiation treatment for endometrial carcinoma.

Condition or disease Intervention/treatment
Endometrial Carcinoma Cervix Cancer Carcinoma of the Uterus Procedure: Radiation therapy

Detailed Description:
  • This study is separated into 2 phases. In phase 1, patients will be asked to have their bladder full for the second planned insertion of the brachytherapy applicator and empty for the third insertion. For phase 2, the effect of cylinder angle on normal tissue dosimetry will be investigated. Of the two bladder states assessed in phase 1 (empty or full), the one deemed to give the lower dose to the total amount of bladder tissue will be considered the standard and applied to all patients in phase 2.
  • In phase 1, to standardize bladder filling, patients will be asked to empty their bladder, then to drink 32 oz of water one and a half hours before the CT scan. The patient will undergo a treatment-planning scan after the brachytherapy cylinder is inserted and before brachytherapy treatment.
  • In phase 2, patients will be asked to fill or empty their bladder according to the results of phase 1. The vaginal cylinder will be placed horizontally for the second treatment. The cylinder will then be angled at a specific angle for the subsequent treatment.
  • A history and physical exam will be performed within 2 weeks of study entry, then at 14 days, 90 days, and 180 days following the completion of therapy.

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Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Dosimetric Analysis of Vaginal Cuff Brachytherapy in Endometrial Carcinoma
Study Start Date : January 2004
Actual Primary Completion Date : January 2006
Actual Study Completion Date : July 2008

Intervention Details:
  • Procedure: Radiation therapy
    Given as standard therapy



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with carcinoma of the uterus, post-hysterectomy stages I-IVA or vaginal cuff recurrence or post-hysterectomy cervix cancer stages IA or IB or post hysterectomy vaginal cancer stage I that will be undergoing radiation therapy.
Criteria

Inclusion Criteria:

  • Histologic documentation of carcinoma of the uterus, post-hysterectomy stages I-IVA or vaginal cuff recurrence. Or post-hysterectomy cervix cancer stages IA or IB or post hysterectomy vaginal cancer stage I.
  • ECOG performance status of less than or equal to 2
  • 18 years of age or older

Exclusion Criteria:

  • Distant metastases
  • Inoperable disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00165126


Locations
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United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Investigators
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Principal Investigator: Akila Viswanathan, MD, MPH Dana-Farber Cancer Institute/Brigham and Women's Hospital
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Responsible Party: Akila Viswanathan, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00165126    
Obsolete Identifiers: NCT00207246
Other Study ID Numbers: 03-315
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: November 1, 2009
Last Verified: October 2009
Keywords provided by Dana-Farber Cancer Institute:
dosimetric analysis
vaginal cuff brachytherapy
Additional relevant MeSH terms:
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Carcinoma
Endometrial Neoplasms
Uterine Cervical Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Uterine Cervical Diseases