Pelvic IMRT With Tomotherapy in Post-Hysterectomy Endometrial Cancer Patients

This study is currently recruiting participants.

Verified by Washington University School of Medicine, February 2009

First Received: June 6, 2006 Last Updated: February 2, 2009 History of Changes

Sponsored by:	Washington University School of Medicine
Information provided by:	Washington University School of Medicine
ClinicalTrials.gov Identifier:	NCT00334321

Purpose

This study is evaluating the feasibility of using helical tomotherapy to deliver IMRT in post-hysterectomy endometrial cancer patients receiving adjuvant radiotherapy.

Condition	Intervention	Phase
Endometrial Cancer	Radiation: IMRT with Tomotherapy	Phase I

MedlinePlus related topics: Cancer Hysterectomy Radiation Therapy

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Pelvic IMRT With Tomotherapy: A Phase I Feasibility Study in Post-Hysterectomy Endometrial Cancer Patients

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:

The study will evaluate the feasibility of using helical tomotherapy to deliver IMRT in post-hysterectomy endometrial cancer patients receiving adjuvant radiotherapy. [ Time Frame: Patients will be followed 6 weeks after final radiation treatment, every 3 months during the first two years post therapy, every 6months during years 2-5 post therapy, and annually thereafter for life. ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	40
Study Start Date:	April 2006
Estimated Study Completion Date:	April 2030
Estimated Primary Completion Date:	April 2030 (Final data collection date for primary outcome measure)

Intervention Details:

Post-surgical external beam radiation is given as Intensity Modulated Radiation Therapy (IMRT) daily 5 times a week for about 6 weeks in 160-180 cGy fractions to a total dose of 4500-5120 cGy. Helical tomotherapy will be used to plan and deliver the radiation treatment.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age greater than or equal to 18 years of age
Karnofsky Performance Status of greater than or equal to 60
FIGO Surgical Stage I, II, and III
Pathologic confirmation of endometrial cancer
Hysterectomy with bilateral salpingo-oopherectomy

Exclusion Criteria:

Age less than 18 years of age
Karnofsky Performance Status less than 60
Radiographic or pathologic evidence of metastatic disease (other than pelvic or para-aortic lymph nodes)
Prior pelvic radiation therapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00334321

Contacts

Contact: Linda M. Brockman

(314) 454-7986

brockmal@ccadmin.wustl.edu

Locations

United States, Missouri
Washington University School of Medicine	Recruiting
St. Louis, Missouri, United States, 63110

Sponsors and Collaborators

Washington University School of Medicine

Investigators

Principal Investigator:

Perry W Grigsby, M.D.

Washington University School of Medicine

More Information

No publications provided

Responsible Party:	Washington University School of Medicine ( Perry W. Grigsby, M.D. )
Study ID Numbers:	06-0297
Study First Received:	June 6, 2006
Last Updated:	February 2, 2009
ClinicalTrials.gov Identifier:	NCT00334321 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:

IMRT
Tomotherapy
Post-Hysterectomy
Endometrial Cancer

Study placed in the following topic categories:

Genital Diseases, Female
Endometrial Neoplasms
Genital Neoplasms, Female
Uterine Diseases

Uterine Neoplasms
Endometrial Cancer
Urogenital Neoplasms

Additional relevant MeSH terms:

Genital Diseases, Female
Neoplasms
Endometrial Neoplasms
Neoplasms by Site

Genital Neoplasms, Female
Uterine Diseases
Uterine Neoplasms
Urogenital Neoplasms

ClinicalTrials.gov processed this record on May 06, 2009