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Comparison of Tomotherapy Versus Intensity-Modulated Step-and-Shoot and Conventional Radiation Treatment Plans for Patients With Locally-Advanced Squamous Cell Carcinoma of the Cervix
This study has been completed.
First Received: July 26, 2005   Last Updated: September 22, 2008   History of Changes
Sponsor: Alberta Cancer Board
Information provided by: Alberta Cancer Board
ClinicalTrials.gov Identifier: NCT00124488
  Purpose

Standard treatment for non-operable cervix cancer is radiation and chemotherapy. This treatment combination can result in significant radiation side-effects involving the bladder, small bowel and rectum. To improve results with radiation/chemotherapy, higher radiation doses have been tried for cervix cancer patients. Results from using higher radiation doses show that cervix tumours may be better controlled, but the radiation side-effects are worsened. Intensity modulated radiotherapy (IMRT) and Tomotherapy are new radiation planning and delivery technologies which may allow for delivery of higher radiation doses with less damage to normal organs. The purpose of this project is to determine whether or not IMRT and/or Tomotherapy technology can produce radiation plans that deliver higher doses of radiation to the tumor and lower doses to normal organs when compared to standard radiation plans. The results from this project will provide the basis for possibly treating future cervix cancer patients with Tomotherapy and providing them with improved cure rates along with decreased rates of radiation side effects. No patients will be treated on this protocol, as the investigators plan to only compare radiation dose calculations from different treatment plans created for test cervix cancer cases. There will be absolutely no patient contact in this protocol.


Condition Intervention
Cervix Neoplasm
Device: Tomotherapy Treatment Planning

Study Type: Observational
Study Design: Retrospective
Official Title: Comparison of Tomotherapy Versus Intensity-Modulated Step-and-Shoot and Conventional Radiation Treatment Plans for Patients With Locally-Advanced Squamous Cell Carcinoma of the Cervix

Resource links provided by NLM:


Further study details as provided by Alberta Cancer Board:

Estimated Enrollment: 10
Study Start Date: June 2005
Estimated Study Completion Date: November 2005
  Show Detailed Description

  Eligibility

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

Inclusion Criteria:

  • Squamous cell cervix cancer
  • Undergone planning computed tomography (CT) scan for radiotherapy planning
  • Treated with chemoradiotherapy

Exclusion Criteria:

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00124488

Locations
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Sponsors and Collaborators
Alberta Cancer Board
Investigators
Principal Investigator: Don Yee, MD Alberta Cancer Board
  More Information

Publications:
Thomas GM. Concurrent chemotherapy and radiation for locally advanced cervical cancer: the new standard of care. Semin Radiat Oncol. 2000 Jan;10(1):44-50. Review.
Girinsky T, Rey A, Roche B, Haie C, Gerbaulet A, Randrianarivello H, Chassagne D. Overall treatment time in advanced cervical carcinomas: a critical parameter in treatment outcome. Int J Radiat Oncol Biol Phys. 1993 Dec 1;27(5):1051-6.
Fyles A, Keane TJ, Barton M, Simm J. The effect of treatment duration in the local control of cervix cancer. Radiother Oncol. 1992 Dec;25(4):273-9.
Petereit DG, Sarkaria JN, Chappell R, Fowler JF, Hartmann TJ, Kinsella TJ, Stitt JA, Thomadsen BR, Buchler DA. The adverse effect of treatment prolongation in cervical carcinoma. Int J Radiat Oncol Biol Phys. 1995 Jul 30;32(5):1301-7.
Perez CA, Grigsby PW, Chao KS, Mutch DG, Lockett MA. Tumor size, irradiation dose, and long-term outcome of carcinoma of uterine cervix. Int J Radiat Oncol Biol Phys. 1998 May 1;41(2):307-17. Erratum in: Int J Radiat Oncol Biol Phys 1999 Nov 1;45(4):1093.
Kavanagh BD, Gieschen HL, Schmidt-Ullrich RK, Arthur D, Zwicker R, Kaufman N, Goplerud DR, Segreti EM, West RJ. A pilot study of concomitant boost accelerated superfractionated radiotherapy for stage III cancer of the uterine cervix. Int J Radiat Oncol Biol Phys. 1997 Jun 1;38(3):561-8.
MacLeod C, Bernshaw D, Leung S, Narayan K, Firth I. Accelerated hyperfractionated radiotherapy for locally advanced cervix cancer. Int J Radiat Oncol Biol Phys. 1999 Jun 1;44(3):519-24.
Viswanathan FR, Varghese C, Peedicayil A, Lakshmanan J, Narayan VP. Hyperfractionation in carcinoma of the cervix: tumor control and late bowel complications. Int J Radiat Oncol Biol Phys. 1999 Oct 1;45(3):653-6.
Nutting C, Dearnaley DP, Webb S. Intensity modulated radiation therapy: a clinical review. Br J Radiol. 2000 May;73(869):459-69. Review.

Study ID Numbers: NA-15-0004
Study First Received: July 26, 2005
Last Updated: September 22, 2008
ClinicalTrials.gov Identifier: NCT00124488     History of Changes
Health Authority: Canada: Health Canada

Keywords provided by Alberta Cancer Board:
radiotherapy planning
computer assisted radiotherapy
conformal

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Genital Neoplasms, Female
Uterine Diseases
Urogenital Neoplasms
Carcinoma
Genital Diseases, Female
Uterine Cervical Neoplasms
Neoplasms
Uterine Cervical Diseases
Neoplasms by Site
Uterine Neoplasms
Neoplasms, Squamous Cell
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 05, 2009