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Dosimetric Analysis of Vaginal Cuff Brachytherapy in Endometrial Carcinoma

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: Dana-Farber Cancer Institute
Brigham and Women's Hospital
Information provided by: Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00165126
  Purpose

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 Intervention
Endometrial Carcinoma
Cervix Cancer
Carcinoma of the Uterus
Procedure: Radiation therapy

MedlinePlus related topics:   Cancer    Cervical Cancer   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Case-Only, Prospective
Official Title:   Dosimetric Analysis of Vaginal Cuff Brachytherapy in Endometrial Carcinoma

Further study details as provided by Dana-Farber Cancer Institute:

Biospecimen Retention:   None Retained

Biospecimen Description:

Enrollment:   40
Study Start Date:   January 2004
Estimated Study Completion Date:   January 2008
Primary Completion Date:   January 2006 (Final data collection date for primary outcome measure)

Intervention Details:
    Procedure: Radiation therapy
    Given as standard 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.
  Eligibility
Ages Eligible for Study:   18 Years to 90 Years
Genders 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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00165126

Locations
United States, Massachusetts
Dana-Farber Cancer Institute    
      Boston, Massachusetts, United States, 02115
Brigham and Women's Hospital    
      Boston, Massachusetts, United States, 02115

Sponsors and Collaborators
Dana-Farber Cancer Institute
Brigham and Women's Hospital

Investigators
Principal Investigator:     Akila Viswanathan, MD, MPH     Dana-Farber Cancer Institute/Brigham and Women's Hospital    
  More Information


Responsible Party:   Dana-Farber Cancer Institute ( Akila Viswanathan, MD )
Study ID Numbers:   03-315
First Received:   September 9, 2005
Last Updated:   December 20, 2007
ClinicalTrials.gov Identifier:   NCT00165126
Health Authority:   United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:
dosimetric analysis  
vaginal cuff brachytherapy  

Study placed in the following topic categories:
Genital Diseases, Female
Uterine Cervical Neoplasms
Uterine Cervical Diseases
Endometrial Neoplasms
Genital Neoplasms, Female
Uterine Diseases
Uterine Neoplasms
Urogenital Neoplasms
Endometrial cancer
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on October 24, 2008




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