Clinical trial NCT00165126: Dosimetric Analysis of Vaginal Cuff Brachytherapy in Endometrial Carcinoma
Official title: Dosimetric Analysis of Vaginal Cuff Brachytherapy in Endometrial Carcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometrial Carcinoma
Cervix Cancer
Carcinoma of the Uterus
Keywords: dosimetric analysis
vaginal cuff brachytherapy
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
First posted: 2005-09-14
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute/Brigham and Women's Hospital
name: Akila Viswanathan, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: