Intensity Modulated Radiation Therapy - Gyne Cancer (GY03.2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00188578
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : February 9, 2016
Princess Margaret Hospital, Canada
Information provided by (Responsible Party):
University Health Network, Toronto

Brief Summary:

Standard treatment for gynecological cancer is radiation therapy in two phases; whole pelvic radiation and then an internal radiation boost, also called a brachytherapy boost, to treat any remaining tumour.

The purpose of this study is to test an alternative radiation boost treatment called conformal intensity modulated radiation therapy or IMRT. Currently, we do not have complete information on the overall effectiveness of IMRT compared to brachytherapy or conformal radiotherapy. We know that IMRT allows the radiation beams to be more accurately focused on the tumor, thereby sparing more normal tissue from radiation damage and lowering risks of side effects. We are investigating the extent to which IMRT can be used to protect normal tissues in patients with cervix, uterine or vaginal cancer from the radiation beams and how much the side effects of radiation are reduced.

Condition or disease Intervention/treatment Phase
Cervix Neoplasms Uterine Neoplasms Vaginal Neoplasms Procedure: Intensity Modulated Radiation Therapy Boost Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of Conformal Intensity Modulated Radiation Therapy (IMRT) for Gynaecological Cancer Patients Not Suitable for Intracavitary Brachytherapy Boost (GY03.2)
Study Start Date : June 2003
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: IMRT Gynecological Cancers Procedure: Intensity Modulated Radiation Therapy Boost
All patients shall receive a continuous course of IMRT consisting of 25.2 Gy in 14 fractions over 3 weeks

Primary Outcome Measures :
  1. To evaluate the feasibility of using IMRT to boost the primary tumour in patients with gynecological cancers who are unsuitable for brachytherapy. [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. To evaluate the acute and late toxicity of IMRT boost. [ Time Frame: 5 years ]
  2. To evaluate tumour response and patient survival data. [ Time Frame: 5 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Biopsy-proven carcinoma of the cervix, uterus or vagina; FIGO stage T1B-4A, NO/1, MO, treated with definitive radiotherapy with or without chemotherapy, or Biopsy-proven pelvic recurrence of carcinoma of the uterus previously untreated or biopsy-proven vaginal carcinoma treated radically with radiotherapy but unsuitable for brachytherapy boost.
  • Patients not suitable for intracavitary brachytherapy.
  • ECOG performance status of 0, 1, or 2
  • Age ≥ 18 years
  • Ability to give informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00188578

Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
Princess Margaret Hospital, Canada
Principal Investigator: Anthony Fyles, MD Princess Margaret Hospital, Canada
Principal Investigator: Michael Milosevic, MD University Health Network, Princess Margaret Hospital

Responsible Party: University Health Network, Toronto Identifier: NCT00188578     History of Changes
Other Study ID Numbers: UHN REB 03-0298-C
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: February 9, 2016
Last Verified: February 2016

Additional relevant MeSH terms:
Uterine Neoplasms
Uterine Cervical Neoplasms
Vaginal Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female
Uterine Cervical Diseases
Vaginal Diseases