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Dosimetric Analysis of Vaginal Cuff Brachytherapy in Endometrial Carcinoma


N/A
18 Years
90 Years
Not Enrolling
Female
Endometrial Carcinoma, Cervix Cancer, Carcinoma of the Uterus

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Trial Information

Dosimetric Analysis of Vaginal Cuff Brachytherapy in 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.


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

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Principal Investigator

Akila Viswanathan, MD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute/Brigham and Women's Hospital

Authority:

United States: Institutional Review Board

Study ID:

03-315

NCT ID:

NCT00165126

Start Date:

January 2004

Completion Date:

July 2008

Related Keywords:

  • Endometrial Carcinoma
  • Cervix Cancer
  • Carcinoma of the Uterus
  • dosimetric analysis
  • vaginal cuff brachytherapy
  • Carcinoma
  • Uterine Cervical Neoplasms
  • Adenoma
  • Endometrial Neoplasms
  • Uterine Neoplasms

Name

Location

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