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Completed

NCT Number: NCT00165126

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.

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Key information

Age range

18 year–90 year

Sex eligibility

Female

Study type

Observational

Primary location

Brigham and Women's Hospital, Boston, Massachusetts, United States

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About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Radiation Therapy

Procedure

Given as standard therapy

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Collaborators

  • Brigham and Women's Hospital

Registry information

Important dates

Study start
2004
Primary completion
2006
Study completion
2008
First posted
Sep 14, 2005
Registry last updated
Nov 2, 2009

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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