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Pelvic IMRT With Tomotherapy in Post-Hysterectomy Endometrial Cancer Patients

This study is currently recruiting participants.
Verified October 2012 by Washington University School of Medicine
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00334321
First received: June 6, 2006
Last updated: October 1, 2012
Last verified: October 2012
History of Changes
  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 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pelvic IMRT With Tomotherapy: A Phase I Feasibility Study in Post-Hysterectomy Endometrial Cancer Patients

Resource links provided by NLM:

MedlinePlus related topics: Cancer Hysterectomy
U.S. FDA Resources

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:
    Radiation: IMRT with Tomotherapy
    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:

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

Exclusion Criteria:

  1. Age less than 18 years of age
  2. Karnofsky Performance Status less than 60
  3. Radiographic or pathologic evidence of metastatic disease (other than pelvic or para-aortic lymph nodes)
  4. Prior pelvic radiation therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00334321

Contacts
Contact: Regina Smith (314) 454-7986 smithr@wudosis.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

Additional Information:
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00334321     History of Changes
Other Study ID Numbers: 06-0297 / 201106410
Study First Received: June 6, 2006
Last Updated: October 1, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
IMRT
Tomotherapy
Post-Hysterectomy
Endometrial Cancer

Additional relevant MeSH terms:
Endometrial Neoplasms
Sarcoma, Endometrial Stromal
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
 Uterine Diseases
Genital Diseases, Female
Neoplasms, Complex and Mixed
Neoplasms by Histologic Type
Sarcoma
Neoplasms, Connective and Soft Tissue
Endometrial Stromal Tumors

ClinicalTrials.gov processed this record on October 16, 2012