Feasibility Study Using the Xoft System for the Treatment of Endometrial Cancer

NCT ID: NCT01045187

Last Updated: 2012-08-01

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2010-04-30

Brief Summary

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Multicenter, non-randomized, feasibility study to evaluate the treatment and assess acute safety of the FDA Cleared Axxent Electronic Brachytherapy System and vaginal applicator for intracavitary vaginal cuff treatment according to the physician's current standard of care.

Detailed Description

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Conditions

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Endometrial Cancer

Keywords

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endometrial cancer Uterine cancer electronic brachytherapy Xoft

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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endometrial cancer

Patients are treated with electronic brachytherapy for an FDA cleared indication.

Group Type OTHER

brachytherapy

Intervention Type RADIATION

Electronic brachytherapy dose 21 Gy or 22 Gy in 3-4 fractions prescribed to 5mm depth, or electronic brachytherapy 16-18 Gy if EBRT is administered.

Xoft Axxent Electronic Brachytherapy System

Intervention Type RADIATION

21-22 Gy in 3-4 fractions to 5mm or 16-18 Gy in 3 fractions prescribed to the surface.

Interventions

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brachytherapy

Electronic brachytherapy dose 21 Gy or 22 Gy in 3-4 fractions prescribed to 5mm depth, or electronic brachytherapy 16-18 Gy if EBRT is administered.

Intervention Type RADIATION

Xoft Axxent Electronic Brachytherapy System

21-22 Gy in 3-4 fractions to 5mm or 16-18 Gy in 3 fractions prescribed to the surface.

Intervention Type RADIATION

Other Intervention Names

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Electronic Radiation Vaginal cuff Radiation therapy electronic

Eligibility Criteria

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Exclusion Criteria

* Post hysterectomy


* Endometrial (uterine) cancer Stage IA Grade 1
* Scleroderma
* Collagen vascular disease
* Active Lupus
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Xoft, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Adam Dickler, MD

Role: PRINCIPAL_INVESTIGATOR

Little Company of Mary

Locations

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Cancer Treatment Services Arizona

Casa Grande, Arizona, United States

Site Status

Southwest Oncology Center

Phoenix, Arizona, United States

Site Status

Beverly Oncology & Imaging Medical Center, Inc

Montebello, California, United States

Site Status

Swedish Covenant Hospital

Chicago, Illinois, United States

Site Status

Little Company of Mary Hospital

Evergreen Park, Illinois, United States

Site Status

Rhode Island Hospital

Providence, Rhode Island, United States

Site Status

Countries

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United States

References

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Dickler A, Puthawala MY, Thropay JP, Bhatnagar A, Schreiber G. Prospective multi-center trial utilizing electronic brachytherapy for the treatment of endometrial cancer. Radiat Oncol. 2010 Jul 20;5:67. doi: 10.1186/1748-717X-5-67.

Reference Type RESULT
PMID: 20646289 (View on PubMed)

Other Identifiers

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TPR-0209

Identifier Type: -

Identifier Source: org_study_id