Back to resultsIntensity Modulated Radiation Therapy - Gyne Cancer (GY03.2)
Primary Purpose
Cervix Neoplasms, Uterine Neoplasms, Vaginal Neoplasms
Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Intensity Modulated Radiation Therapy Boost
Sponsored by
About this trial
This is an interventional treatment trial for Cervix Neoplasms
Eligibility Criteria
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.
Sites / Locations
- Princess Margaret Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
IMRT Gynecological Cancers
Arm Description
Outcomes
Primary Outcome Measures
To evaluate the feasibility of using IMRT to boost the primary tumour in patients with gynecological cancers who are unsuitable for brachytherapy.
Secondary Outcome Measures
To evaluate the acute and late toxicity of IMRT boost.
To evaluate tumour response and patient survival data.
Full Information
NCT ID
NCT00188578
First Posted
September 12, 2005
Last Updated
February 8, 2016
Sponsor
University Health Network, Toronto
Collaborators
Princess Margaret Hospital, Canada
1. Study Identification
Unique Protocol Identification Number
NCT00188578
Brief Title
Intensity Modulated Radiation Therapy - Gyne Cancer (GY03.2)
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 Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
Collaborators
Princess Margaret Hospital, Canada
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervix Neoplasms, Uterine Neoplasms, Vaginal Neoplasms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IMRT Gynecological Cancers
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Intensity Modulated Radiation Therapy Boost
Intervention Description
All patients shall receive a continuous course of IMRT consisting of 25.2 Gy in 14 fractions over 3 weeks
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
To evaluate the acute and late toxicity of IMRT boost.
Time Frame
5 years
Title
To evaluate tumour response and patient survival data.
Time Frame
5 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony Fyles, MD
Organizational Affiliation
Princess Margaret Hospital, Canada
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Milosevic, MD
Organizational Affiliation
University Health Network, Princess Margaret Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Intensity Modulated Radiation Therapy - Gyne Cancer (GY03.2)
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