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Dosimetric Analysis of Vaginal Cuff Brachytherapy in Endometrial Carcinoma

This study has been completed.
Sponsor:
Collaborator:
Brigham and Women's Hospital
Information provided by:
Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00165126
First received: September 9, 2005
Last updated: October 30, 2009
Last verified: October 2009
History of Changes

September 9, 2005
October 30, 2009
January 2004
January 2006   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00165126 on ClinicalTrials.gov Archive Site
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Dosimetric Analysis of Vaginal Cuff Brachytherapy in Endometrial Carcinoma
Dosimetric Analysis of Vaginal Cuff Brachytherapy in Endometrial Carcinoma

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.
  • 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.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

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.
  • Endometrial Carcinoma
  • Cervix Cancer
  • Carcinoma of the Uterus
Procedure: Radiation therapy
Given as standard therapy
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Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
July 2008
January 2006   (final data collection date for primary outcome measure)

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
Female
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00165126
03-315
Yes
Akila Viswanathan, MD, Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Principal Investigator: Akila Viswanathan, MD, MPH Dana-Farber Cancer Institute/Brigham and Women's Hospital
Dana-Farber Cancer Institute
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP