NCT01045187

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2008

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 19, 2009

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 8, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
11 months until next milestone

Results Posted

Study results publicly available

February 21, 2011

Completed
Last Updated

August 1, 2012

Status Verified

July 1, 2012

Enrollment Period

1.3 years

First QC Date

November 19, 2009

Results QC Date

January 24, 2011

Last Update Submit

July 24, 2012

Conditions

Endometrial Cancer

Keywords

endometrial cancerUterine cancerelectronic brachytherapyXoft

Outcome Measures

Primary Outcomes (1)

  • Assess Number of Patients Who Were Able to Complete Treatment Delivery Using the Axxent Electronic Brachytherapy System

    through completion of radiation therapy

Secondary Outcomes (2)

  • Assess Acute Safety Outcomes in Patients During and After Vaginal Cuff Brachytherapy Treatment With the Axxent Electronic Brachytherapy System as Incorporated in to the Physician's Current Standard of Practice

    through 3 month post treatment

  • Assess Occurence Rate of Toxicities

    through 3 month follow up post treatment

Study Arms (1)

endometrial cancer

OTHER

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

Radiation: brachytherapyRadiation: Xoft Axxent Electronic Brachytherapy System

Interventions

brachytherapyRADIATION

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.

Also known as: Electronic, Radiation, Vaginal cuff
endometrial cancer
Xoft Axxent Electronic Brachytherapy SystemRADIATION

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

Also known as: Radiation, therapy, electronic
endometrial cancer

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Post hysterectomy
  • Endometrial (uterine) cancer Stage IA Grade 1
  • Scleroderma
  • Collagen vascular disease
  • Active Lupus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Cancer Treatment Services Arizona

Casa Grande, Arizona, 85222, United States

Location

Southwest Oncology Center

Phoenix, Arizona, 85251, United States

Location

Beverly Oncology & Imaging Medical Center, Inc

Montebello, California, 90640, United States

Location

Swedish Covenant Hospital

Chicago, Illinois, 60625, United States

Location

Little Company of Mary Hospital

Evergreen Park, Illinois, 60805, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Related Publications (1)

  • 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.

    PMID: 20646289RESULT

MeSH Terms

Conditions

Endometrial NeoplasmsUterine Neoplasms

Interventions

BrachytherapyRadiationTherapeutics

Condition Hierarchy (Ancestors)

Genital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

RadiotherapyPhysical Phenomena

Limitations and Caveats

Small sample size.

Results Point of Contact

Title
Kelly W Elliott RN, MS
Organization
Xoft, Inc.
Kelliott@xoftinc.com
408-419-2428

Study Officials

  • Adam Dickler, MD

    Little Company of Mary

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2009

First Posted

January 8, 2010

Study Start

October 1, 2008

Primary Completion

January 1, 2010

Study Completion

April 1, 2010

Last Updated

August 1, 2012

Results First Posted

February 21, 2011

Record last verified: 2012-07

Locations

US(6)